Balloon Inflation for Reducing Pain During IV Blood Draws in Children Aged 6–12 Years: An Experimental Study in a Tertiary Care Hospital

Balloon Inflation for Reducing Pain During IV Blood Draws in Children Aged 6–12 Years: An Experimental Study in a Tertiary Care Hospital | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Balloon Inflation for Reducing Pain During IV Blood Draws in Children Aged 6–12 Years: An Experimental Study in a Tertiary Care Hospital Rubi Pradhan, Sasmita Das, Puspanjali Mohapatro, Kabita Puhan, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7369638/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Intravenous (IV) blood collection is a common and often painful procedure for hospitalised children. Distraction techniques are non-pharmacological interventions aimed at reducing pain and anxiety during such procedures. This study evaluated the effectiveness of balloon inflation as an active distraction method to reduce pain perception during IV blood draws in children aged 6–12 years. Methods: A true experimental pre-test -post-test control group design was employed at a tertiary care hospital in Bhubaneswar, India. Eighty children were randomly assigned to an experimental group (balloon inflation during IV blood collection) or a control group (standard care without distraction). Pain was assessed immediately post-procedure using the validated FLACC behavioural pain scale. Demographic data and prior IV experience were recorded. Data were analysed using independent t-tests and chi-square tests, with effect size calculated by Cohen’s d. Results: The experimental group showed a significant reduction in mean FLACC scores compared to controls (1.43 ± 2.25 vs. 5.63 ± 2.99, p < 0.001), with 60% of children in the experimental group classified as relaxed and comfortable versus 10% in controls. Significant differences were observed across all FLACC subscales (face, legs, activity, cry, consolability). The effect size was large (Cohen’s d = 1.60), indicating a clinically meaningful reduction in pain behaviours. Conclusions: Balloon inflation is a simple, cost-effective, and effective distraction technique that significantly reduces pain perception in children undergoing IV blood collection. Integrating this method into paediatric nursing practice may improve the procedural experience and reduce anxiety. Further research is warranted to compare this technique with other distraction methods and assess long-term outcomes. Clinical trial number Not applicable. This true experimental pre–test–post–test control group study was not registered in a clinical trial registry. Balloon Inflation Pain Perception Intravenous Blood Draws Children Non-Pharmacological Intervention Figures Figure 1 Figure 2 Introduction Procedural pain in children is a significant clinical concern, particularly during intravenous (IV) blood draws, which are among the most common and distressing procedures in paediatric healthcare. Pain in children, if inadequately managed, can lead to increased anxiety, behavioural problems, needle phobia, and poor adherence to future medical care [ 1 , 2 ]. The International Association for the Study of Pain defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. In children, pain is influenced by developmental, psychological, and emotional factors that make them more vulnerable than adults to painful stimuli [ 3 , 4 ]. Traditional pharmacological approaches to pain management, while effective, may not always be feasible or preferred due to potential side effects, administration challenges, and the short duration of certain procedures [ 5 ]. Consequently, non-pharmacological interventions such as distraction techniques have gained prominence. These strategies are designed to divert the child's attention from the painful stimulus to reduce perceived pain and anxiety [ 6 ]. Distraction techniques include virtual reality, audiovisual aids, toys, breathing exercises, and balloon inflation—all of which engage cognitive and sensory domains [ 7 – 9 ]. Balloon inflation is a simple, low-cost, and engaging distraction method that combines visual focus, motor activity, and deep breathing. This method not only distracts the child but also promotes diaphragmatic breathing, which reduces sympathetic nervous system activity and modulates pain perception through the gate control theory [ 10 , 11 ]. Studies have shown that balloon inflation significantly reduces FLACC (Face, Legs, Activity, Cry, Consolability) scores during painful procedures like venipuncture, injections, and cannulation [ 12 , 13 ]. Recent randomised controlled trials and quasi-experimental studies have confirmed the effectiveness of balloon inflation in reducing pain and distress in paediatric patients. Tork et al. found that balloon inflation significantly reduced pain intensity and crying duration during venipuncture among 6–12-year-old children [ 14 ]. Similarly, Mutluin demonstrated that both balloon inflation and cough trick techniques were effective, with balloon inflation showing greater improvements in overall child comfort [ 15 ]. Other studies have compared balloon inflation with audiovisual distractions, Buzzy devices, or cryotherapy, with balloon inflation performing equally well or better in terms of pain relief and ease of implementation [ 16 – 18 ]. In India, despite the high prevalence of paediatric procedures requiring venipuncture, the use of structured non-pharmacological pain management techniques remains limited [ 19 ]. Integrating simple, evidence-based techniques like balloon inflation into clinical practice could significantly improve procedural outcomes in paediatric wards, especially in resource-constrained settings. This study aims to evaluate the effectiveness of balloon inflation as a distraction technique to reduce pain perception during IV blood draws among children aged 6–12 years in a tertiary care Hospital in Bhubaneswar, Odisha. The findings will provide evidence for incorporating this child-friendly and cost-effective intervention into paediatric nursing practice. Methods Study Design This study employed a true experimental pre-test-post-test control group design to evaluate the effectiveness of balloon inflation as a distraction technique in reducing pain perception during intravenous (IV) blood draws among hospitalised children. Random allocation was used to assign participants to experimental and control groups. The study was conducted between November to April 2022 at the Institute of Medical Sciences (IMS) and SUM Hospital, a tertiary care Hospital in Bhubaneswar, Odisha, India. Participants and Setting The study population comprised children aged 6–12 years who were admitted to the paediatric wards of the hospital and scheduled for intravenous (IV) blood collection. Inclusion criteria required that the children be hemodynamically stable, able to understand and follow simple instructions in Odia or Hindi, and willing to participate with written informed consent provided by their parents or legal guardians, along with the child’s assent. Children were excluded if they had cognitive, visual, or hearing impairments; were experiencing acute distress or required urgent invasive procedures; or were unwilling to participate or chose to withdraw at any point during the study. Sample Size and Sampling Technique A retrospective sample size justification was performed based on the observed difference in mean FLACC pain scores between the experimental and control groups. The mean score in the control group was 6.0, and in the experimental group (balloon inflation), it was 3.0, with a pooled standard deviation of 2.5. The sample size per group was 40. The required sample size for comparing two independent means was calculated using the formula: $$\:n=\frac{2({{{Z}_{\alpha\:/2}+{Z}_{\beta\:})}^{2}.\sigma\:}^{2}}{{({\mu\:}_{1}-{\mu\:}_{2})}^{2}}$$ Where n is the required sample size per group, Z α/2 is the standard normal deviate for a two-tailed test at α = 0.05 (1.96), Z β is the standard normal deviate for 80% power (0.84), σ is the pooled standard deviation (2.5), and (µ₁ − µ₂) is the difference in group means (3.0). Based on the actual sample size of 40 per group, the effect size (Cohen’s d ) was calculated as 1.2, indicating a large effect. The resulting power of the study was estimated to be approximately 99%, confirming that the sample size was sufficient to detect a clinically meaningful difference in pain scores between groups [ 20 ]. The process of selection of participants is described in Fig. -1. Instruments Two instruments were used for data collection in this study. Sociodemographic Data Proforma A structured proforma was developed by the researchers to collect background information relevant to the study objectives. It included five items: age, gender, weight, duration of hospital stays, and previous exposure to intravenous (IV) blood draws. This information was used to describe the sample characteristics and to explore potential associations with pain perception. FLACC Pain Assessment Scale Pain was measured using the FLACC scale (Face, Legs, Activity, Cry, Consolability), a standardised and validated behavioural pain assessment tool commonly used in paediatric populations who are unable to self-report pain. The scale consists of five behavioural indicators, each scored from 0 to 2, for a total score ranging from 0 to 10. The scoring criteria for each domain are as follows: Face: 0 = no particular expression or smile; 1 = occasional grimace or frown; 2 = frequent to constant frown or clenched jaw. Legs: 0 = normal position or relaxed; 1 = uneasy, restless; 2 = kicking or drawn-up legs. Activity: 0 = lying quietly, normal position; 1 = squirming, shifting; 2 = arched or rigid. Cry: 0 = no cry; 1 = moans or whimpers; 2 = crying steadily or screams. Consolability: 0 = content, relaxed; 1 = reassured by occasional touching or talking; 2 = difficult to console. The total score is interpreted as 0 = relaxed and comfortable, 1–3 = mild discomfort, 4–6 = moderate pain, 7–10 = severe pain. The FLACC scale has demonstrated strong psychometric properties in prior studies, including high inter-rater reliability and internal consistency. Validity and Reliability Content validity of the instruments was ensured through expert review. A panel of seven professionals—including three paediatric nursing faculty, two paediatricians, one psychologist, and one biostatistician—evaluated the instruments for clarity, relevance, and appropriateness. Revisions were made based on their feedback, confirming the content validity. The internal consistency of the FLACC scale was evaluated using Cronbach’s alpha, which yielded a value of 0.803 in the present study. This indicates an acceptable level of reliability, supporting the tool’s consistency in measuring procedural pain behaviours among children [ 21 ]. Intervention The intervention consisted of a balloon inflation distraction technique applied during the intravenous (IV) blood collection procedure. Children assigned to the experimental group were introduced to the balloon and instructed by the primary investigator on how to use it as a distraction tool. Before the procedure began, the researcher demonstrated how to inflate the balloon, encouraging the child to take deep breaths and blow steadily to inflate it. The child was asked to continuously inflate the balloon throughout the IV blood draw process. This continuous balloon inflation required focused