Impact of Virtual Reality on Pain and Anxiety During Intravenous Cannulation Procedures Among Thalassemia Patients in the UAE: A Crossover Clinical Trial

Impact of Virtual Reality on Pain and Anxiety During Intravenous Cannulation Procedures Among Thalassemia Patients in the UAE: A Crossover Clinical Trial | 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 Impact of Virtual Reality on Pain and Anxiety During Intravenous Cannulation Procedures Among Thalassemia Patients in the UAE: A Crossover Clinical Trial Sameer Asim Khan, Fawaz Shefeek Mohammed, Humza Iqbal Rathore, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7539274/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: Patients with β-Thalassemia frequently experience repeated hospital visits and cannulations, leading to chronic pain and anxiety, which adversely affect their quality of life. Virtual Reality (VR) has been shown the efficacity to manage the pain and anxiety associated with medical procedures. The purpose of this study was to evaluate the effects of therapeutic VR on pain, anxiety, fatigue, satisfaction, and boredom during intravenous (IV) cannulations in comparison to standard of care (SOC). Results: A total of 115 patients completed the SOC session and 111 patients completed the VR session. Overall, 82% of the patients were older than 18 years, and 51% were male. The mean anxiety score was significantly lower in VR group 2.24 (±2.6) than in SOC 2.92 (±2.3), (p=0.02). Similar to the anxiety score, the fatigue score was significantly lower in VR group 1.67 (±1.3) vs 2.65 (±2.2) in SOC group (p=0.01). No side effects were reported in relation to the VR intervention. Conclusions: The usage of VR for the intervention is feasible, safe, and well-tolerated by over 90% of thalassemia patients. VR effectively reduces anxiety and fatigue during cannulations for thalassemia patients. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT07099196, identifier: NCT07099196, registered 2025-07-05. This trial was registered retrospectively. Virtual reality Pain Anxiety Medical hypnosis Intravenous cannulation Thalassemia UAE Crossover clinical trial Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Thalassemia is an inherited blood disorder characterized by reduced hemoglobin production, which limits oxygen transport in the body. It was estimated that there were approximately 399 million thalassemia carriers across the world in 2019 [ 1 ]. Hemoglobinopathies are among the most prevalent monogenic disorders in the United Arab Emirates (UAE), particularly among UAE nationals, with an 8.5% prevalence of β-globin defects [ 2 – 3 ]. The severity of these mutations poses a significant health burden [ 4 ]. Long-term management of transfusion-dependent β-thalassemia (TDT) necessitates specialized, multidisciplinary care, which becomes increasingly costly as patients age [ 5 – 6 ]. TDT patients endure numerous stressors including frequent treatments such as blood draws, chelation therapy, and transfusions [ 7 ]. The cumulative impact of the disease’s prognosis, treatment side effects, travel to specialized centers, pain, and anxiety contribute to a significantly reduced quality of life. Repeated invasive procedures, especially in childhood, can lead to adverse psychological effects, including heightened anxiety, behavioral changes, and needle phobia [ 8 ]. Moreover, routine medical procedures can trigger adverse emotional responses or trauma, particularly in patients with chronic conditions who require frequent vascular access [ 9 ]. For this reason, nurses and healthcare providers must implement specific interventions to mitigate the cumulative psychological impact and enhance patients’ comfort during such procedures [ 10 ]. Research to date has shown that active distractions can be more effective than passive ones in multiple healthcare disciplines such as pediatrics and oncology [ 11 ]. Virtual reality (VR) is a technology that enables patients to be projected, via a computer system, into an immersive 3D virtual world. Immersion in VR creates a strong sense of ‘presence,’ in which patients feel engaged in the simulated environment as if it were real. This specificity gives VR a highly immersive and distracting capacity. For cancer patients, VR has been shown to be more effective than other forms of distraction in relieving anxiety, depression, and fatigue during chemotherapy [ 12 ]. In recent years, the number of studies investigating the use of VR as a non-pharmacological method of reducing pain and anxiety has grown rapidly. In this regard, VR effectively diverts the patient's attention away from the source of pain, thereby diminishing his or her conscious perception of it [ 13 – 14 ]. Numerous studies have confirmed this analgesic effect of VR across various interventions and patient populations, including procedures like wound care [ 15 – 16 ], needle insertion in children [ 17 – 18 ], perioperative management [ 19 – 20 ], and chronic back pain relief [ 21 ]. Research indicates that VR can be implemented in healthcare settings with relatively low costs [ 22 ] and has demonstrated superior pain reduction for patients compared to standard care during procedures like IV placements [ 23 ]. Notably, VR's role in minimizing pain among patients undergoing routine medical interventions highlights its potential as a non-pharmacological pain management strategy. In addition to alleviating pain, VR interventions have been found to reduce symptoms of acute anxiety in patients during medical procedures [ 24 ]. This is particularly important, as anxiety can exacerbate pain perception, creating a cycle where pain and anxiety reinforce each other [ 25 ]. For example, Gold et. al found that children receiving standard care during IV placements reported much higher levels of affective pain compared to those who used VR, underscoring the impact of VR in managing both pain and anxiety [ 23 ]. The concept of anxiety sensitivity—an individual’s heightened fear of anxiety-related sensations—further highlights the relevance of addressing anxiety to improve pain management outcomes [ 26 ]. While existing research supports the effectiveness of VR for pain and anxiety reduction, most studies have focused on small sample sizes and limited settings, such as emergency departments and outpatient clinics [ 27 – 29 ]. Findings from these studies demonstrate a statistically significant reduction in perceived pain, but similar studies are needed in other clinical contexts, particularly for chronic patients who undergo repeated procedures. As such, exploring VR's potential for improving procedural comfort in thalassemia patients presents an opportunity to expand its applicability and provide clinically relevant data for broader implementation in healthcare. Methods Aims & Objectives The primary aim of this study was to assess whether VR has a greater therapeutic impact on patient anxiety and pain perception compared to the standard of care during intravenous cannulation procedures among thalassemia patients. Secondary objectives included evaluating the effects of VR on patient satisfaction, fatigue and boredom. This would allow us to draw a conclusion on the effectiveness of virtual reality as an adjuvant medical device during the intravenous cannulation procedure. We therefore hypothesized that the use of virtual reality for thalassemia patients would have a positive impact on reducing pain, anxiety, boredom, and fatigue with lower reported VAS scores compared to SOC. We also expected to see improved overall experience during the intravenous cannulation procedure with higher patient satisfaction scores compared to the SOC. Study design: This was an interventional, cross-over, single-center study conducted at the Dubai Thalassemia