Implementing Video-Based 5Ts Teach-back Health Education in pediatric circumcision to improve surgical experience in children and their parents: Study protocol for a randomized controlled trial

Implementing Video-Based 5Ts Teach-back Health Education in pediatric circumcision to improve surgical experience in children and their parents: Study protocol for a randomized controlled 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 Study protocol Implementing Video-Based 5Ts Teach-back Health Education in pediatric circumcision to improve surgical experience in children and their parents: Study protocol for a randomized controlled trial Jia Li, Jiangtao OuYang, Bin Wang, Jing Chen, Jiali Wu, Xujuan Zheng This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6156186/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 Pediatric circumcision is widely performed. However, both children and their parents still face issues of surgical anxiety and negative surgical experience, which adversely affect family life. Health education has shown potential in improving these situations. However, existing health education programs primarily focus on children rather than both children and their parents, and these programs lack theoretical support. This study aims to develop an innovative health education strategies to address these issues effectively. Aim To evaluate the effects of video-based 5Ts Teach-back health education for circumcised children and their parents in terms of reducing anxiety, postoperative complications, and unnecessary postoperative visits; and improving satisfaction with overall health education. Methods This study will use a single-blind, parallel-group randomized controlled trial (RCT) design. 144 participants will be enrolled, with one parent-child pair considered as one dyad. Based on King’s Theory of Goal Attainment and the Feedback Theory, the video-based 5Ts teach-back method consists of four steps: (a) Perception, (b) Judgment, (c) Action, and (d) Evaluation. Circumcised children and their parents will be recruited from the urology clinic or ward of a university-affiliated hospital in China. The participants will be randomly assigned to the intervention group (N = 72), which will receive the video-based 5Ts teach-back method before and one week after surgery, and the control group (N = 72) which will receive routine health education. Anxiety, postoperative complications, unnecessary postoperative visits, and satisfaction with health education will be measured at baseline, 1 week after surgery (Test 1), and 2 weeks after surgery (Test 2). Discussion If effective, the intervention will offer a convenient and impactful health education program for circumcised children and their parents; and could become the routine health education for healthcare professionals to improve the child's postoperative recovery and the family's mental well-being. As the first RCT to test the effects of the video-based 5Ts Teach-back method for families of circumcised children in China, the results will provide evidence-based insights for health education on pediatric circumcision and reduce the educational burden on clinical nurses. Trial registration: ChiCTR2400093255. Date of registration: 29 November 2024 Circumcision health education Teach-back anxiety Figures Figure 1 Figure 2 1. Background Male circumcision, a common surgical procedure in pediatric patients, has been shown to offer significant health benefits [1, 2] . It effectively reduces the incidence of urinary tract infections in children [3] . Additionally, it lowers the risk of HIV transmission by 50%-60%, and reduces the risk of male acquisition of herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV) by 30% [4] . Voluntary medical male circumcision may save approximately $ 165 billion by 2025 from averted HIV treatment and associated costs [5] . With growing awareness of the health benefits of circumcision, an increasing number of parents are opting to have their minor children undergo the procedure [6] . Despite the advantages of circumcision, pediatric surgeries, even minor ones, are still stress remains a significant concern for families, often causing considerable stress and anxiety for both the children undergoing the procedure and their parents [7, 8] . Consequently, many children and their parents report negative experiences associated with the procedure [8, 9] . Anxiety related to pediatric circumcision is prevalent in both children and their parents [10–12] . A significant cause of this anxiety is the insufficient health education provided to both parties, which results in their inadequate understanding of the procedure [13] . Studies have shown that up to 84% of children undergoing circumcision experience fear or anxiety, which can be exacerbated by the uncertainty surrounding the surgery and the postoperative care [14] . This anxiety can lead to several negative outcomes, including increased pain, delayed recovery, and a higher incidence of postoperative complications. Moreover, anxiety in children can result in sleep disturbances and behavioral problems, further affecting their overall recovery and well-being [15] . It may also lead to prolonged sedation and the