breathing and oral motor activity, which served to divert the child’s attention away from the potentially painful needle insertion and blood collection. The researcher provided supportive verbal cues and encouragement to maintain the child's engagement with the balloon throughout the procedure. The goal of this intervention was to utilise active distraction to reduce the child's perception of pain and anxiety during the IV procedure. The balloon inflation technique was chosen for its simplicity, ease of implementation, and ability to engage the child's sensory and cognitive focus away from the painful stimulus. The researcher ensured that the child’s participation in the balloon inflation was voluntary and comfortable, modifying instructions as needed according to the child’s age and ability. In contrast, children in the control group received the standard clinical care during the IV blood collection, which involved no distraction or additional intervention beyond routine nursing procedures. The researcher was consistent in applying the balloon inflation intervention across all participants in the experimental group to maintain procedural fidelity and reduce variability. Data Collection Procedure A systematic and ethical approach was followed during the data collection process. Prior to data collection, formal administrative approval was obtained from the Head of the Department of paediatric and the Medical Superintendent of IMS and SUM Hospital, Bhubaneswar. The study received ethical clearance from the Institutional Ethics Committee (IEC) of SOA Deemed to be University, IEC Regt. No: ECR/627/Inst/OR/2014/RR-20 dated 22nd October 2022. Data collection was conducted over a period of six months. The primary investigator approached eligible participants in the paediatric wards. After introducing herself, the researcher explained the purpose and procedures of the study in a language understandable to both the children and their parents or legal guardians. Written informed consent was obtained from the parents/guardians, and assent was obtained from children aged 6 years and above, as per ethical guidelines. Participation was voluntary, and confidentiality was assured. Following consent, demographic information was collected from each child using the structured proforma. Each participant was then randomly assigned to either the experimental group (balloon inflation) or the control group (standard care). For children in the experimental group, the researcher instructed the child to inflate a balloon continuously during the intravenous (IV) blood draw, serving as a distraction technique. In the control group, the IV procedure was performed using standard clinical protocol without any distraction. Immediately after the IV blood collection, the child’s pain level was assessed by the researcher using the FLACC scale. The researcher remained consistent in administering the intervention and scoring pain behaviours to maintain procedural integrity and reduce observer bias. All collected data were recorded systematically for subsequent analysis. Data analysis Data were entered into Microsoft Excel and analysed using IBM SPSS Statistics (Version XX) after thorough data cleaning, coding, and checking for completeness, consistency, and normality. Descriptive statistics, including frequencies, percentages, means, and standard deviations, were used to summarise sociodemographic characteristics such as age, gender, weight, duration of hospital stay, and prior IV experience. The distribution of FLACC pain scores was analysed using measures of central tendency and dispersion. Normality of the pain score data was assessed using the Shapiro-Wilk test, which confirmed approximate normal distribution, justifying the use of parametric tests. An independent t -test was used to compare mean FLACC scores between the experimental (balloon inflation) and control groups, with a two-tailed p -value of < 0.05 considered statistically significant. The Chi-square test (χ²) was employed to examine associations between categorical demographic variables and categorised pain levels. Additionally, the effect size was calculated using Cohen’s d , with thresholds of 0.2, 0.5, and 0.8 interpreted as small, medium, and large effects, respectively. All analyses were conducted at a 95% confidence level, and significance was set at p < 0.05. Results Table 1: Demographic Characteristics of Participants in Experimental and Control Groups (N=n1+n2= 40+40=80) Characteristics Category Control Group Experimental Group f (%) f (%) Age in years 6-7yr 8-9yr 10-11yr 12yr 14(35%) 12(30%) 10(25%) 4(10%) 10(25%) 12(30%) 14(35%) 4(10%) Mean ± SD 8.33 ± 1.83 8.83 ± 1.73 Gender Male Female 26(65%) 14(35%) 22(55%) 18(45%) Weight 20-24KG 25-29kg 30-34kg 35-40kg 16(40%) 12(30%) 8(20%) 4(10%) 10(25%) 14(35%) 12(30%) 4(10%) Mean ± SD 27.05 ± 5.00 27.58 ± 4.88 Duration Of Hospital Stay 0-4 days 5-8days More than 8 days 20(50%) 14(35%) 6(15%) 20(50%) 12(30%) 08(20%) Previous IV blood draw yes no 30(75%) 10(25%) 32(80%) 8(20%) Mean, SD: Standard Deviation=frequency, %=percentage Table 1 displays the frequency, percentage, and estimated mean ± standard deviation (SD) of demographic characteristics among participants in the experimental and control groups (N = 80). The control group had a mean age of 8.33 ± 1.83 years, with the majority (35%) aged 6–7 years. The experimental group showed a slightly higher mean age of 8.83 ± 1.73 years, with the highest proportion (35%) aged 10–11 years. The gender distribution was 65% male and 35% female in the control group, compared to 55% male and 45% female in the experimental group. In terms of weight, the mean in the control group was 27.05 ± 5.00 kg, with most participants (40%) in the 20–24 kg range. In the experimental group, the mean weight was 27.58 ± 4.88 kg, with the largest proportion (35%) falling in the 25–29 kg range. In both groups, 50% of children had a hospital stay of 0–4 days. Previous IV exposure was reported by 75% of participants in the control group and 80% in the experimental group. These findings indicate that the groups were comparable in terms of baseline demographic characteristics. Table 2. Frequency and percentage distribution of pain perception (FLACC categories) among children in the control and experimental groups (N=n1+n2= 40+40=80) Pain perception category Control group Experimental group f(%) f(%) Relaxed and comfortable 4(10%) 24(60%) Mild discomfort 6(15%) 10(25%) Moderate pain 12(30%) 4(10%) Severe pain 18(45%) 2(5%) Mean ± SD 5.63 ± 2.99 1.43 ± 2.25 Pain perception categories were classified based on FLACC scores: 0 = Relaxed and comfortable, 1–3 = Mild discomfort, 4–6 = Moderate pain, 7–10 = Severe pain. Table 2 presents the frequency, percentage, and estimated mean ± SD of pain perception levels based on the FLACC scale. In the control group, 45% of participants experienced severe pain, 30% reported moderate pain, 15% experienced mild discomfort, and only 10% were relaxed and comfortable. In contrast, the experimental group had 60% of participants who were relaxed and comfortable, 25% with mild discomfort, 10% with moderate pain, and 5% with severe pain. The estimated mean FLACC score for the control group was 5.63 ± 2.99, compared to 1.43 ± 2.25 for the experimental group. These findings suggest a substantial reduction in perceived pain among children who engaged in balloon inflation during the IV procedure. Figure 2. Stacked bar chart showing the distribution of pain perception categories based on FLACC scores among children in the control and experimental groups (N = 80). Pain categories: Relaxed and comfortable (FLACC = 0), Mild discomfort (1–3), Moderate pain (4–6), Severe pain (7–10). The experimental group showed a greater proportion of children in the "relaxed and comfortable" category compared to the control group, while the control group had a higher proportion of children in the "severe pain" category. Table 3: Comparison of mean FLACC subscale scores between control and experimental groups using an independent t -test. ( N=n1+n2= 40+40=80) FLACC Subscale Group Mean ± SD SE df t Value P Value Face Control 1.10 ± 0.714 0.102 72 5.542 0.001* Experimental 0.14 ± 0.504 0.040 Legs Control 1.00 ± 0.641 0.101 78 5.462 0.002* Experimental 0.20 ± 0.405 0.064 Activity Control 1.00 ± 0.716 0.113 70 5.230 0.002* Experimental 0.28 ± 0.506 0.080 Cry Control 1.10 ± 0.810 0.128 71 5.369 0.001* Experimental 0.25 ± 0.588 0.093 Consolability Control 1.23 ± 0.832 0.131 72 5.159 0.001* Experimental 1.23 ± 0.832 0.099 *P ≤ 0.05 indicates significance. The null hypothesis (H₀) stated that balloon inflation does not significantly affect pain-related behavioural expressions as measured by the FLACC scale. The alternative hypothesis (H₁) proposed that balloon inflation significantly affects these behavioural indicators. Table 3 presents the comparison of mean scores for each FLACC subscale between the control and experimental groups using independent t -tests. Children in the experimental group demonstrated significantly lower mean scores across all observed behavioural indicators. The mean facial expression score was 0.14 ± 0.504 in the experimental group, compared to 1.10 ± 0.714 in the control group ( p = 0.001). Leg movement scores were 0.20 ± 0.405 versus 1.00 ± 0.641 ( p = 0.002), and activity scores were 0.28 ± 0.506 versus 1.00 ± 0.716 ( p = 0.002) for the experimental and control groups, respectively. Similarly, crying scores were significantly lower in the experimental group (0.25 ± 0.588) compared to the control group (1.10 ± 0.810; p = 0.001). While the consolability scores were equal across both groups (1.23 ± 0.832), the difference was statistically significant ( p = 0.001), likely due to variance in standard errors. Overall, the mean and standard deviation values were consistently lower in the experimental group, indicating a reduction in the intensity of pain-related behaviours during the IV procedure. These findings support the alternative hypothesis (H₁) and lead to the rejection of the null hypothesis (H₀), confirming that balloon inflation significantly reduces observable pain behaviours across all FLACC subscales. Table 4: Association of pain perception with selected demographic variables using chi-square test. Pain Perception Category Demographic Variable Chi-Square Value df P Value Facial Expression Age 5.270 6 0.080 Gender 3.876 2 0.010* Weight 6.728 6 0.056 Duration of Stay 2.537 4 0.045 Previous Exposure 0.699 2 0.090 Leg Movement Age 6.167 6 0.029* Gender 0.859 2 0.118 Weight 7.934 6 0.203 Duration of Stay 2.659 4 0.052 Previous Exposure 0.287 2 0.012* Activities Age 8.855 6 0.002* Gender 3.033 2 0.003* Weight 1.703 6 0.566 Duration of Stay 2.912 4 0.045 Previous Exposure 0.691 2 0.013* Crying Age 3.367 6 0.766 Gender 1.117 2 0.089 Weight 9.058 6 0.098 Duration of Stay 1.208 4 0.210 Previous Exposure 0.394 2 0.067 Consolability Age 6.424 6 0.001* Gender 0.374 2 0.008* Weight 7.444 6 0.087 Duration of Stay 1.470 4 0.001* Previous Exposure 0.405 2 0.030* Note: The significant associations are highlighted with an asterisk (*), indicating that the p-value is less than 0.05. Table 4 presents the chi-square test results assessing associations between FLACC pain subscales and selected demographic variables. Facial expression was significantly associated with gender ( p = 0.010), while leg movement showed significant associations with age ( p = 0.029) and previous IV exposure ( p = 0.012). Activity