Center, comparing effects in pain and anxiety using therapeutic virtual reality intervention and standard of care during intravenous cannulation for thalassemia patients (retrospective Clinical Trial Registration: https://clinicaltrials.gov/study/NCT07099196 , identifier: NCT07099196). The study was conducted between May and September of 2024 and recruited 115 patients in total. Adherence to the Consolidated Standards of Reporting Trials statement (CONSORT) was maintained in reporting this study [ 30 ]. The study was approved by the MBRU Student and Resident Research Ethics Subcommittee and Dubai Scientific Research Ethics Committee (MBRU IRB-2024-80). Participants: Inclusion criteria: Patients with a diagnosis of thalassemia Thalassemia patients undergoing intravenous cannulation procedure Patients aged > 7 years (male, female, adult, pediatrics, national and non-national) at the Dubai Thalassemia Center Exclusion criteria: Pregnant or nursing women Patients of legal age but subject to legal protection measures or unable to express their consent Patients suffering from uncontrolled epilepsy Patients with visual or auditory disorders Patients suffering from claustrophobia or motion sickness Patients with face infections Patients with dissociative psychiatric pathologies and/or autism Patients were screened at the Dubai Thalassemia Center during routine consultations, where the investigator present explained the study's objectives to the patient. After consulting the patients' medical records and ensuring that there were no exclusion criteria and that the inclusion criteria were met, the investigators introduced themselves to the patients and their families, offering them the chance to take part in the study. The investigators then explained to patients that they were eligible for this study and described the study’s aims. Written and signed consent was obtained from adult patients and guardians of minors with an informed consent form. Additionally, patients under 18 years of age were provided with an assent form with simplified information about the study. Investigators took the time to answer the patient's questions about the study's progress, expected results, and anticipated benefits. No financial compensation was paid to participants in this study. Participation in this study had no financial consequences for the participant, nor on his/her health insurance, as this was part of the routine care and consultation for the patient. Participants were free to withdraw from the study at any time during the procedure. In the event of withdrawal, the data collected up to that point was analyzed, so as not to compromise the value of the study. Regardless of withdrawal, the anonymity of all patient data was maintained. Interventions Patients benefited from the standard of care during their first visit, then utilized the VR intervention during the cannulation in their second visit and finally, another VR session in the third (Fig. 1 ). We used therapeutic immersions curated by the France-based company Healthy Mind, with various environments, including elements of medical hypnosis and breathing exercises, tailored for use in invasive procedures. For each patient, the overall duration of the study was 6–8 weeks to complete all three visits, considering the 3–4-week interval between their scheduled appointments at the thalassemia center. It should be noted that appointments were postponed if the patient did not complete the routine cross-matching test prior to the intravenous cannulation procedure or did not show up for their appointments. Outcomes All participants completed questionnaires after the intravenous cannulation procedure during Visits 1, 2 and 3 (see Supplementary File 1). The Visual Analogue Scale (VAS) was used to assess both primary (pain and anxiety) and secondary (fatigue and boredom) objectives (refer to Fig. 2 .), collecting self-reported data during the three visits. Patient satisfaction with using therapeutic VR during the cannulation procedure was also measured in the questionnaire (refer to Fig. 3 .), specifically their satisfaction with the immersive environment, breathing exercises and overall feeling of relaxation, from a very dissatisfied to very satisfied scale. We also used physiological constants such as Heart Rate (measured in beats per minute (BPM)) and Blood Pressure (measured in millimeters of mercury (mmHg)), after the SOC and VR procedure, to provide more objective measures. Statistical analysis Size Calculation Given the exploratory nature of the trial, we determined sample size based on the number of potential orders of VR sessions (18 in total). To ensure balanced representation, we planned for at least two participants per order (36 minimum). To account for attrition and missing data, 100 patients were targeted, with 80% power to detect a clinically significant difference of greater than 2, with an alpha threshold of 0.05. Presentation of data and analysis Quantitative data was presented with either the mean and standard deviation or median and quartiles, depending on the distribution of the data. For qualitative data, we used n for the number of data points and frequency as a percentage. All VR sessions were analyzed on an intent-to-treat basis. Primary endpoint Data for heart rate and blood pressure were calculated as mean ± SD or median and interquartile range (IQR). These calculations were conducted in line with the Kolmogorov–Smirnov test. Categorical variables were summarized as frequencies and percentages. The student’s paired t-test or the Wilcoxon signed-rank test were used to compare variables between the SOC and VR sessions. To explore independent predictors of outcomes, we performed stepwise linear regression modeling. Secondary endpoints and safety and feasibility Any form of cybersickness (vertigo, nausea, or vomiting associated with visuospatial changes) was reported by patients if present after every VR session. The ease of use of the devices was also assessed by using a numeric rating scale (NRS) (where 0 was extremely difficult to use and 10 was the easiest possible thing to use). Any incidents occurring during the sessions were also recorded and investigated by the team. Statistical methods were adapted from previously published approaches to VR interventions in clinical trials [ 31 , 32 ]. Results During the study period, 180 patients were admitted to the Dubai Thalassemia Center. Of these, 65 patients were excluded due to not meeting inclusion criteria, declining to participate, or screening failure, leaving 115 patients who were enrolled and included in the analysis (Fig. 4 ). All 115 enrolled patients completed at least one standard-of-care (SOC) session, and 111 of these patients also completed at least one virtual reality (VR) intervention session in addition to SOC. Among those 111 patients, 70 completed all three scheduled visits. The remaining 41 patients did not complete their second VR intervention session for reasons such as missed appointments or fear in the case of pediatric patients. Overall, 82% of the patients were older than 18 years, and 51% were male. The mean age of the participants was 26 years. Table 1 presents the demographic and clinical characteristics of the study population. Table 1 Characteristics All VR Group SOC Group Age (yr) Gender (F/M) BMI (kg.m − 2) Pulse Arterial pression (Systolic) Arterial pression (Diastolic) 26 [9–46] (51%) / (49%) 22 [13–45] 95 112 (87–160) 77 (65–98) 87 112 (87–144) 81 (77–94) 97 105 (90–160) 78 (65–98) The mean anxiety score was significantly lower in VR group 2.24 (± 2.6) than in SOC 2.92 (± 2.3), (p = 0.02). Similar to the anxiety score, the fatigue score was significantly lower in VR group 1.67 (± 1.3) vs 2.65 (± 2.2) in SOC group (p = 0.01). A similar reduction was