need for additional care [16, 17] . Parents, who often take on the caregiver role during the perioperative period of their children, also experience significant anxiety [18–20] . Factors contributing to parental anxiety include concerns about their child’s postoperative pain, potential complications, and the uncertainty surrounding the child’s recovery [21] . The lack of sufficient preoperative knowledge, combined with the stress of managing postoperative care, further exacerbates parental anxiety [22–24] . Furthermore, this inadequate knowledge may hinder parents' ability to effectively manage postoperative care, potentially leading to unnecessary emergency room visits and common postoperative complications such as bleeding, swelling, and adhesions [24–26] . Given these challenges, it is crucial to find effective methods to address the psychological impact of circumcision on both parents and children. Health education interventions have shown promise in reducing preoperative anxiety and promoting a better understanding of the procedure, thus enhancing the overall surgical experience for both parents and children [27, 28] . However, traditional health education approaches, such as verbal explanations and printed materials, often fail to address the emotional and informational needs of families effectively [29, 30] . These methods can also be overly monotonous, lack clarity, and may result in misunderstandings or information overload [31–34] . Two promising educational approaches are video-based education and the teach-back method. Video education, which is intuitive, concise, and informative, has been shown to improve self-care and reduce anxiety in both children and parents [35–38] . The teach-back method, which involves reinforcing key information through patient interaction, has also been found to improve educational outcomes [39, 40] . Studies combining these two methods, especially in the context of circumcision, have demonstrated their ability to alleviate anxiety of patients and improve postoperative recovery [41] . For instance, Wang et al. (2023) combined video and teach-back strategies to deliver health education to circumcision patients aged 11–38 in China, which reduced the incidence of complications and increased patient satisfaction [41] . Therefore, implementing a video-based teach-back health education program in circumcision appears both feasible and potentially effective. However, such a combination strategy has not been provided to the parents of circumcised children, and it currently lacks theoretical foundation and a standardized definition. Therefore, it is necessary to develop a theoretically based, innovative, and easily accessible intervention for children undergoing circumcision and their parents. The protocol of this study was designed an innovative health education intervention strategy—Video-based 5Ts Teach-back Health Education (V5TTHE)—to enhance the surgical experience for both children undergoing circumcision and their parents. The core of this strategy combines video education with the teach-back method, supported by theoretical frameworks. V5TTHE seeks to provide essential knowledge about circumcision to both children and their parents, while also equipping parents with the necessary tools to effectively manage postoperative care. The primary objectives of this intervention are to alleviate anxiety in both children and parents, reduce the incidence of postoperative complications, decrease the rate of unnecessary medical consultations, and increase satisfaction with health education. 2. Methods 2.1 Aim and Hypotheses This study aims to evaluate the effects of video-based 5Ts teach-back health education on the surgical experiences of circumcised children and their parents, including anxiety levels, postoperative complications, unnecessary medical consultations, and satisfaction with health education. We hypothesize that participants in the intervention group will be reported to have the significant differences compared to the control group: (1) Reduced anxiety in both children and parents; (2) Fewer postoperative complications in children; (3) Lower rate of unnecessary medical consultations; (4) Greater satisfaction with health education regarding circumcision. 2.2 Design A single-blind, parallel-group, randomized controlled trial (RCT) was designed for the study. The research follows the SPIRIT 2013 Statement and the guidelines for the Standard Protocol of Clinical Trials [42] . The Consolidated Standards of Reporting Trial (CONSORT) flowchart is presented in Fig. 1 [43] . 2.3 Study Setting The study will be conducted at a university-affiliated tertiary public hospital in China, with a pediatric urology subspecialty in the Department of Urology. 