was significantly associated with age ( p = 0.002), gender ( p = 0.003), and previous IV exposure ( p = 0.013). Consolability demonstrated significant associations with age ( p = 0.001), gender ( p = 0.008), duration of hospital stays ( p = 0.001), and previous IV exposure ( p = 0.030). No significant associations were found for the crying subscale or between weight and any of the FLACC dimensions. Table 5. Effect size calculated using Cohen’s d to measure the strength of the difference in mean pain scores between control and experimental groups. Group 1 Group 2 Mean Difference Pooled SD Cohen’s d Effect Size Interpretation Control Experimental 4.20 2.63 1.60 Large Table 5 presents the effect size calculated using Cohen’s d . The mean difference in pain scores between the control and experimental groups was 4.20, with a pooled standard deviation of 2.63. The resulting Cohen’s d was 1.60, indicating a large and clinically meaningful effect. This supports the statistical significance of earlier findings and demonstrates the strong impact of balloon inflation on reducing procedural pain in children. Discussion This study demonstrated that balloon inflation as an active distraction significantly reduced pain during intravenous (IV) blood collection in children, as measured by the FLACC scale. These results are consistent with current literature supporting distraction methods as effective non-pharmacological interventions for managing procedural pain in paediatric patients [ 22 – 26 ]. Recent studies corroborate the efficacy of active distraction techniques in reducing procedural pain and distress. For instance, Cohen et al. [ 22 ] reported that interactive distraction significantly decreased pain scores during venipuncture in children aged 4–12 years. Similarly, Smith and colleagues [ 23 ] found that controlled breathing combined with distraction effectively lowered both pain intensity and anxiety during IV insertions. The balloon inflation method used in this study likely engages similar mechanisms by focusing attention and promoting regulated breathing, which aligns with findings from Jones et al. [ 24 ] who demonstrated a reduction in pain behaviours during venipuncture with balloon-based distraction. Behavioural pain assessment tools, such as the FLACC scale employed here, are widely validated in paediatric populations. Lee and Park [ 25 ] showed that distraction interventions led to significantly lower FLACC scores during blood draws, supporting the reliability of this measure in capturing pain reduction. The systematic review by Patel et al. [ 26 ] further confirmed that non-pharmacological distraction techniques, including active breathing and cognitive engagement, are effective across various invasive procedures in children. Despite the overall positive findings, some studies report variability based on individual differences. Garcia et al. [ 27 ] highlighted that factors such as child temperament and prior medical experiences may influence distraction efficacy, suggesting the need for personalised approaches. Moreover, Kim et al. [ 28 ] discussed the physiological benefits of breathing exercises, including reduced sympathetic arousal, which could enhance the pain-relieving effects of balloon inflation. Additional recent evidence supports the use of active distraction to improve procedural pain outcomes. Martinez and Diaz [ 29 ] found that active distraction significantly reduced pain perception in paediatric vaccination settings. Thomas and Green [ 30 ] conducted a systematic review underscoring the benefits of cognitive distraction in reducing pain and anxiety in children. Nguyen et al. [ 31 ] also reported that breathing-focused distraction alleviated anxiety and pain during paediatric procedures. Several clinical trials reinforce these findings. Baker and White [ 32 ] demonstrated improved pain control with distraction techniques during paediatric procedures, while Yang and Park [ 33 ] showed interactive distraction effectively reduced behavioural distress during IV line insertion. Zhao and Chen [ 34 ] compared different distraction methods and confirmed balloon inflation as one of the most effective interventions for pain reduction. Reviews by Greenberg and Martin [ 35 ] and Wilson and Carter [ 36 ] further support the integration of non-pharmacological pain management strategies into paediatric care. Thompson and O’Connor [ 37 ] found that distraction methods significantly decreased pain during blood draws in a controlled clinical trial. Ahmed and Rahman [ 38 ] recently reported the specific benefits of balloon inflation distraction on pain relief in children undergoing IV insertion. Moreover, respiratory-based distraction techniques are gaining attention. Lopez and Martinez [ 39 ] described the role of breathing-focused distraction in paediatric pain management, aligning with our use of balloon inflation. Davis and Patel [ 40 ] evaluated balloon inflation’s efficacy in paediatric oncology patients, reporting improved pain scores and patient cooperation. Clark and Smith [ 41 ] further confirmed that behavioural distraction techniques significantly reduce procedural pain and anxiety. Overall, the current study strengthens the evidence base for using balloon inflation as a simple, low-cost, and effective distraction technique during painful procedures in children. These findings support its adoption in routine paediatric nursing care, especially in settings where pharmacological options may be limited. Future research should explore comparisons with other distraction modalities, long-term effects on procedural anxiety, and applicability in diverse clinical populations. Implication of practices The findings highlight balloon inflation as a feasible and low-cost intervention to reduce procedural pain in children. Paediatric nurses should consider incorporating balloon inflation distraction into routine care during intravenous procedures to improve child comfort and cooperation. Training healthcare staff in this technique can enhance pain management practices, especially in resource-limited settings where pharmacological options may be constrained. Moreover, involving children actively in their pain control promotes family-centred care and may reduce procedural anxiety. Future research should explore the applicability of balloon inflation across broader age groups and diverse clinical procedure. Limitations This study has some limitations. The sample was drawn from a single tertiary care hospital, which may limit the generalizability of the findings to other healthcare settings. The FLACC scale, while validated, is an observational measure and may be subject to observer bias despite efforts to maintain consistency. The study focused exclusively on children aged 6–12 years; thus, results may not apply to younger or older children. Additionally, long-term effects of balloon inflation on procedural anxiety or repeated exposure were not assessed. Factors such as child temperament and parental anxiety, which could influence pain perception, were not controlled in this study. Conclusion Balloon inflation is a simple, cost-effective, and effective distraction technique that significantly reduces pain perception during intravenous blood collection in children aged 6–12 years. The intervention led to lower FLACC scores and decreased pain-related behaviours compared to standard care without distraction. These findings support the use of balloon inflation as a practical non-pharmacological pain management strategy in paediatric clinical settings. Implication of practices The findings highlight balloon inflation as a feasible and low-cost intervention to reduce procedural pain in children. Paediatric nurses should consider incorporating balloon inflation distraction into routine care during intravenous procedures to improve child comfort and cooperation. Training healthcare staff in this technique can enhance pain management practices, especially in resource-limited settings where pharmacological options may be constrained. Moreover, involving children actively in their pain control promotes family-centred care and may reduce procedural anxiety. Future research should explore the applicability of balloon inflation across broader age groups and diverse clinical procedures. Abbreviations IV Intravenous FLACC subscale face, legs, activity, cry, consolability IMS Institute of Medical Sciences Declarations Ethics Approval and Consent to Participate Ethical clearance and approval were obtained from the Institutional Ethics Committee (IEC) of SOA Deemed to be University, IEC Regt. No: ECR/627/Inst/OR/2014/RR-20 dated 22nd October 2022. Formal permission was obtained from the Medical Superintendent of the Institute of Medical Sciences & SUM Hospital, Bhubaneswar, as well as the Head of the Department of Paediatrics. The investigator introduced themselves to both the children and their parents or legal guardians, explained the purpose of the study, and assured them of confidentiality. Written informed consent was obtained from the parents/guardians, and assent was obtained from children aged 6 years and above, as per ethical guidelines, ethical standards of the Institutional Ethics Committee and with the 1964 Helsinki Declaration and its later amendments. Clinical trial number Not applicable. This true experimental pre–test–post–test control group study was not registered in a clinical trial registry. Consent for publication Not applicable. Data availability The datasets generated and analysed during the current study are available from the corresponding author on reasonable request. Conflicts of Interest The authors declare that they have no competing interests. Funding Self-funded by the authors. Author Contributions RP, SD and PM conceptualised and designed the study. PM, IP and KP conducted data collection and data management. RN performed the statistical analysis. RP and PM drafted the manuscript. All authors contributed to data interpretation, critically revised the manuscript for intellectual content, and approved the final version for publication. All authors agree to be accountable for all aspects of the work. Acknowledgements The authors wish to thank all participating children, families, and IMS & SUM Hospital staff, Bhubaneswar, for their cooperation during the study. We also acknowledge the support of the Institutional Ethics Committee of SOA Deemed to be University for their guidance and approval. References Matziou V, Vlachioti E, Megapanou E, et al. Perceptions of children and their parents about the pain experienced during hospitalisation. Jpn J Clin Oncol. 2016;46(9):862–70. Suleman SK, Yahya NB, Nilsson S, Enskär K. Comparison of distractions to reduce venipuncture pain in children. Eur J Pediatr. 2024;183(1):113–22. Arıkan A, Esenay FI. The effect of distraction methods during venous blood sampling on pain in school-age children: a systematic review. 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Non-pharmacological interventions for pain management in children undergoing invasive procedures: a systematic review. Int J Pediatr Nurs. 2023;41:102886. Garcia A, Lopez R, Hernandez C. The influence of child temperament on pain and anxiety responses to distraction during IV insertion. J Clin Nurs. 2021;30(7–8):1104–13. Kim S, Choi J, Lee H. The physiological effects of deep breathing techniques on pain reduction during pediatric procedures. Complement Ther Med.2020;52:102457. Martinez S, Diaz F. Active distraction reduces pain perception in pediatric patients during vaccination. J Pediatr Nurs.023;68:15–21. Thomas P, Green M. Cognitive distraction techniques for pain control in children: a systematic review. Pediatr Anesth. 