observed in boredom score with the VR group 1.72 (± 1.4) vs 2.67 (± 2.2) in SOC Group (p = 0.035) However, the mean pain score was not significantly different as compared to VR group 2.23 (± 1.8) and 2.89 (± 2.1) for SOC Group (p = 0.07). Likewise, the heart rate was not significantly different in VR group 62 bpm vs 65 bpm in SOC group. Satisfaction and Safety Overall patient satisfaction was systematically better in VR group despite not being statistically significant (90% in VR vs. 85% in SOC; p = 0.237). Additionally, no VR-related side effects were reported, and tolerability was excellent. Discussion The main findings of this cross-over study are that using virtual reality as adjuvant electronic relaxation devices is feasible, safe, and well tolerated in more than 90% of thalassemia patients undergoing routine intravenous cannulations or TDT procedures. Our finding indicates that while using VR, anxiety and fatigue were found to be significantly lower compared to SOC sessions. This result is reinforced by a significantly greater decrease in fatigue and boredom scores in the VR group compared to standard of care, which is especially important since the intervention has to repeated for life. Other parameters, such as pain and patient satisfaction, showed no statistically significant differences between VR usage and SOC sessions. This can be explained by the low baseline pain level and patients who are accustomed to the intervention. On the other hand, the overall patient satisfaction score was higher with VR but the difference did not reach statistical significance. Previous studies have shown compelling evidence for the efficacy of VR as a distraction tool to reduce pain in invasive procedures both overall and specifically in pediatric patients [ 13 , 17 – 18 , 33 ]. Using audio hypnosis along with VR was also found to be effective in reducing pain unpleasantness by 25% more than just VR [ 34 ]. Anxiety was found to be significantly reduced from 7.2 ± 3.3 pre-intervention to 4.6 ± 3.0 post-intervention on the Hospital Anxiety and Depression (HAD) Scale while using VR during gynecological surgeries by Chan et al [ 35 ]. Gold and Mahrer found a reduction in pain and anxiety using VR in blood draws, with a greater reduction in anxiety in those with higher reported anxiety levels [ 18 ]. Based on prior literature, it can be observed that reported fear surrounding needles is considerably higher in pediatric patients [ 36 ], creating a greater opportunity for reduction in parameters such as anxiety in this population, which only comprised of around 18% of our study sample. With more naive or pediatric patients, greater distress could have been reported in SOC sessions and potentially greater reductions in these measures with therapeutic VR. A systematic review and meta-analysis conducted by Gao et al included data from 27 studies and found a significant reduction in pain, anxiety, and fear in pediatric patients undergoing puncture related procedures as compared to the SOC and to other distraction methods [ 37 ], highlighting the intervention’s proven efficacy. A literature review was also carried out by Addab et al, which illustrated VR’s effectiveness in reducing pain and anxiety in use cases such as burn wound care, dental, and needle-related procedures [ 38 ]. Interestingly, another systematic review and meta-analysis conducted by Czech et al including 7 studies found a significant reduction in pain, but no statistically significant reduction in fear or anxiety, or any improvement in satisfaction overall [ 39 ]. These results contrasted our findings of reduced anxiety as opposed to pain but were similar when looking at the satisfaction with the intervention. The findings of this study hold significant implications for improving patient care during cannulations and similar invasive procedures, particularly in patients requiring frequent interventions, such as those with hemoglobinopathies. Anxiety and fear, especially surrounding needles, are significant in pediatric populations [ 36 ] and therapeutic VR provides an option for their management. With the prevalence of haemoglobinopathies in the region [ 18 ], invasive procedures involving needles are not uncommon and create a serious burden for the UAE and surrounding nations. VR can be used in addition to traditional management techniques for pain, anxiety, fatigue, and boredom to further enhance patient experience during invasive procedures and alleviate long-term psychological effects of these symptoms on patients’ lives. The primary strength of our study is being, based on our research, the first use of therapeutic VR for a study in the region and being tailored to the UAE population, specifically those with haemoglobinopathies requiring cannulations. Due to the prevalence of haemoglobinopathies in the region [ 18 ] and around 399 million carriers of thalassemia trait in the world [ 1 ], these findings are particularly impactful for the local population. Though found to be statistically insignificant upon analysis, another strength of our study was the use of physiological constants to gain an objective angle to our data. Heart rate and blood pressure measurements were collected after the cannulation procedure to determine any stress responses as they were carried out. A drawback of our study is the limited overall pain, anxiety, fatigue, and boredom experienced by the sample population. With all mean reported values being relatively low on the VAS, discomfort was minimal due to the chronic nature of the participants’ conditions and repeated cannulations experienced throughout their lives. The procedure being relatively short (3–5 minutes) reduces the perception of boredom during the procedure, and more tedious or painful procedures could have shown higher scores or greater differences in these parameters. Additionally, as opposed to a modified VAS scale, using the Hospital Anxiety and Depression Scale could have been more appropriate to assess anxiety, as was done by Chan et al [ 27 ]. An even distribution of male and female participants allows application to both populations, but generalizability of this study may be limited to those requiring routine invasive procedures such as individuals with haemoglobinopathies undergoing routine cannulations. In order to further validate the use of therapeutic VR for issues such as pain, anxiety, boredom, and fatigue, a similar study could be carried out with other distractive techniques used as a control against VR as was carried out by Erdogan et al [ 13 ]. Exploring other use cases with higher reported discomfort (pain, anxiety, fatigue, or boredom) such as chemotherapy may also be of value to yield greater benefit from the intervention and in turn, more significant results. Furthermore, data for other parameters such as skin conductance or eye tracking could be gathered in future works for a less subjective approach which relied on self-reported data. A study with exclusively naive or pediatric patients would likely provide more benefit to patients as they have not had as much time to become accustomed to the cannulation procedure as long-time patients and tend to have greater anxiety and/or pain with regards to the cannulation procedure. Conclusion Therapeutic VR has been shown to be effective as a distraction tool in reducing anxiety and fatigue in cannulations for chronic patients and shows promise for other use cases based on previous literature, especially in pediatric and potentially naive patients. Future research should focus on more distressing use cases and other objective outcome measures to fully elucidate the scope of VR’s benefits in healthcare settings. Abbreviations BPM Beats Per Minute CONSORT Consolidated Standards of Reporting Trials HAD Hospital, Anxiety and Depression IV Intravenous MBRU Mohammed Bin Rashid University SOC Standard of Care TDT Thalassemia Dependent Transfusions UAE United Arab Emirates VAS Visual Analogue Scale VR Virtual Reality mmHg Millimeters Per Mercury Declarations Ethics approval and consent to participate This study was approved by the MBRU Student and Resident Research Ethics Subcommittee and Dubai Scientific Research Ethics Committee (MBRU IRB-2024-80) and was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrolment. For patients aged 18 and below, written informed consent was provided to the parents/legal guardians, in addition to the assent form provided to the patient. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. Funding This work was supported by Dubai Health. The funders had no role in study design, data collection, analysis, interpretation of data, or in writing the manuscript. Author Contribution YH conceived and designed the study. SAK, FSM, and HIR contributed to study design, data collection, analysis, and drafting of the manuscript. FA, AS, and BA facilitated patient recruitment and site coordination. All authors reviewed, revised, and approved the final manuscript. Acknowledgement We would like to sincerely thank the nursing team at the Dubai Thalassemia Center for their invaluable support, and the Research Methods faculty at MBRU for their guidance throughout this project. 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Supplementary Files SupplementaryFile1StudyQuestionnaire.pdf 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7539274","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":518106318,"identity":"7f18346c-c121-4830-8c84-484d383af770","order_by":0,"name":"Sameer Asim Khan","email":"data:image/png;base64,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","orcid":"","institution":"Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai Health","correspondingAuthor":true,"prefix":"","firstName":"Sameer","middleName":"Asim","lastName":"Khan","suffix":""},{"id":518106319,"identity":"84429289-f35e-4d4e-9222-3c7079bc14b4","order_by":1,"name":"Fawaz Shefeek Mohammed","email":"","orcid":"","institution":"Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai Health","correspondingAuthor":false,"prefix":"","firstName":"Fawaz","middleName":"Shefeek","lastName":"Mohammed","suffix":""},{"id":518106320,"identity":"da9d1fc6-a73a-45ae-9087-99c5c57dcfe4","order_by":2,"name":"Humza Iqbal Rathore","email":"","orcid":"","institution":"Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai Health","correspondingAuthor":false,"prefix":"","firstName":"Humza","middleName":"Iqbal","lastName":"Rathore","suffix":""},{"id":518106321,"identity":"c62d64e3-5fe0-4f5f-86ac-2e2fa7e74406","order_by":3,"name":"Ahmed Soliman","email":"","orcid":"","institution":"Dubai Health","correspondingAuthor":false,"prefix":"","firstName":"Ahmed","middleName":"","lastName":"Soliman","suffix":""},{"id":518106322,"identity":"fa159a3c-58e8-463e-ad91-d5f033404f88","order_by":4,"name":"Bushra Alfugair","email":"","orcid":"","institution":"Dubai 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08:29:33","extension":"html","order_by":15,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":114060,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/22b64f18a0dcb7142c830466.html"},{"id":91967457,"identity":"ecc8842b-79d1-4710-8956-eddb8f6ad185","added_by":"auto","created_at":"2025-09-23 08:37:33","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":967158,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eA: VR headset being used by a patient during a cannulation. B: Image observed by a patient in the VR immersion during the Underwater World environment designed by Healthy-Mind VR®.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/1876b545d15fac12e4fe97f9.png"},{"id":91967454,"identity":"5c4c031a-eb03-4c06-8dd2-9d885b2ecbd1","added_by":"auto","created_at":"2025-09-23 08:37:33","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":117345,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe VAS parameters used in the study to assess pain, anxiety, fatigue, and boredom.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/01b7cac0cc1ff6f40fbc6236.png"},{"id":91966717,"identity":"86b5d089-7d6f-4721-8560-3d552cf63443","added_by":"auto","created_at":"2025-09-23 08:29:33","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":62941,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe satisfaction scale used in the study to assess patient satisfaction.\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/6c1c9740b644b2cbf673526d.png"},{"id":91968564,"identity":"47675158-41fd-4985-8481-ab1ae480b812","added_by":"auto","created_at":"2025-09-23 08:45:33","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":39061,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe study flow chart\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/d71735951933373901881cb0.png"},{"id":91966723,"identity":"a865758a-7efe-4248-bdd6-6ef5b0667b79","added_by":"auto","created_at":"2025-09-23 08:29:33","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":12171,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of anxiety, pain, fatigue and boredom\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/b36967b21302b2ea36447e17.png"},{"id":103019091,"identity":"6a01b268-3f95-4c64-b0f1-9d80ce2f6c3e","added_by":"auto","created_at":"2026-02-19 17:26:08","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2290265,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/2b8384c6-4986-41ae-aec7-54c7c7b548f1.pdf"},{"id":91966725,"identity":"15bd2f52-a58e-4f18-a40b-d4420f1efb60","added_by":"auto","created_at":"2025-09-23 08:29:33","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":163147,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryFile1StudyQuestionnaire.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7539274/v1/a5910a334cebae91b389892c.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Impact of Virtual Reality on Pain and Anxiety During Intravenous Cannulation Procedures Among Thalassemia Patients in the UAE: A Crossover Clinical Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThalassemia is an inherited blood disorder characterized by reduced hemoglobin production, which limits oxygen transport in the body. It was estimated that there were approximately 399\u0026nbsp;million thalassemia carriers across the world in 2019 [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Hemoglobinopathies are among the most prevalent monogenic disorders in the United Arab Emirates (UAE), particularly among UAE nationals, with an 8.5% prevalence of β-globin defects [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. The severity of these mutations poses a significant health burden [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eLong-term management of transfusion-dependent β-thalassemia (TDT) necessitates specialized, multidisciplinary care, which becomes increasingly costly as patients age [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. TDT patients endure numerous stressors including frequent treatments such as blood draws, chelation therapy, and transfusions [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The cumulative impact of the disease\u0026rsquo;s prognosis, treatment side effects, travel to specialized centers, pain, and anxiety contribute to a significantly reduced quality of life. Repeated invasive procedures, especially in childhood, can lead to adverse psychological effects, including heightened anxiety, behavioral changes, and needle phobia [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Moreover, routine medical procedures can trigger adverse emotional responses or trauma, particularly in patients with chronic conditions who require frequent vascular