2.4 Participants Participants who meet the inclusion criteria will be recruited. The inclusion criteria are: (1) Children undergoing their first male circumcision, along with their parents; (2) Children aged 6–15 years [44] ; (3) Children and parents who can complete the task of watching the video. The exclusion criteria are: (1) A history of depression; (2) Children or parents with serious physical or mental illness, such as cancer, severe depression, or congenital heart disease; (3) Undergoing psychotherapy or any other physical or psychological intervention. The sample will be estimated based on previous studies with a medium effect size [33] . With a power of 0.80, an alpha set at 0.05, and an effect size of 0.5 for the primary outcome of The Screen for Child Anxiety Related Emotional Disorders (SCARED) [45] , each group will be 64 participants. We estimate a 10% attrition rate, requiring a minimum of 144 participants (72 per group). Each parent-child dyad will be treated as a single unit of recruitment. 2.5 Recruitment Participants will be recruited when children are admitted to the urology outpatient clinics or wards in hospitals. Nurses will introduce the trial to children and parents who meet the inclusion criteria. The children and their parents who verbally agree to participate will be approached by the researchers to provide them with an information sheet and to answer any questions about the research. If both the child and the parents are willing to participate, they will be asked to sign an informed consent form and be informed of freedom to withdraw whenever they want. Data will be collected before randomization (baseline), one week after surgery (test 1), and two weeks after surgery (test 2). Recruitment of participants began in January 2025. Primary endpoints (baseline and test 1) and follow-up measures (test 2) will be expected to be completed by October 2025. 2.6 Randomization and Blinding Participants will be randomly assigned to the intervention or control group with a 1:1 allocation ratio. Sequence randomization will be performed using a computerized random number generator, with the results stored in a sealed and opaque envelope. Blinding will not be possible for the researchers during the study; however, group allocation will remain masked until baseline data are complete. Outcome assessors and data analysts will be blinded to group allocation throughout the study. 2.7 Intervention 2.7.1 control group The children and parents in the control group will receive routine health education, which includes three sessions of pediatric circumcision health education: before surgery, immediately after surgery, and before discharge. The third health education session for families of outpatient surgery patients will be rescheduled from pre-discharge education to the one-week postoperative follow-up visit. The educational content includes. (1) preoperative education on psychological care and preparation; (2) postoperative education on wound care, pain management, dietary care, and daily living; and (3) discharge guidance on wound care, dietary recommendations, activity guidelines, complications awareness, and review reminders. During these sessions, the nurses will address any questions from participants regarding circumcision. If no questions are raised, the session will be concluded. Researchers and urology specialist nurses at the hospital will be responsible for delivering the intervention. The children and their parents will receive two follow-up visits. Face-to-face visits will be the preferred method. However, families who are unable to return to the hospital will be followed up through WeChat or phone. The follow-up visits will be conducted at the time of the one-week postoperative review. Table 1 describes the interventions in detail. Table 1 The details of the intervention Control Group Intervention Group Service Routine health education V5TTHE + Routine health education Place Hospital, home Hospital, home Form Face-to-face oral communication Phone communication Face-to-face and Video Phone and WeChat Provider Researchers and urology specialist nurses Researchers Contents Routine health education visiting Perception, judgment, action, and evaluation visiting Duration Preoperative, postoperative and pre-discharge Each health education takes 15–20 minutes Preoperative, postoperative and pre-discharge Each health education takes 15–20 minutes Assessment Baseline (pre-intervention) test 1 ( 1 week after operation ) test 2 ( 2 weeks after operation ) Baseline (pre-intervention) test 1 ( 1 week after operation ) test 2 ( 2 weeks after operation ) 2.7.2 Intervention group The children and parents in the intervention group will receive video-based 5Ts teach-back health education (V5TTHE) in addition to routine health education. The V5TTHE method was developed using the theoretical framework incorporated King's Theory of Goal Attainment and Feedback Theory [46, 47] . Sound evidence identified that child and parent anxiety and the child's postoperative complications are essential components to affect their disease experience [48] . V5TTHE is designed to reduce anxiety in both children and parents, decrease the incidence of postoperative complications to lower the rate of unnecessary medical consultations and increase satisfaction, then help families navigate the perioperative period and smooth recovery. The core of King's Theory of Goal Attainment is the achievement of goals through the interaction, transaction, and communication between nurses and patients [46] . In practice, both parties attain interaction, transaction, and goal attainment through the cyclical process of "perception—judgment—action—reaction [49] ." King's Theory of Goal Attainment has been shown to enhance the patient's comprehension and retention of health-related knowledge, thereby improving recovery outcomes and increasing patient satisfaction [50–52] . The feedback theory refers to the process by which a system returns output information as part of the input information to adjust and control the system [47] . The theory aligns with the concept of King’s Theory of Goal Attainment, which similarly improves the outcomes of health education [53, 54] . In this study, V5TTHE follows the three steps of perception, judgment, and action from the Theory of Goal Attainment, with the reaction step represented through the cycle of evaluation and reconstruction. The feedback theory runs through the action phase, manifested as the participants' teach-back and the researchers' subsequent teaching. The entire process of V5TTHE aligns with the core principles of both theories, promoting learning outcomes through continuous interaction and cycles (Fig. 2 ). The perception stage is the initial phase of the intervention. It begins with formal introductions and in-depth communication between the researchers, children, and parents. This phase aims to establish trust and rapport, which are crucial for the success of the intervention. The researchers will employ a range of methods to assess the children's and parents' understanding, including direct communication, situational assessments, questionnaires, and standardized scale evaluations. The judgment stage involves researchers and parents collaboratively setting goals based on the assessment results and identifying key learning objectives. In the judgment stage, researchers and parents need to collaboratively set learning goals based on the assessment results. Researchers will determine the learning priorities for each individual during the subsequent feedback stage, based on their specific circumstances. In the action phase, parents in the intervention group will be asked to watch the health education video. Following the viewing, they will begin the feedback process. This process requires parents to articulate the knowledge they have learned by answering the researchers' questions in their own words. If parents provide incorrect or incomplete responses, they will receive further detailed explanations from the researcher. The session will be considered complete when the parents have demonstrated full comprehension of the educational content. Each intervention session will last 15–20 minutes. The "5T" principle will be followed throughout the action phase. It is derived from the "5Ts Teach-back" method, a health communication strategy developed by Catherine M.’s team [55] . It includes five steps: Triage, Tool, Take Responsibility, Tell me, and Try again. (1)Triage: In this step, researchers will identify the key educational priorities for each participant based on individual needs. This step is crucial in preventing information overload for the learner. (2)Tools: The primary tool used in this study will be video. Both children and parents can reinforce the knowledge at any time and in any location, enabling flexible and continuous learning. The V5TTHE videos will feature visual elements of the hospital environment and medical equipment to explain the health knowledge related to pediatric circumcision. These elements are designed to alleviate discomfort stemming from the unfamiliar hospital setting, while simultaneously enhancing children's trust and reducing their anxiety about the procedure. Key nursing procedures, such as wound care and postoperative guidance, will be demonstrated in these videos using models. This approach allows parents to visually observe the procedures involved in their child's recovery, making it easier for them to learn and apply the necessary care techniques. In addition, the videos are designed with storylines featuring questions commonly asked by parents. Solving the problems, through embedded storytelling, will encourage active learning and ensure that the viewers feel their specific needs are being addressed. Finally, to further engage viewers and improve comprehension, the videos will be supplemented with explanatory text, animations, and background music. To ensure the audience can easily grasp complex concepts, simple language will be provided as a substitute for technical medical terms. (3)Take Responsibility: This step occurs after the learner receives the information. The ideal Take Responsibility line contains two elements. The first is an acknowledgment of the quantity or complexity of the information given. This normalizes misunderstandings if they do occur, thereby reducing shame for the learner. For example, the researcher can say, "The amount of information shared today is quite large; it's normal if it’s hard to remember everything." Secondly, the step emphasizes that parents and children are participants in the learning process rather than patients, which helps reduce their stress. (4)Tell Me: In this phase, researchers will ask parents to express what they have learned in their own words. For example, after showing a video on postoperative care, the researcher may ask, "What do