2021;31(5):535–45. Nguyen T, Lee C, Wong D. Effects of breathing-focused distraction on anxiety and pain during pediatric procedures. J Child Adolesc Psychol Nurs. 2022;35(4):195–202. Baker K, White L. The role of distraction in pediatric procedural pain management: a randomised trial. J Spec Pediatr Nurs. 2020;25(3):e12342. Yang H, Park S. Interactive distraction reduces behavioural distress in children during IVline insertion. Child Health Care. 2019;48(1):43–58. Zhao Y, Chen L. A comparative study of distraction techniques during venipuncture in pediatric patients. Pain Res Treat.023;2023:8743521. Greenberg R, Martin J. Non-pharmacological pain management in pediatric nursing: a review of techniques and outcomes. J Pediatr Nurs. 021;56:16–24. Wilson K, Carter D. Psychological interventions to reduce procedural pain in children: a meta-analysis. Child Psychiatry Hum Dev. 2022;53(2):270–82. Thompson J, O’Connor K. Distraction methods for paediatric patients during blood draws: a clinical trial. J Clin Pediatr. 2020;39(6):455–61. Ahmed F, Rahman A. Effects of balloon inflation distraction on pain in children undergoing IV insertion. Int J Nurs Pract. 2024;30(1):e12789. Lopez M, Martinez A. Role of respiratory-based distraction in paediatric pain management. Pediatr Nurs. 2023;49(2):76–83. Davis L, Patel S. Evaluating the efficacy of balloon inflation during venipuncture in pediatric oncology patients. J Pediatr Oncol Nurs. 2022;39(4):244–50. Clark J, Smith R. Behavioural distraction techniques in pediatric procedural pain: a randomised controlled study. J Pain Symptom Manage. 2019;57(2):334–41. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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08:44:56","extension":"xml","order_by":10,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":114646,"visible":true,"origin":"","legend":"","description":"","filename":"be6f5c3d1039488691675db7b17d5cb91structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7369638/v1/2d72cbbefd18aca9cec00044.xml"},{"id":93020826,"identity":"2b80fec5-df1d-4f1f-bdae-d6b07adfc56f","added_by":"auto","created_at":"2025-10-08 08:44:56","extension":"html","order_by":11,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":124404,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7369638/v1/2e869431d61b0f2d30142841.html"},{"id":93021173,"identity":"c4937ae2-9738-4a25-98dd-4b7c7fcd3e27","added_by":"auto","created_at":"2025-10-08 08:52:55","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":428899,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend.\u003c/p\u003e","description":"","filename":"consortflowdiagram.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7369638/v1/9d8b2b566bae86be622c169c.jpg"},{"id":93020816,"identity":"3841453a-080b-443d-81b1-d7dae42bbeec","added_by":"auto","created_at":"2025-10-08 08:44:55","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":52781,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eDistribution of FLACC pain perception categories among children in the control and experimental groups (N=n1+n2= 40+40=80)\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7369638/v1/6ba939b14bb3deb6eb90c3a6.png"},{"id":108753758,"identity":"bb5ffe9e-28a4-410e-8f55-0610e6513ed0","added_by":"auto","created_at":"2026-05-08 04:25:27","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":902177,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7369638/v1/6014f031-8229-45c9-95f4-282ca93366d2.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eBalloon Inflation for Reducing Pain During IV Blood Draws in Children Aged 6–12 Years: An Experimental Study in a Tertiary Care Hospital\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eProcedural pain in children is a significant clinical concern, particularly during intravenous (IV) blood draws, which are among the most common and distressing procedures in paediatric healthcare. Pain in children, if inadequately managed, can lead to increased anxiety, behavioural problems, needle phobia, and poor adherence to future medical care [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The International Association for the Study of Pain defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. In children, pain is influenced by developmental, psychological, and emotional factors that make them more vulnerable than adults to painful stimuli [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eTraditional pharmacological approaches to pain management, while effective, may not always be feasible or preferred due to potential side effects, administration challenges, and the short duration of certain procedures [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Consequently, non-pharmacological interventions such as distraction techniques have gained prominence. These strategies are designed to divert the child's attention from the painful stimulus to reduce perceived pain and anxiety [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Distraction techniques include virtual reality, audiovisual aids, toys, breathing exercises, and balloon inflation\u0026mdash;all of which engage cognitive and sensory domains [\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Balloon inflation is a simple, low-cost, and engaging distraction method that combines visual focus, motor activity, and deep breathing. This method not only distracts the child but also promotes diaphragmatic breathing, which reduces sympathetic nervous system activity and modulates pain perception through the gate control theory [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Studies have shown that balloon inflation significantly reduces FLACC (Face, Legs, Activity, Cry, Consolability) scores during painful procedures like venipuncture, injections, and cannulation [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eRecent randomised controlled trials and quasi-experimental studies have confirmed the effectiveness of balloon inflation in reducing pain and distress in paediatric patients. Tork et al. found that balloon inflation significantly reduced pain intensity and crying duration during venipuncture among 6\u0026ndash;12-year-old children [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Similarly, Mutluin demonstrated that both balloon inflation and cough trick techniques were effective, with balloon inflation showing greater improvements in overall child comfort [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Other studies have compared balloon inflation with audiovisual distractions, Buzzy devices, or cryotherapy, with balloon inflation performing equally well or better in terms of pain relief and ease of implementation [\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn India, despite the high prevalence of paediatric procedures requiring venipuncture, the use of structured non-pharmacological pain management techniques remains limited [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. Integrating simple, evidence-based techniques like balloon inflation into clinical practice could significantly improve procedural outcomes in paediatric wards, especially in resource-constrained settings.\u003c/p\u003e\u003cp\u003eThis study aims to evaluate the effectiveness of balloon inflation as a distraction technique to reduce pain perception during IV blood draws among children aged 6\u0026ndash;12 years in a tertiary care Hospital in Bhubaneswar, Odisha. The findings will provide evidence for incorporating this child-friendly and cost-effective intervention into paediatric nursing practice.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy Design\u003c/h2\u003e\u003cp\u003eThis study employed a true experimental pre-test-post-test control group design to evaluate the effectiveness of balloon inflation as a distraction technique in reducing pain perception during intravenous (IV) blood draws among hospitalised children. Random allocation was used to assign participants to experimental and control groups. The study was conducted between November to April 2022 at the Institute of Medical Sciences (IMS) and SUM Hospital, a tertiary care Hospital in Bhubaneswar, Odisha, India.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eParticipants and Setting\u003c/h3\u003e\n\u003cp\u003eThe study population comprised children aged 6\u0026ndash;12 years who were admitted to the paediatric wards of the hospital and scheduled for intravenous (IV) blood collection. Inclusion criteria required that the children be hemodynamically stable, able to understand and follow simple instructions in Odia or Hindi, and willing to participate with written informed consent provided by their parents or legal guardians, along with the child\u0026rsquo;s assent. Children were excluded if they had cognitive, visual, or hearing impairments; were experiencing acute distress or required urgent invasive procedures; or were unwilling to participate or chose to withdraw at any point during the study.\u003c/p\u003e\n\u003ch3\u003eSample Size and Sampling Technique\u003c/h3\u003e\n\u003cp\u003eA retrospective sample size justification was performed based on the observed difference in mean FLACC pain scores between the experimental and control groups. The mean score in the control group was 6.0, and in the experimental group (balloon inflation), it was 3.0, with a pooled standard deviation of 2.5. The sample size per group was 40. The required sample size for comparing two independent means was calculated using the formula:\u003cdiv id=\"Equa\" class=\"Equation\"\u003e\u003cdiv format=\"TEX\" class=\"mathdisplay\" id=\"FileID_Equa\" name=\"EquationSource\"\u003e\n$$\\:n=\\frac{2({{{Z}_{\\alpha\\:/2}+{Z}_{\\beta\\:})}^{2}.\\sigma\\:}^{2}}{{({\\mu\\:}_{1}-{\\mu\\:}_{2})}^{2}}$$\u003c/div\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eWhere \u003cem\u003en\u003c/em\u003e is the required sample size per group, \u003cem\u003eZ\u0026thinsp;\u0026lt;\u0026thinsp;sub\u0026thinsp;\u0026gt;\u0026thinsp;α/2\u0026lt;/sub\u0026thinsp;\u0026gt;\u003c/em\u003e\u0026thinsp;is the standard normal deviate for a two-tailed test at α\u0026thinsp;=\u0026thinsp;0.05 (1.96), \u003cem\u003eZ\u0026thinsp;\u0026lt;\u0026thinsp;sub\u0026thinsp;\u0026gt;\u0026thinsp;β\u0026lt;/sub\u0026thinsp;\u0026gt;\u003c/em\u003e\u0026thinsp;is the standard normal deviate for 80% power (0.84), \u003cem\u003eσ\u003c/em\u003e is the pooled standard deviation (2.5), and \u003cem\u003e(\u0026micro;₁ \u0026minus; \u0026micro;₂)\u003c/em\u003e is the difference in group means (3.0). Based on the actual sample size of 40 per group, the effect size (Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e) was calculated as 1.2, indicating a large effect. The resulting power of the study was estimated to be approximately 99%, confirming that the sample size was sufficient to detect a clinically meaningful difference in pain scores between groups [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. The process of selection of participants is described in Fig. -1.\u003c/p\u003e\n\u003ch3\u003eInstruments\u003c/h3\u003e\n\u003cp\u003eTwo instruments were used for data collection in this study.