access [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. For this reason, nurses and healthcare providers must implement specific interventions to mitigate the cumulative psychological impact and enhance patients\u0026rsquo; comfort during such procedures [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eResearch to date has shown that active distractions can be more effective than passive ones in multiple healthcare disciplines such as pediatrics and oncology [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Virtual reality (VR) is a technology that enables patients to be projected, via a computer system, into an immersive 3D virtual world. Immersion in VR creates a strong sense of \u0026lsquo;presence,\u0026rsquo; in which patients feel engaged in the simulated environment as if it were real. This specificity gives VR a highly immersive and distracting capacity. For cancer patients, VR has been shown to be more effective than other forms of distraction in relieving anxiety, depression, and fatigue during chemotherapy [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn recent years, the number of studies investigating the use of VR as a non-pharmacological method of reducing pain and anxiety has grown rapidly. In this regard, VR effectively diverts the patient's attention away from the source of pain, thereby diminishing his or her conscious perception of it [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Numerous studies have confirmed this analgesic effect of VR across various interventions and patient populations, including procedures like wound care [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], needle insertion in children [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], perioperative management [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], and chronic back pain relief [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eResearch indicates that VR can be implemented in healthcare settings with relatively low costs [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] and has demonstrated superior pain reduction for patients compared to standard care during procedures like IV placements [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Notably, VR's role in minimizing pain among patients undergoing routine medical interventions highlights its potential as a non-pharmacological pain management strategy.\u003c/p\u003e\u003cp\u003eIn addition to alleviating pain, VR interventions have been found to reduce symptoms of acute anxiety in patients during medical procedures [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. This is particularly important, as anxiety can exacerbate pain perception, creating a cycle where pain and anxiety reinforce each other [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. For example, Gold et. al found that children receiving standard care during IV placements reported much higher levels of affective pain compared to those who used VR, underscoring the impact of VR in managing both pain and anxiety [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The concept of anxiety sensitivity\u0026mdash;an individual\u0026rsquo;s heightened fear of anxiety-related sensations\u0026mdash;further highlights the relevance of addressing anxiety to improve pain management outcomes [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eWhile existing research supports the effectiveness of VR for pain and anxiety reduction, most studies have focused on small sample sizes and limited settings, such as emergency departments and outpatient clinics [\u003cspan additionalcitationids=\"CR28\" citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Findings from these studies demonstrate a statistically significant reduction in perceived pain, but similar studies are needed in other clinical contexts, particularly for chronic patients who undergo repeated procedures. As such, exploring VR's potential for improving procedural comfort in thalassemia patients presents an opportunity to expand its applicability and provide clinically relevant data for broader implementation in healthcare.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n\u003ch2\u003eAims \u0026amp; Objectives\u003c/h2\u003e\n\u003cp\u003eThe primary aim of this study was to assess whether VR has a greater therapeutic impact on patient anxiety and pain perception compared to the standard of care during intravenous cannulation procedures among thalassemia patients. Secondary objectives included evaluating the effects of VR on patient satisfaction, fatigue and boredom. This would allow us to draw a conclusion on the effectiveness of virtual reality as an adjuvant medical device during the intravenous cannulation procedure.\u003c/p\u003e\n\u003cp\u003eWe therefore hypothesized that the use of virtual reality for thalassemia patients would have a positive impact on reducing pain, anxiety, boredom, and fatigue with lower reported VAS scores compared to SOC. We also expected to see improved overall experience during the intravenous cannulation procedure with higher patient satisfaction scores compared to the SOC.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eStudy design:\u003c/h3\u003e\n\u003cp\u003eThis was an interventional, cross-over, single-center study conducted at the Dubai Thalassemia Center, comparing effects in pain and anxiety using therapeutic virtual reality intervention and standard of care during intravenous cannulation for thalassemia patients (retrospective Clinical Trial Registration: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://clinicaltrials.gov/study/NCT07099196\u003c/span\u003e\u003c/span\u003e, identifier: NCT07099196). The study was conducted between May and September of 2024 and recruited 115 patients in total. Adherence to the Consolidated Standards of Reporting Trials statement (CONSORT) was maintained in reporting this study [\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e]. The study was approved by the MBRU Student and Resident Research Ethics Subcommittee and Dubai Scientific Research Ethics Committee (MBRU IRB-2024-80).\u003c/p\u003e\n\u003ch3\u003eParticipants:\u003c/h3\u003e\n\u003cp\u003eInclusion criteria:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003ePatients with a diagnosis of thalassemia\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThalassemia patients undergoing intravenous cannulation procedure\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients aged\u0026thinsp;\u0026gt;\u0026thinsp;7 years (male, female, adult, pediatrics, national and non-national) at the Dubai Thalassemia Center\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eExclusion criteria:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003ePregnant or nursing women\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients of legal age but subject to legal protection measures or unable to express their consent\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients suffering from uncontrolled epilepsy\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients with visual or auditory disorders\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients suffering from claustrophobia or motion sickness\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients with face infections\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients with dissociative psychiatric pathologies and/or autism\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003ePatients were screened at the Dubai Thalassemia Center during routine consultations, where the investigator present explained the study's objectives to the patient.