you understand about wound care after circumcision?" In such situations, the large amount of information may leave parents uncertain about where to begin their response. However, a more specific Tell Me line, such as, “What would you do if your child experiences wound bleeding?” This method enables both educators and learners to focus on specific information points, thereby allowing a more accurate assessment of the learner's comprehension of the material. (5)Try Again: If the parents do not understand, they will receive further clarification, possibly through a different explanation. Depending on the extent of misunderstanding, another round of teaching may be necessary. In the meantime, the researcher can also return to the "Take Responsibility" step, apologizing for any unclear explanations, thereby reducing feelings of shame or discomfort parents may have regarding their misunderstanding. Finally, the evaluation stage will take place. During this phase, the researchers will assess whether the learning objectives have been achieved by both the child and the parents. If the objectives are met, the intervention will conclude. If the objectives are not met, the reasons for the shortcomings will be analyzed, and the intervention plan will be adjusted accordingly until the learning goals are successfully achieved. 2.8 Measures 2.8.1 Primary Outcome (1) Anxiety in children and parents Anxiety in children undergoing circumcision will be assessed using the Chinese version of The Screen for Child Anxiety Related Emotional Disorders (SCARED) [45] . The 41-item tool utilizes a 3-point Likert score from 0 (never) to 2 (often). A total score of ≥ 23 indicates a likelihood of anxiety, with higher scores indicating more severe anxiety symptoms. The internal consistency of the Chinese version of SCARED has been reported as 0.89, with a test-retest reliability coefficient of 0.77 [56] . Additionally, the scale demonstrates good discriminant validity, distinguishing between anxiety and non-anxiety disorders [56] . The Chinese version of the State-Trait Anxiety Inventory (STAI) will be used to measure anxiety in the parents of the children [57] . The STAI consists of 40 items divided into two sections: state anxiety (a transient emotional state) and trait anxiety (a relatively stable anxious personality trait). Each item is rated on a 1–4 scale, with higher scores indicating higher levels of anxiety. The STAI (two parts) has demonstrated good reliability and validity. The Cronbach’s alpha coefficients for the two parts were 0.87 and 0.84, the test-retest reliabilities were 0.73 and 0.81, and the Pearson correlation coefficient for the Chinese version was 0.97 [58] . (2) Incidence of post-circumcision complications (IPCC) The IPCC is defined as the percentage of patients who experience complications following circumcision. The criteria for assessing complications are based on physicians' clinical experience as well as the "Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases" [59] and the "Expert Consensus on Phimosis, Redundant Prepuce, and Prepuce-Related Diseases" [1] . 2.8.2 Secondary Outcome (1) Proportion of unnecessary postoperative visits (PUPV) This outcome includes both online and offline visits. Unnecessary postoperative visits are defined as non-urgent or unnecessary medical and nursing care sought by patients [60–62] . The PUPV will be calculated as the ratio of unnecessary visits to the total number of visits over a specified period. A multidisciplinary team, including doctors, nurses, and other healthcare professionals, will assess whether a visit is unnecessary. The assessment will consider factors such as the timing and reason for the visit, symptoms, and diagnosis, which will be derived from the hospital's electronic medical records system and patient follow-up data. (2) satisfaction with health education: Parents' satisfaction with health education will be assessed with a 3-item questionnaire developed by the researchers. The items are “Overall, how satisfied with the health education you received?”, “Please give your reasons”, and "Please give your advice". A 5-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = moderately satisfied, 4 = satisfied, 5 = very satisfied) will be used to assess the overall satisfaction. 2.9 Data Collection Baseline assessments will be conducted by the study team. Participants will be asked to complete the SCARED, the STAI, and a social-demographic and clinical data questionnaire during their visit to the urology outpatient clinic or ward. Follow-up assessments will take place at two time points: one week and two weeks post-surgery. At these two follow-up assessments (Test 1 and Test 2), the researcher will administer the SCARED and the STAI to participants in a face-to-face setting, instructing them to complete the scales. Additionally, at Test 2, participants will be asked to fill out a health education satisfaction questionnaire and report any complications or unnecessary postoperative visits. In cases where participants are unable to return to the hospital for in-person assessments, an electronic version of the questionnaire will be sent via WeChat or email, with the completed form returned in the