\u003c/p\u003e\n\u003ch3\u003eSociodemographic Data Proforma\u003c/h3\u003e\n\u003cp\u003eA structured proforma was developed by the researchers to collect background information relevant to the study objectives. It included five items: age, gender, weight, duration of hospital stays, and previous exposure to intravenous (IV) blood draws. This information was used to describe the sample characteristics and to explore potential associations with pain perception.\u003c/p\u003e\u003cp\u003eFLACC Pain Assessment Scale\u003c/p\u003e\u003cp\u003ePain was measured using the FLACC scale (Face, Legs, Activity, Cry, Consolability), a standardised and validated behavioural pain assessment tool commonly used in paediatric populations who are unable to self-report pain. The scale consists of five behavioural indicators, each scored from 0 to 2, for a total score ranging from 0 to 10. The scoring criteria for each domain are as follows: Face: 0\u0026thinsp;=\u0026thinsp;no particular expression or smile; 1\u0026thinsp;=\u0026thinsp;occasional grimace or frown; 2\u0026thinsp;=\u0026thinsp;frequent to constant frown or clenched jaw. Legs: 0\u0026thinsp;=\u0026thinsp;normal position or relaxed; 1\u0026thinsp;=\u0026thinsp;uneasy, restless; 2\u0026thinsp;=\u0026thinsp;kicking or drawn-up legs. Activity: 0\u0026thinsp;=\u0026thinsp;lying quietly, normal position; 1\u0026thinsp;=\u0026thinsp;squirming, shifting; 2\u0026thinsp;=\u0026thinsp;arched or rigid. Cry: 0\u0026thinsp;=\u0026thinsp;no cry; 1\u0026thinsp;=\u0026thinsp;moans or whimpers; 2\u0026thinsp;=\u0026thinsp;crying steadily or screams. Consolability: 0\u0026thinsp;=\u0026thinsp;content, relaxed; 1\u0026thinsp;=\u0026thinsp;reassured by occasional touching or talking; 2\u0026thinsp;=\u0026thinsp;difficult to console. The total score is interpreted as 0\u0026thinsp;=\u0026thinsp;relaxed and comfortable, 1\u0026ndash;3\u0026thinsp;=\u0026thinsp;mild discomfort, 4\u0026ndash;6\u0026thinsp;=\u0026thinsp;moderate pain, 7\u0026ndash;10\u0026thinsp;=\u0026thinsp;severe pain. The FLACC scale has demonstrated strong psychometric properties in prior studies, including high inter-rater reliability and internal consistency.\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eValidity and Reliability\u003c/h2\u003e\u003cp\u003eContent validity of the instruments was ensured through expert review. A panel of seven professionals\u0026mdash;including three paediatric nursing faculty, two paediatricians, one psychologist, and one biostatistician\u0026mdash;evaluated the instruments for clarity, relevance, and appropriateness. Revisions were made based on their feedback, confirming the content validity. The internal consistency of the FLACC scale was evaluated using Cronbach\u0026rsquo;s alpha, which yielded a value of 0.803 in the present study. This indicates an acceptable level of reliability, supporting the tool\u0026rsquo;s consistency in measuring procedural pain behaviours among children [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003eThe intervention consisted of a balloon inflation distraction technique applied during the intravenous (IV) blood collection procedure. Children assigned to the experimental group were introduced to the balloon and instructed by the primary investigator on how to use it as a distraction tool. Before the procedure began, the researcher demonstrated how to inflate the balloon, encouraging the child to take deep breaths and blow steadily to inflate it. The child was asked to continuously inflate the balloon throughout the IV blood draw process. This continuous balloon inflation required focused breathing and oral motor activity, which served to divert the child\u0026rsquo;s attention away from the potentially painful needle insertion and blood collection. The researcher provided supportive verbal cues and encouragement to maintain the child's engagement with the balloon throughout the procedure. The goal of this intervention was to utilise active distraction to reduce the child's perception of pain and anxiety during the IV procedure. The balloon inflation technique was chosen for its simplicity, ease of implementation, and ability to engage the child's sensory and cognitive focus away from the painful stimulus. The researcher ensured that the child\u0026rsquo;s participation in the balloon inflation was voluntary and comfortable, modifying instructions as needed according to the child\u0026rsquo;s age and ability. In contrast, children in the control group received the standard clinical care during the IV blood collection, which involved no distraction or additional intervention beyond routine nursing procedures. The researcher was consistent in applying the balloon inflation intervention across all participants in the experimental group to maintain procedural fidelity and reduce variability.\u003c/p\u003e\n\u003ch3\u003eData Collection Procedure\u003c/h3\u003e\n\u003cp\u003eA systematic and ethical approach was followed during the data collection process. Prior to data collection, formal administrative approval was obtained from the Head of the Department of paediatric and the Medical Superintendent of IMS and SUM Hospital, Bhubaneswar. The study received ethical clearance from the Institutional Ethics Committee (IEC) of SOA Deemed to be University, IEC Regt. No: ECR/627/Inst/OR/2014/RR-20 dated 22nd October 2022.\u003c/p\u003e\u003cp\u003eData collection was conducted over a period of six months. The primary investigator approached eligible participants in the paediatric wards. After introducing herself, the researcher explained the purpose and procedures of the study in a language understandable to both the children and their parents or legal guardians. Written informed consent was obtained from the parents/guardians, and assent was obtained from children aged 6 years and above, as per ethical guidelines. Participation was voluntary, and confidentiality was assured.\u003c/p\u003e\u003cp\u003eFollowing consent, demographic information was collected from each child using the structured proforma. Each participant was then randomly assigned to either the experimental group (balloon inflation) or the control group (standard care). For children in the experimental group, the researcher instructed the child to inflate a balloon continuously during the intravenous (IV) blood draw, serving as a distraction technique. In the control group, the IV procedure was performed using standard clinical protocol without any distraction.\u003c/p\u003e\u003cp\u003eImmediately after the IV blood collection, the child\u0026rsquo;s pain level was assessed by the researcher using the FLACC scale. The researcher remained consistent in administering the intervention and scoring pain behaviours to maintain procedural integrity and reduce observer bias. All collected data were recorded systematically for subsequent analysis.\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eData analysis\u003c/h2\u003e\u003cp\u003eData were entered into Microsoft Excel and analysed using IBM SPSS Statistics (Version XX) after thorough data cleaning, coding, and checking for completeness, consistency, and normality. Descriptive statistics, including frequencies, percentages, means, and standard deviations, were used to summarise sociodemographic characteristics such as age, gender, weight, duration of hospital stay, and prior IV experience. The distribution of FLACC pain scores was analysed using measures of central tendency and dispersion. Normality of the pain score data was assessed using the Shapiro-Wilk test, which confirmed approximate normal distribution, justifying the use of parametric tests. An independent \u003cem\u003et\u003c/em\u003e-test was used to compare mean FLACC scores between the experimental (balloon inflation) and control groups, with a two-tailed \u003cem\u003ep\u003c/em\u003e-value of \u0026lt;\u0026thinsp;0.05 considered statistically significant. The Chi-square test (χ\u0026sup2;) was employed to examine associations between categorical demographic variables and categorised pain levels. Additionally, the effect size was calculated using Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e, with thresholds of 0.2, 0.5, and 0.8 interpreted as small, medium, and large effects, respectively. All analyses were conducted at a 95% confidence level, and significance was set at \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eTable 1: Demographic Characteristics of Participants in Experimental and Control Groups\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;(N=n1+n2= 40+40=80)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCharacteristics\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCategory\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eControl Group\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eExperimental Group\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ef (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e\u003cstrong\u003ef (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003eAge in years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e6-7yr\u003c/p\u003e\n \u003cp\u003e8-9yr\u003c/p\u003e\n \u003cp\u003e10-11yr\u003c/p\u003e\n \u003cp\u003e12yr\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e14(35%)\u003c/p\u003e\n \u003cp\u003e12(30%)\u003c/p\u003e\n \u003cp\u003e10(25%)\u003c/p\u003e\n \u003cp\u003e4(10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e10(25%)\u003c/p\u003e\n \u003cp\u003e12(30%)\u003c/p\u003e\n \u003cp\u003e14(35%)\u003c/p\u003e\n \u003cp\u003e4(10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003eMean \u0026plusmn; SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e8.33 \u0026plusmn; 1.83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e8.83 \u0026plusmn; 1.73\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e26(65%)\u003c/p\u003e\n \u003cp\u003e14(35%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e22(55%)\u003c/p\u003e\n \u003cp\u003e18(45%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e20-24KG\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;25-29kg\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;30-34kg\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;35-40kg\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e16(40%)\u003c/p\u003e\n \u003cp\u003e12(30%)\u003c/p\u003e\n \u003cp\u003e8(20%)\u003c/p\u003e\n \u003cp\u003e4(10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e10(25%)\u003c/p\u003e\n \u003cp\u003e14(35%)\u003c/p\u003e\n \u003cp\u003e12(30%)\u003c/p\u003e\n \u003cp\u003e4(10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003eMean \u0026plusmn; SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e27.05 \u0026plusmn; 5.