\u003c/p\u003e\n\u003cp\u003eAfter consulting the patients' medical records and ensuring that there were no exclusion criteria and that the inclusion criteria were met, the investigators introduced themselves to the patients and their families, offering them the chance to take part in the study. The investigators then explained to patients that they were eligible for this study and described the study\u0026rsquo;s aims.\u003c/p\u003e\n\u003cp\u003eWritten and signed consent was obtained from adult patients and guardians of minors with an informed consent form. Additionally, patients under 18 years of age were provided with an assent form with simplified information about the study. Investigators took the time to answer the patient's questions about the study's progress, expected results, and anticipated benefits.\u003c/p\u003e\n\u003cp\u003eNo financial compensation was paid to participants in this study. Participation in this study had no financial consequences for the participant, nor on his/her health insurance, as this was part of the routine care and consultation for the patient.\u003c/p\u003e\n\u003cp\u003eParticipants were free to withdraw from the study at any time during the procedure. In the event of withdrawal, the data collected up to that point was analyzed, so as not to compromise the value of the study. Regardless of withdrawal, the anonymity of all patient data was maintained.\u003c/p\u003e\n\u003ch3\u003eInterventions\u003c/h3\u003e\n\u003cp\u003ePatients benefited from the standard of care during their first visit, then utilized the VR intervention during the cannulation in their second visit and finally, another VR session in the third (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eWe used therapeutic immersions curated by the France-based company Healthy Mind, with various environments, including elements of medical hypnosis and breathing exercises, tailored for use in invasive procedures.\u003c/p\u003e\n\u003cp\u003eFor each patient, the overall duration of the study was 6\u0026ndash;8 weeks to complete all three visits, considering the 3\u0026ndash;4-week interval between their scheduled appointments at the thalassemia center. It should be noted that appointments were postponed if the patient did not complete the routine cross-matching test prior to the intravenous cannulation procedure or did not show up for their appointments.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eAll participants completed questionnaires after the intravenous cannulation procedure during Visits 1, 2 and 3 (see Supplementary File 1). The Visual Analogue Scale (VAS) was used to assess both primary (pain and anxiety) and secondary (fatigue and boredom) objectives (refer to Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.), collecting self-reported data during the three visits.\u003c/p\u003e\n\u003cp\u003ePatient satisfaction with using therapeutic VR during the cannulation procedure was also measured in the questionnaire (refer to Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e.), specifically their satisfaction with the immersive environment, breathing exercises and overall feeling of relaxation, from a very dissatisfied to very satisfied scale.\u003c/p\u003e\n\u003cp\u003eWe also used physiological constants such as Heart Rate (measured in beats per minute (BPM)) and Blood Pressure (measured in millimeters of mercury (mmHg)), after the SOC and VR procedure, to provide more objective measures.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eStatistical analysis\u003c/h2\u003e\n\u003cdiv id=\"Sec9\" class=\"Section3\"\u003e\n\u003ch2\u003eSize Calculation\u003c/h2\u003e\n\u003cp\u003eGiven the exploratory nature of the trial, we determined sample size based on the number of potential orders of VR sessions (18 in total). To ensure balanced representation, we planned for at least two participants per order (36 minimum). To account for attrition and missing data, 100 patients were targeted, with 80% power to detect a clinically significant difference of greater than 2, with an alpha threshold of 0.05.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003ePresentation of data and analysis\u003c/h3\u003e\n\u003cp\u003eQuantitative data was presented with either the mean and standard deviation or median and quartiles, depending on the distribution of the data. For qualitative data, we used n for the number of data points and frequency as a percentage. All VR sessions were analyzed on an intent-to-treat basis.\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n\u003ch2\u003ePrimary endpoint\u003c/h2\u003e\n\u003cp\u003eData for heart rate and blood pressure were calculated as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD or median and interquartile range (IQR). These calculations were conducted in line with the Kolmogorov\u0026ndash;Smirnov test. Categorical variables were summarized as frequencies and percentages. The student\u0026rsquo;s paired t-test or the Wilcoxon signed-rank test were used to compare variables between the SOC and VR sessions. To explore independent predictors of outcomes, we performed stepwise linear regression modeling.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n\u003ch2\u003eSecondary endpoints and safety and feasibility\u003c/h2\u003e\n\u003cp\u003eAny form of cybersickness (vertigo, nausea, or vomiting associated with visuospatial changes) was reported by patients if present after every VR session. The ease of use of the devices was also assessed by using a numeric rating scale (NRS) (where 0 was extremely difficult to use and 10 was the easiest possible thing to use). Any incidents occurring during the sessions were also recorded and investigated by the team.\u003c/p\u003e\n\u003cp\u003eStatistical methods were adapted from previously published approaches to VR interventions in clinical trials [\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e].\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eDuring the study period, 180 patients were admitted to the Dubai Thalassemia Center. Of these, 65 patients were excluded due to not meeting inclusion criteria, declining to participate, or screening failure, leaving 115 patients who were enrolled and included in the analysis (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eAll 115 enrolled patients completed at least one standard-of-care (SOC) session, and 111 of these patients also completed at least one virtual reality (VR) intervention session in addition to SOC. Among those 111 patients, 70 completed all three scheduled visits. The remaining 41 patients did not complete their second VR intervention session for reasons such as missed appointments or fear in the case of pediatric patients.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eOverall, 82% of the patients were older than 18 years, and 51% were male. The mean age of the participants was 26 years. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents the demographic and clinical characteristics of the study population.