same manner. To enhance adherence to the study protocol, ensure participant retention, and support complete follow-up, participants will receive online reminders before each scheduled assessment. Table 2 shows the study variables and assessment time points. Table 2 The study variables and assessment time points Variables Time point Baseline (T0) 1 week after operation (T1) 2 week after operation (T2) Social-demographic and clinical data * Primary Outcome The anxiety of children and parents * * * Incidence of complications after circumcision * * Secondary Outcome Unnecessary visits * Patient or parent satisfaction with health education * 2.10 Data Analysis Data will be analyzed using the Statistical Package for Social Sciences (SPSS 29.0). An intent-to-treat (ITT) analysis will be employed to handle missing data. Descriptive statistics will be used to summarize the social-demographic and clinical characteristics, including means, standard deviations (SDs), frequencies, and percentages. The Chi-square (Χ²) test for categorical variables and independent sample t-tests for continuous variables will be used to identify significant differences in social-demographic and clinical characteristics, as well as baseline outcomes, between the control and intervention groups. The effect of the intervention on reduced anxiety in circumcised children and their parents across the three points will be evaluated via repeated measures multivariate analysis of covariance to explore how outcomes have changed between groups, over time, and the interaction between groups and time. The incidence of circumcision complications and unnecessary postoperative visits between the two groups will be compared using chi-square tests. The independent t-test will be used to compare satisfaction with health education between the intervention group and the control group. 3. Validity and Reliability The study adopts a rigorous research design, grounded in a solid theoretical framework, and utilizes tools with established reliability and validity. The RCT is supported by an adequate and representative sample, ensuring the robustness and generalizability of the findings. Recruitment and randomization procedures will adhere to strict protocols to minimize selection bias while ensuring complete random allocation. To reduce the potential for bias, all researchers involved in the intervention delivery will undergo standardized training, which will help mitigate the Hawthorne effect. Additionally, outcome assessors and data analysts will remain blinded to group allocation throughout the study to further reduce biases in evaluating the effects of the intervention. 4. Discussion To our knowledge, this study will be the first RCT to employ the video-based 5Ts Teach-back method for health education targeting both children undergoing circumcision and their parents. On one hand, V5TTHE may alleviate both the physical and psychological burdens experienced by children and their parents, potentially reducing the need for unplanned medical care. On the other hand, the flexibility and time efficiency of video education could make it an attractive alternative for families facing location or time constraints in attending traditional in-person health education sessions. If this study proves effective, it will provide valuable insights into the role of health education in enhancing children's and parents' understanding of pediatric circumcision, and contribute to alleviating their anxiety and improving postoperative care for the children. Even if the results are null, parents will gain a deeper understanding of circumcision-related health education, which may help reduce healthcare disparities and promote equity in education. However, some limitations need to be noted in the research. First, due to the study design, blinding of researchers during all phases of the study will not be feasible, which may introduce potential bias. Second, the reliance on parents to report anxiety levels for their children may introduce reporting bias, especially if children are unable to independently complete the anxiety scale for various reasons. Finally, due to time and financial constraints, we will be unable to conduct extended follow-up assessments, which limits our ability to determine the long-term persistence of surgical anxiety and its potential impact on the children’s post-operative life. 5. Conclusions The research will contribute to evidence on the effectiveness of implementing health education to support circumcised children and their parents. By combining video-based education with the Teach-back method, this innovative intervention holds promise for improving both the physical and psychological well-being of the children and parents, reducing the need for unplanned medical visits, and increasing satisfaction with health education. If successful, the V5TTHE intervention could be integrated into clinical practice, offering significant benefits for both patients and healthcare providers by improving the overall disease experience and alleviating the burden of health education on clinical staff. Moreover, this intervention could serve as a model for future research and interventions, such as designing