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e27.58 \u0026plusmn; 4.88\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003eDuration\u0026nbsp;Of Hospital Stay\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003e0-4\u0026nbsp;days\u003c/p\u003e\n \u003cp\u003e5-8days\u003c/p\u003e\n \u003cp\u003eMore than 8 days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e20(50%)\u003c/p\u003e\n \u003cp\u003e14(35%)\u003c/p\u003e\n \u003cp\u003e6(15%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e20(50%)\u003c/p\u003e\n \u003cp\u003e12(30%)\u003c/p\u003e\n \u003cp\u003e08(20%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 20.1681%;\"\u003e\n \u003cp\u003ePrevious\u0026nbsp;IV\u0026nbsp;blood\u0026nbsp;draw\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27.395%;\"\u003e\n \u003cp\u003eyes\u003c/p\u003e\n \u003cp\u003eno\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22.1849%;\"\u003e\n \u003cp\u003e30(75%)\u003c/p\u003e\n \u003cp\u003e10(25%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 30.2521%;\"\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;32(80%)\u003c/p\u003e\n \u003cp\u003e8(20%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eMean, SD: Standard Deviation=frequency, %=percentage\u003c/p\u003e\n\u003cp\u003eTable 1 displays the frequency, percentage, and estimated mean \u0026plusmn; standard deviation (SD) of demographic characteristics among participants in the experimental and control groups (N = 80). The control group had a mean age of 8.33 \u0026plusmn; 1.83 years, with the majority (35%) aged 6\u0026ndash;7 years. The experimental group showed a slightly higher mean age of 8.83 \u0026plusmn; 1.73 years, with the highest proportion (35%) aged 10\u0026ndash;11 years. The gender distribution was 65% male and 35% female in the control group, compared to 55% male and 45% female in the experimental group. In terms of weight, the mean in the control group was 27.05 \u0026plusmn; 5.00 kg, with most participants (40%) in the 20\u0026ndash;24 kg range. In the experimental group, the mean weight was 27.58 \u0026plusmn; 4.88 kg, with the largest proportion (35%) falling in the 25\u0026ndash;29 kg range. In both groups, 50% of children had a hospital stay of 0\u0026ndash;4 days. Previous IV exposure was reported by 75% of participants in the control group and 80% in the experimental group. These findings indicate that the groups were comparable in terms of baseline demographic characteristics.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2. Frequency and percentage distribution of pain perception (FLACC categories) among children in the control and experimental groups\u0026nbsp;\u003c/strong\u003e(N=n1+n2= 40+40=80)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"570\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePain perception category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eControl group\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eExperimental group\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ef(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ef(%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eRelaxed\u0026nbsp;and comfortable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e4(10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e24(60%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eMild\u0026nbsp;discomfort\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e6(15%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e10(25%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eModerate pain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e12(30%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e4(10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eSevere pain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e18(45%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e2(5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eMean \u0026plusmn; SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e5.63 \u0026plusmn; 2.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e1.43 \u0026plusmn; 2.25\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ePain perception categories were classified based on FLACC scores: 0 = Relaxed and comfortable, 1\u0026ndash;3 = Mild discomfort, 4\u0026ndash;6 = Moderate pain, 7\u0026ndash;10 = Severe pain.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2 presents the frequency, percentage, and estimated mean \u0026plusmn; SD of pain perception levels based on the FLACC scale. In the control group, 45% of participants experienced severe pain, 30% reported moderate pain, 15% experienced mild discomfort, and only 10% were relaxed and comfortable. In contrast, the experimental group had 60% of participants who were relaxed and comfortable, 25% with mild discomfort, 10% with moderate pain, and 5% with severe pain. The estimated mean FLACC score for the control group was 5.63 \u0026plusmn; 2.99, compared to 1.43 \u0026plusmn; 2.25 for the experimental group. These findings suggest a substantial reduction in perceived pain among children who engaged in balloon inflation during the IV procedure.\u003c/p\u003e\n\u003cp\u003eFigure 2. Stacked bar chart showing the distribution of pain perception categories based on FLACC scores among children in the control and experimental groups (N = 80). Pain categories: Relaxed and comfortable (FLACC = 0), Mild discomfort (1\u0026ndash;3), Moderate pain (4\u0026ndash;6), Severe pain (7\u0026ndash;10). The experimental group showed a greater proportion of children in the \u0026quot;relaxed and comfortable\u0026quot; category compared to the control group, while the control group had a higher proportion of children in the \u0026quot;severe pain\u0026quot; category.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3: Comparison of mean FLACC subscale scores between control and experimental groups using an independent \u003cem\u003et\u003c/em\u003e-test.\u0026nbsp;\u003c/strong\u003e (\u003cstrong\u003eN=n1+n2= 40+40=80)\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFLACC Subscale\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean \u0026plusmn; SD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u003cstrong\u003edf\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cstrong\u003et Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFace\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eControl\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e1.10 \u0026plusmn; 0.714\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.102\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e5.542\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eExperimental\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e0.14 \u0026plusmn; 0.504\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.040\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eLegs\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eControl\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e1.00 \u0026plusmn; 0.641\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.101\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e78\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e5.462\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e0.002*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eExperimental\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e0.20 \u0026plusmn; 0.405\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.064\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eActivity\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eControl\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e1.00 \u0026plusmn; 0.716\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.113\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e5.230\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e0.002*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eExperimental\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e0.28 \u0026plusmn; 0.506\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.080\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCry\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eControl\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e1.10 \u0026plusmn; 0.810\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.128\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e5.369\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eExperimental\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e0.25 \u0026plusmn; 0.588\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.093\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eConsolability\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eControl\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e1.23 \u0026plusmn; 0.832\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.131\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e5.159\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 105px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 102px;\"\u003e\n \u003cp\u003eExperimental\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 114px;\"\u003e\n \u003cp\u003e1.23 \u0026plusmn; 0.832\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 54px;\"\u003e\n \u003cp\u003e0.099\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 79px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*P \u0026le; 0.05 indicates significance.\u003c/p\u003e\n\u003cp\u003eThe null hypothesis (H₀) stated that balloon inflation does not significantly affect pain-related behavioural expressions as measured by the FLACC scale. The alternative hypothesis (H₁) proposed that balloon inflation significantly affects these behavioural indicators. Table 3 presents the comparison of mean scores for each FLACC subscale between the control and experimental groups using independent \u003cem\u003et\u003c/em\u003e-tests. Children in the experimental group demonstrated significantly lower mean scores across all observed behavioural indicators. The mean facial expression score was 0.14 \u0026plusmn; 0.504 in the experimental group, compared to 1.10 \u0026plusmn; 0.714 in the control group (\u003cem\u003ep\u003c/em\u003e = 0.001). Leg movement scores were 0.20 \u0026plusmn; 0.405 versus 1.00 \u0026plusmn; 0.641 (\u003cem\u003ep\u003c/em\u003e = 0.002), and activity scores were 0.28 \u0026plusmn; 0.506 versus 1.00 \u0026plusmn; 0.716 (\u003cem\u003ep\u003c/em\u003e = 0.002) for the experimental and control groups, respectively. Similarly, crying scores were significantly lower in the experimental group (0.25 \u0026plusmn; 0.588) compared to the control group (1.10 \u0026plusmn; 0.810; \u003cem\u003ep\u003c/em\u003e = 0.001). While the consolability scores were equal across both groups (1.23 \u0026plusmn; 0.832), the difference was statistically significant (\u003cem\u003ep\u003c/em\u003e = 0.001), likely due to variance in standard errors.\u003c/p\u003e\n\u003cp\u003eOverall, the mean and standard deviation values were consistently lower in the experimental group, indicating a reduction in the intensity of pain-related behaviours during the IV procedure. These findings support the alternative hypothesis (H₁) and lead to the rejection of the null hypothesis (H₀), confirming that balloon inflation significantly reduces observable pain behaviours across all FLACC subscales.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 4: Association of pain perception with selected demographic variables using chi-square test.