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristics\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAll\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eVR Group\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eSOC Group\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (yr)\u003c/p\u003e\u003cp\u003eGender (F/M)\u003c/p\u003e\u003cp\u003eBMI (kg.m\u0026thinsp;\u0026minus;\u0026thinsp;2)\u003c/p\u003e\u003cp\u003ePulse\u003c/p\u003e\u003cp\u003eArterial pression (Systolic)\u003c/p\u003e\u003cp\u003eArterial pression (Diastolic)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e26 [9\u0026ndash;46]\u003c/p\u003e\u003cp\u003e(51%) / (49%)\u003c/p\u003e\u003cp\u003e22 [13\u0026ndash;45]\u003c/p\u003e\u003cp\u003e95\u003c/p\u003e\u003cp\u003e112 (87\u0026ndash;160)\u003c/p\u003e\u003cp\u003e77 (65\u0026ndash;98)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e87\u003c/p\u003e\u003cp\u003e112 (87\u0026ndash;144)\u003c/p\u003e\u003cp\u003e81 (77\u0026ndash;94)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e97\u003c/p\u003e\u003cp\u003e105 (90\u0026ndash;160)\u003c/p\u003e\u003cp\u003e78 (65\u0026ndash;98)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe mean anxiety score was significantly lower in VR group 2.24 (\u0026plusmn;\u0026thinsp;2.6) than in SOC 2.92 (\u0026plusmn;\u0026thinsp;2.3), (p\u0026thinsp;=\u0026thinsp;0.02). Similar to the anxiety score, the fatigue score was significantly lower in VR group 1.67 (\u0026plusmn;\u0026thinsp;1.3) vs 2.65 (\u0026plusmn;\u0026thinsp;2.2) in SOC group (p\u0026thinsp;=\u0026thinsp;0.01). A similar reduction was observed in boredom score with the VR group 1.72 (\u0026plusmn;\u0026thinsp;1.4) vs 2.67 (\u0026plusmn;\u0026thinsp;2.2) in SOC Group (p\u0026thinsp;=\u0026thinsp;0.035)\u003c/p\u003e\u003cp\u003eHowever, the mean pain score was not significantly different as compared to VR group 2.23 (\u0026plusmn;\u0026thinsp;1.8) and 2.89 (\u0026plusmn;\u0026thinsp;2.1) for SOC Group (p\u0026thinsp;=\u0026thinsp;0.07). Likewise, the heart rate was not significantly different in VR group 62 bpm vs 65 bpm in SOC group.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eSatisfaction and Safety\u003c/h2\u003e\u003cp\u003eOverall patient satisfaction was systematically better in VR group despite not being statistically significant (90% in VR vs. 85% in SOC; p\u0026thinsp;=\u0026thinsp;0.237). Additionally, no VR-related side effects were reported, and tolerability was excellent.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe main findings of this cross-over study are that using virtual reality as adjuvant electronic relaxation devices is feasible, safe, and well tolerated in more than 90% of thalassemia patients undergoing routine intravenous cannulations or TDT procedures.\u003c/p\u003e\u003cp\u003eOur finding indicates that while using VR, anxiety and fatigue were found to be significantly lower compared to SOC sessions. This result is reinforced by a significantly greater decrease in fatigue and boredom scores in the VR group compared to standard of care, which is especially important since the intervention has to repeated for life. Other parameters, such as pain and patient satisfaction, showed no statistically significant differences between VR usage and SOC sessions. This can be explained by the low baseline pain level and patients who are accustomed to the intervention. On the other hand, the overall patient satisfaction score was higher with VR but the difference did not reach statistical significance.\u003c/p\u003e\u003cp\u003ePrevious studies have shown compelling evidence for the efficacy of VR as a distraction tool to reduce pain in invasive procedures both overall and specifically in pediatric patients [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Using audio hypnosis along with VR was also found to be effective in reducing pain unpleasantness by 25% more than just VR [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAnxiety was found to be significantly reduced from 7.2\u0026thinsp;\u0026plusmn;\u0026thinsp;3.3 pre-intervention to 4.6\u0026thinsp;\u0026plusmn;\u0026thinsp;3.0 post-intervention on the Hospital Anxiety and Depression (HAD) Scale while using VR during gynecological surgeries by Chan et al [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. Gold and Mahrer found a reduction in pain and anxiety using VR in blood draws, with a greater reduction in anxiety in those with higher reported anxiety levels [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eBased on prior literature, it can be observed that reported fear surrounding needles is considerably higher in pediatric patients [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e], creating a greater opportunity for reduction in parameters such as anxiety in this population, which only comprised of around 18% of our study sample. With more naive or pediatric patients, greater distress could have been reported in SOC sessions and potentially greater reductions in these measures with therapeutic VR.\u003c/p\u003e\u003cp\u003eA systematic review and meta-analysis conducted by Gao et al included data from 27 studies and found a significant reduction in pain, anxiety, and fear in pediatric patients undergoing puncture related procedures as compared to the SOC and to other distraction methods [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e], highlighting the intervention\u0026rsquo;s proven efficacy. A literature review was also carried out by Addab et al, which illustrated VR\u0026rsquo;s effectiveness in reducing pain and anxiety in use cases such as burn wound care, dental, and needle-related procedures [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eInterestingly, another systematic review and meta-analysis conducted by Czech et al including 7 studies found a significant reduction in pain, but no statistically significant reduction in fear or anxiety, or any improvement in satisfaction overall [\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. These results contrasted our findings of reduced anxiety as opposed to pain but were similar when looking at the satisfaction with the intervention.\u003c/p\u003e\u003cp\u003eThe findings of this study hold significant implications for improving patient care during cannulations and similar invasive procedures, particularly in patients requiring frequent interventions, such as those with hemoglobinopathies.\u003c/p\u003e\u003cp\u003eAnxiety and fear, especially surrounding needles, are significant in pediatric populations [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e] and therapeutic VR provides an option for their management. With the prevalence of haemoglobinopathies in the region [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], invasive procedures involving needles are not uncommon and create a serious burden for the UAE and surrounding nations. VR can be used in addition to traditional management techniques for pain, anxiety, fatigue, and boredom to further enhance patient experience during invasive procedures and alleviate long-term psychological effects of these symptoms on patients\u0026rsquo; lives.\u003c/p\u003e\u003cp\u003eThe primary strength of our study is being, based on our research, the first use of therapeutic VR for a study in the region and being tailored to the UAE population, specifically those with haemoglobinopathies requiring cannulations. Due to the prevalence of haemoglobinopathies in the region [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] and around 399\u0026nbsp;million carriers of thalassemia trait in the world [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e], these findings are particularly impactful for the local population.\u003c/p\u003e\u003cp\u003eThough found to be statistically insignificant upon analysis, another strength of our study was the use of physiological constants to gain an objective angle to our data. Heart rate and blood pressure measurements were collected after the cannulation procedure to determine any stress responses as they were carried out.\u003c/p\u003e\u003cp\u003eA drawback of our study is the limited overall pain, anxiety, fatigue, and boredom experienced by the sample population. With all mean reported values being relatively low on the VAS, discomfort was minimal due to the chronic nature of the participants\u0026rsquo; conditions and repeated cannulations experienced throughout their lives. The procedure being relatively short (3\u0026ndash;5 minutes) reduces the perception of boredom during the procedure, and more tedious or painful procedures could have shown higher scores or greater differences in these parameters.