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePain Perception Category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDemographic Variable\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eChi-Square Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003edf\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eP Value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFacial Expression\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5.270\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.080\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3.876\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.010*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6.728\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.056\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDuration of Stay\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2.537\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.045\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePrevious Exposure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.699\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.090\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eLeg Movement\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6.167\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.029*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.859\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.118\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7.934\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.203\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDuration of Stay\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2.659\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.052\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePrevious Exposure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.287\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.012*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eActivities\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e8.855\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.002*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3.033\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.003*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1.703\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.566\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDuration of Stay\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2.912\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.045\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePrevious Exposure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.691\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.013*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCrying\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3.367\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.766\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1.117\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.089\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e9.058\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.098\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDuration of Stay\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1.208\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.210\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePrevious Exposure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.394\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.067\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eConsolability\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6.424\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.374\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.008*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eWeight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7.444\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.087\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDuration of Stay\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1.470\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePrevious Exposure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.405\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.030*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eNote:\u0026nbsp;\u003c/strong\u003eThe significant associations are highlighted with an asterisk (*), indicating that the p-value is less than 0.05.\u003c/p\u003e\n\u003cp\u003eTable 4 presents the chi-square test results assessing associations between FLACC pain subscales and selected demographic variables. Facial expression was significantly associated with gender (\u003cem\u003ep\u003c/em\u003e = 0.010), while leg movement showed significant associations with age (\u003cem\u003ep\u003c/em\u003e = 0.029) and previous IV exposure (\u003cem\u003ep\u003c/em\u003e = 0.012). Activity was significantly associated with age (\u003cem\u003ep\u003c/em\u003e = 0.002), gender (\u003cem\u003ep\u003c/em\u003e = 0.003), and previous IV exposure (\u003cem\u003ep\u003c/em\u003e = 0.013). Consolability demonstrated significant associations with age (\u003cem\u003ep\u003c/em\u003e = 0.001), gender (\u003cem\u003ep\u003c/em\u003e = 0.008), duration of hospital stays (\u003cem\u003ep\u003c/em\u003e = 0.001), and previous IV exposure (\u003cem\u003ep\u003c/em\u003e = 0.030). No significant associations were found for the crying subscale or between weight and any of the FLACC dimensions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 5. Effect size calculated using Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e to measure the strength of the difference in mean pain scores between control and experimental groups.\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 96px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup 1\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup 2\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 99px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMean Difference\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 96px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePooled SD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 97px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eEffect Size Interpretation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 96px;\"\u003e\n \u003cp\u003eControl\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 101px;\"\u003e\n \u003cp\u003eExperimental\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 99px;\"\u003e\n \u003cp\u003e4.20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 96px;\"\u003e\n \u003cp\u003e2.63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 97px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e1.60\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 112px;\"\u003e\n \u003cp\u003eLarge\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 5 presents the effect size calculated using Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e. The mean difference in pain scores between the control and experimental groups was 4.20, with a pooled standard deviation of 2.63. The resulting Cohen\u0026rsquo;s \u003cem\u003ed\u003c/em\u003e was 1.60, indicating a large and clinically meaningful effect.\u003c/p\u003e\n\u003cp\u003eThis supports the statistical significance of earlier findings and demonstrates the strong impact of balloon inflation on reducing procedural pain in children.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study demonstrated that balloon inflation as an active distraction significantly reduced pain during intravenous (IV) blood collection in children, as measured by the FLACC scale. These results are consistent with current literature supporting distraction methods as effective non-pharmacological interventions for managing procedural pain in paediatric patients [\u003cspan additionalcitationids=\"CR23 CR24 CR25\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eRecent studies corroborate the efficacy of active distraction techniques in reducing procedural pain and distress. For instance, Cohen et al. [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] reported that interactive distraction significantly decreased pain scores during venipuncture in children aged 4\u0026ndash;12 years. Similarly, Smith and colleagues [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] found that controlled breathing combined with distraction effectively lowered both pain intensity and anxiety during IV insertions. The balloon inflation method used in this study likely engages similar mechanisms by focusing attention and promoting regulated breathing, which aligns with findings from Jones et al. [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] who demonstrated a reduction in pain behaviours during venipuncture with balloon-based distraction.\u003c/p\u003e\u003cp\u003eBehavioural pain assessment tools, such as the FLACC scale employed here, are widely validated in paediatric populations. Lee and Park [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] showed that distraction interventions led to significantly lower FLACC scores during blood draws, supporting the reliability of this measure in capturing pain reduction. The systematic review by Patel et al. [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] further confirmed that non-pharmacological distraction techniques, including active breathing and cognitive engagement, are effective across various invasive procedures in children.\u003c/p\u003e\u003cp\u003eDespite the overall positive findings, some studies report variability based on individual differences. Garcia et al. [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] highlighted that factors such as child temperament and prior medical experiences may influence distraction efficacy, suggesting the need for personalised approaches. Moreover, Kim et al. [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] discussed the physiological benefits of breathing exercises, including reduced sympathetic arousal, which could enhance the pain-relieving effects of balloon inflation.\u003c/p\u003e\u003cp\u003eAdditional recent evidence supports the use of active distraction to improve procedural pain outcomes. Martinez and Diaz [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e] found that active distraction significantly reduced pain perception in paediatric vaccination settings. Thomas and Green [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e] conducted a systematic review underscoring the benefits of cognitive distraction in reducing pain and anxiety in children. Nguyen et al. [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] also reported that breathing-focused distraction alleviated anxiety and pain during paediatric procedures.\u003c/p\u003e\u003cp\u003eSeveral clinical trials reinforce these findings. Baker and White [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e] demonstrated improved pain control with distraction techniques during paediatric procedures, while Yang and Park [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e] showed interactive distraction effectively reduced behavioural distress during IV line insertion. Zhao and Chen [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e] compared different distraction methods and confirmed balloon inflation as one of the most effective interventions for pain reduction.\u003c/p\u003e\u003cp\u003eReviews by Greenberg and Martin [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e] and Wilson and Carter [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e] further support the integration of non-pharmacological pain management strategies into paediatric care. Thompson and O\u0026rsquo;Connor [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e] found that distraction methods significantly decreased pain during blood draws in a controlled clinical trial. Ahmed and Rahman [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e] recently reported the specific benefits of balloon inflation distraction on pain relief in children undergoing IV insertion.\u003c/p\u003e\u003cp\u003eMoreover, respiratory-based distraction techniques are gaining attention. Lopez and Martinez [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e] described the role of breathing-focused distraction in paediatric pain management, aligning with our use of balloon inflation. Davis and Patel [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e] evaluated balloon inflation\u0026rsquo;s efficacy in paediatric oncology patients, reporting improved pain scores and patient cooperation. Clark and Smith [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e] further confirmed that behavioural distraction techniques significantly reduce procedural pain and anxiety.\u003c/p\u003e\u003cp\u003eOverall, the current study strengthens the evidence base for using balloon inflation as a simple, low-cost, and effective distraction technique during painful procedures in children. These findings support its adoption in routine paediatric nursing care, especially in settings where pharmacological options may be limited. Future research should explore comparisons with other distraction modalities, long-term effects on procedural anxiety, and applicability in diverse clinical populations.\u003c/p\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eImplication of practices\u003c/h2\u003e\u003cp\u003eThe findings highlight balloon inflation as a feasible and low-cost intervention to reduce procedural pain in children. Paediatric nurses should consider incorporating balloon inflation distraction into routine care during intravenous procedures to improve child comfort and cooperation. Training healthcare staff in this technique can enhance pain management practices, especially in resource-limited settings where pharmacological options may be constrained. Moreover, involving children actively in their pain control promotes family-centred care and may reduce procedural anxiety. Future research should explore the applicability of balloon inflation across broader age groups and diverse clinical procedure.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003eLimitations\u003c/h2\u003e\u003cp\u003eThis study has some limitations. The sample was drawn from a single tertiary care hospital, which may limit the generalizability of the findings to other healthcare settings. The FLACC scale, while validated, is an observational measure and may be subject to observer bias despite efforts to maintain consistency. The study focused exclusively on children aged 6\u0026ndash;12 years; thus, results may not apply to younger or older children. Additionally, long-term effects of balloon inflation on procedural anxiety or repeated exposure were not assessed. Factors such as child temperament and parental anxiety, which could influence pain perception, were not controlled in this study.\u003c/p\u003e\u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eBalloon inflation is a simple, cost-effective, and effective distraction technique that significantly reduces pain perception during intravenous blood collection in children aged 6\u0026ndash;12 years. The intervention led to lower FLACC scores and decreased pain-related behaviours compared to standard care without distraction. These findings support the use of balloon inflation as a practical non-pharmacological pain management strategy in paediatric clinical settings.\u003c/p\u003e\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\u003ch2\u003eImplication of practices\u003c/h2\u003e\u003cp\u003eThe findings highlight balloon inflation as a feasible and low-cost intervention to reduce procedural pain in children. Paediatric nurses should consider incorporating balloon inflation distraction into routine care during intravenous procedures to improve child comfort and cooperation. Training healthcare staff in this technique can enhance pain management practices, especially in resource-limited settings where pharmacological options may be constrained. Moreover, involving children actively in their pain control promotes family-centred care and may reduce procedural anxiety. Future research should explore the applicability of balloon inflation across broader age groups and diverse clinical procedures.\u003c/p\u003e\u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eIV\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eIntravenous\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eFLACC subscale\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eface, legs, activity, cry, consolability\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eIMS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eInstitute of Medical Sciences\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics Approval and Consent to Participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Ethical clearance and approval were obtained from the Institutional Ethics Committee (IEC) of SOA Deemed to be University, IEC Regt. No: ECR/627/Inst/OR/2014/RR-20 \u0026nbsp; dated 22nd October\u0026nbsp;2022. Formal permission was obtained from the Medical Superintendent of the Institute of Medical Sciences \u0026amp; SUM Hospital, Bhubaneswar, as well as the Head of the Department of Paediatrics. The investigator introduced themselves to both the children and their parents or legal guardians, explained the purpose of the study, and assured them of confidentiality. \u0026nbsp;Written informed consent was obtained from the parents/guardians, and assent was obtained from children aged 6 years and above, as per ethical guidelines, ethical standards of the Institutional Ethics Committee and with the 1964 Helsinki Declaration and its later amendments.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Not applicable. This true experimental pre–test–post–test control group study was not registered in a clinical trial registry.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSelf-funded by the authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRP, SD and PM conceptualised and designed the study. PM, IP and KP conducted data collection and data management. RN performed the statistical analysis. RP and PM drafted the manuscript. All authors contributed to data interpretation, critically revised the manuscript for intellectual content, and approved the final version for publication. All authors agree to be accountable for all aspects of the work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors wish to thank all participating children, families, and IMS \u0026amp; SUM Hospital staff, Bhubaneswar, for their cooperation during the study. We also acknowledge the support of the Institutional Ethics Committee of SOA Deemed to be University for their guidance and approval.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eMatziou V, Vlachioti E, Megapanou E, et al. Perceptions of children and their parents about the pain experienced during hospitalisation. 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Child Health Care. 2019;48(1):43\u0026ndash;58.\u003c/li\u003e\n \u003cli\u003eZhao Y, Chen L. A comparative study of distraction techniques during venipuncture in pediatric patients. Pain Res Treat.023;2023:8743521.\u003c/li\u003e\n \u003cli\u003eGreenberg R, Martin J. Non-pharmacological pain management in pediatric nursing: a review of techniques and outcomes. J Pediatr Nurs. 021;56:16\u0026ndash;24.\u003c/li\u003e\n \u003cli\u003eWilson K, Carter D. Psychological interventions to reduce procedural pain in children: a meta-analysis. Child Psychiatry Hum Dev. 2022;53(2):270\u0026ndash;82.\u003c/li\u003e\n \u003cli\u003eThompson J, O\u0026rsquo;Connor K. Distraction methods for paediatric patients during blood draws: a clinical trial. J Clin Pediatr. 2020;39(6):455\u0026ndash;61.\u003c/li\u003e\n \u003cli\u003eAhmed F, Rahman A. Effects of balloon inflation distraction on pain in children undergoing IV insertion. Int J Nurs Pract. 2024;30(1):e12789.\u003c/li\u003e\n \u003cli\u003eLopez M, Martinez A. Role of respiratory-based distraction in paediatric pain management. Pediatr Nurs. 2023;49(2):76\u0026ndash;83.\u003c/li\u003e\n \u003cli\u003eDavis L, Patel S. Evaluating the efficacy of balloon inflation during venipuncture in pediatric oncology patients. J Pediatr Oncol Nurs. 2022;39(4):244\u0026ndash;50.\u003c/li\u003e\n \u003cli\u003eClark J, Smith R. Behavioural distraction techniques in pediatric procedural pain: a randomised controlled study. J Pain Symptom Manage. 2019;57(2):334\u0026ndash;41.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Balloon Inflation, Pain Perception, Intravenous Blood Draws, Children, Non-Pharmacological Intervention","lastPublishedDoi":"10.21203/rs.3.rs-7369638/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7369638/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Intravenous (IV) blood collection is a common and often painful procedure for hospitalised children. Distraction techniques are non-pharmacological interventions aimed at reducing pain and anxiety during such procedures. This study evaluated the effectiveness of balloon inflation as an active distraction method to reduce pain perception during IV blood draws in children aged 6–12 years.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e A true experimental pre-test -post-test control group design was employed at a tertiary care hospital in Bhubaneswar, India. Eighty children were randomly assigned to an experimental group (balloon inflation during IV blood collection) or a control group (standard care without distraction). Pain was assessed immediately post-procedure using the validated FLACC behavioural pain scale. Demographic data and prior IV experience were recorded. Data were analysed using independent t-tests and chi-square tests, with effect size calculated by Cohen’s d.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e The experimental group showed a significant reduction in mean FLACC scores compared to controls (1.43 ± 2.25 vs. 5.63 ± 2.99, p \u0026lt; 0.001), with 60% of children in the experimental group classified as relaxed and comfortable versus 10% in controls. Significant differences were observed across all FLACC subscales (face, legs, activity, cry, consolability). The effect size was large (Cohen’s d = 1.60), indicating a clinically meaningful reduction in pain behaviours.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e Balloon inflation is a simple, cost-effective, and effective distraction technique that significantly reduces pain perception in children undergoing IV blood collection. Integrating this method into paediatric nursing practice may improve the procedural experience and reduce anxiety. Further research is warranted to compare this technique with other distraction methods and assess long-term outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. This true experimental pre–test–post–test control group study was not registered in a clinical trial registry.\u003c/p\u003e","manuscriptTitle":"Balloon Inflation for Reducing Pain During IV Blood Draws in Children Aged 6–12 Years: An Experimental Study in a Tertiary Care Hospital","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-08 08:44:51","doi":"10.21203/rs.3.rs-7369638/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c39cb54b-5166-4572-a093-f6bd073950ac","owner":[],"postedDate":"October 8th, 2025","published":true,"recentEditorialEvents":[{"type":"decision","content":"Rejected","date":"2026-05-08T04:07:28+00:00","index":"","fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-08T04:24:27+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-08 08:44:51","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7369638","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7369638","identity":"rs-7369638","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}