\u003c/p\u003e\u003cp\u003eAdditionally, as opposed to a modified VAS scale, using the Hospital Anxiety and Depression Scale could have been more appropriate to assess anxiety, as was done by Chan et al [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAn even distribution of male and female participants allows application to both populations, but generalizability of this study may be limited to those requiring routine invasive procedures such as individuals with haemoglobinopathies undergoing routine cannulations.\u003c/p\u003e\u003cp\u003eIn order to further validate the use of therapeutic VR for issues such as pain, anxiety, boredom, and fatigue, a similar study could be carried out with other distractive techniques used as a control against VR as was carried out by Erdogan et al [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eExploring other use cases with higher reported discomfort (pain, anxiety, fatigue, or boredom) such as chemotherapy may also be of value to yield greater benefit from the intervention and in turn, more significant results.\u003c/p\u003e\u003cp\u003eFurthermore, data for other parameters such as skin conductance or eye tracking could be gathered in future works for a less subjective approach which relied on self-reported data.\u003c/p\u003e\u003cp\u003eA study with exclusively naive or pediatric patients would likely provide more benefit to patients as they have not had as much time to become accustomed to the cannulation procedure as long-time patients and tend to have greater anxiety and/or pain with regards to the cannulation procedure.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eTherapeutic VR has been shown to be effective as a distraction tool in reducing anxiety and fatigue in cannulations for chronic patients and shows promise for other use cases based on previous literature, especially in pediatric and potentially naive patients. Future research should focus on more distressing use cases and other objective outcome measures to fully elucidate the scope of VR\u0026rsquo;s benefits in healthcare settings.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eBPM\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eBeats Per Minute\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eCONSORT\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eConsolidated Standards of Reporting Trials\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eHAD\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHospital, Anxiety and Depression\u003c/p\u003e\u003c/div\u003e\u003c/div\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\"\u003eMBRU\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eMohammed Bin Rashid University\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSOC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eStandard of Care\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eTDT\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eThalassemia Dependent Transfusions\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eUAE\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eUnited Arab Emirates\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eVAS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eVisual Analogue Scale\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eVR\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eVirtual Reality\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003emmHg\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eMillimeters Per Mercury\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\u003cp\u003e This study was approved by the MBRU Student and Resident Research Ethics Subcommittee and Dubai Scientific Research Ethics Committee (MBRU IRB-2024-80) and was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrolment. For patients aged 18 and below, written informed consent was provided to the parents/legal guardians, in addition to the assent form provided to the patient.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003cp\u003eNot applicable.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003ch2\u003eCompeting interests\u003c/h2\u003e\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e\u003cp\u003eThis work was supported by Dubai Health. The funders had no role in study design, data collection, analysis, interpretation of data, or in writing the manuscript.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eYH conceived and designed the study. SAK, FSM, and HIR contributed to study design, data collection, analysis, and drafting of the manuscript. FA, AS, and BA facilitated patient recruitment and site coordination. All authors reviewed, revised, and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eWe would like to sincerely thank the nursing team at the Dubai Thalassemia Center for their invaluable support, and the Research Methods faculty at MBRU for their guidance throughout this project.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets generated during the study are not publicly available due to ethical restrictions, but are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eIMHE. 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J Clin Med 10:3248. 10.3390/ jcm10153248\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"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":"Virtual reality, Pain, Anxiety, Medical hypnosis, Intravenous cannulation, Thalassemia, UAE, Crossover clinical trial","lastPublishedDoi":"10.21203/rs.3.rs-7539274/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7539274/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003ePatients with β-Thalassemia frequently experience repeated hospital visits and cannulations, leading to chronic pain and anxiety, which adversely affect their quality of life. Virtual Reality (VR) has been shown the efficacity to manage the pain and anxiety associated with medical procedures. The purpose of this study was to evaluate the effects of therapeutic VR on pain, anxiety, fatigue, satisfaction, and boredom during intravenous (IV) cannulations in comparison to standard of care (SOC).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eA total of 115 patients completed the SOC session and 111 patients completed the VR session. Overall, 82% of the patients were older than 18 years, and 51% were male. The mean anxiety score was significantly lower in VR group 2.24 (±2.6) than in SOC 2.92 (±2.3), (p=0.02). Similar to the anxiety score, the fatigue score was significantly lower in VR group 1.67 (±1.3) vs 2.65 (±2.2) in SOC group (p=0.01). No side effects were reported in relation to the VR intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eThe usage of VR for the intervention is feasible, safe, and well-tolerated by over 90% of thalassemia patients. VR effectively reduces anxiety and fatigue during cannulations for thalassemia patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical Trial Registration:\u003c/strong\u003e https://clinicaltrials.gov/study/NCT07099196, identifier: NCT07099196, registered 2025-07-05. This trial was registered retrospectively.\u003c/p\u003e","manuscriptTitle":"Impact of Virtual Reality on Pain and Anxiety During Intravenous Cannulation Procedures Among Thalassemia Patients in the UAE: A Crossover Clinical Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-23 08:29:28","doi":"10.21203/rs.3.rs-7539274/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":"0d651bf7-7c62-4552-aa31-a29d8587155e","owner":[],"postedDate":"September 23rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-02-19T17:25:33+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-23 08:29:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7539274","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7539274","identity":"rs-7539274","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}