culturally appropriate health education programs for families of children undergoing circumcision in different countries. Abbreviations RCT Randomized controlled trial HSV-2 Herpes simplex virus type 2 HPV Human papilloma virus V5TTHE Video-based 5Ts Teach-back Health Education CONSORT Consolidated Standards of Reporting Trial SCARED Screen for Child Anxiety Related Emotional Disorders STAI State-Trait Anxiety Inventory IPCC Incidence of post-circumcision complications PUPV Proportion of unnecessary postoperative visits ITT Intent-to-treat SDs Standard deviations Declarations Authors' contributions Conceptualization: JL, JTOY; Design of the study: JL, BW; Draft of the manuscript: JL, XJ Z; Preparation of the study: JL, JTOY, JC, JLW; substantial revisions of the manuscript: JL, JTOY, BW, XJZ, JC, JLW. All authors read and approved the final manuscript. Funding Xujuan Zheng (X.Z.) was supported by the General Program of Stable Support Plan for Universities in Shenzhen City (grant no. 20200804101756002). Acknowledgements Not applicable. Availability of data and materials Not applicable. Ethics approval and consent to participate The study has been approved by the Science and Technology Ethics Committee of Shenzhen University General Hospital (Approval No. KYLL-20241104A). Its registration number with the Chinese Clinical Trial Registry is ChiCTR2400093255. This research will adhere to the ethical standards of the Declaration of Helsinki throughout the study. Informed consent will be obtained from all participants or their guardians prior to baseline data collection. There are no potential risks or harms to participating in this study. Children will not be deprived of any routine care and treatment. All participant information will remain confidential. Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. References Chinese Expert Consensus on Phimosis, Excessive Prepuce, and Prepuce-Related Diseases [J]. National Journal of Andrology, 2021, 27(09): 845 − 52. 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SJöBERG C, SVEDBERG P, NYGREN J M, et al. Participation in paediatric perioperative care: 'what it means for parents' [J]. J Clin Nurs, 2017, 26(23–24): 4246-54. MARQUES A, SANTOS E, NIKIPHOROU E, et al. Effectiveness of self-management interventions in inflammatory arthritis: a systematic review informing the 2021 EULAR recommendations for the implementation of self-management strategies in patients with inflammatory arthritis [J]. RMD Open, 2021, 7(2). LEWINSKI A A, ANDERSON R A, VORDERSTRASSE A A, et al. Analyzing Unstructured Communication in a Computer-Mediated Environment for Adults With Type 2 Diabetes: A Research Protocol [J]. JMIR Res Protoc, 2017, 6(4): e65. BRADY M T. Newborn Male Circumcision with Parental Consent, as Stated in the AAP Circumcision Policy Statement, Is Both Legal and Ethical [J]. J Law Med Ethics, 2016, 44(2): 256 − 62. SüTŐ J, KLEKNER Á, NAGY J, et al. [The effect of surgical psychoeducation on the outcome of spinal surgery] [J]. 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Using videotape modeling to prepare children psychologically for surgery: influence of parents and costs versus benefits of providing preparation services [J]. Health Psychol, 1989, 8(1): 79–95. GLASCOE F P, TRIMM F. Brief approaches to developmental-behavioral promotion in primary care: updates on methods and technology [J]. Pediatrics, 2014, 133(5): 884 − 97. YEN P H, LEASURE A R. Use and Effectiveness of the Teach-Back Method in Patient Education and Health Outcomes [J]. Fed Pract, 2019, 36(6): 284-9. WANG H, LU R, HUANG L, et al. The Effectiveness of Video-Based Health Education Combined with the Teach-Back Method in Outpatient Circumcision Health Education [J]. Minimally Invasive Medicine, 2023, 18(04): 535-8. CHAN A W, TETZLAFF J M, GøTZSCHE P C, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials [J]. Bmj, 2013, 346: e7586. SCHULZ K F, ALTMAN D G, MOHER D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials [J]. Bmj, 2010, 340: c332. GIARDINO A P, HUDAK M L, SOOD B G, et al. Considerations in the Determination of Medical Necessity in Children: Application to Contractual Language [J]. Pediatrics, 2022, 150(3). BIRMAHER B, KHETARPAL S, BRENT D, et al. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics [J]. J Am Acad Child Adolesc Psychiatry, 1997, 36(4): 545 − 53. KING I M. King's theory of goal attainment [J]. Nurs Sci Q, 1992, 5(1): 19–26. RAMANI S, KöNINGS K D, GINSBURG S, et al. Feedback Redefined: Principles and Practice [J]. J Gen Intern Med, 2019, 34(5): 744-9. GOLOGRAM M, MARGOLIN R, LOMIGUEN C M. Need for Increased Awareness of International Male Circumcision Variations and Associated Complications: A Contemporary Review [J]. Cureus, 2022, 14(4): e24507. WOODS E C. King's theory in practice with elders [J]. Nurs Sci Q, 1994, 7(2): 65 − 9. YANG H, LUO W, DU X, et al. The implementation and effect evaluation of AIDET standard communication health education mode under the King theory of goal attainment: A randomized control study [J]. Medicine (Baltimore), 2023, 102(48): e36083. PARK B M. Development and Effect of a Fall Prevention Program Based on King's Theory of Goal Attainment in Long-Term Care Hospitals: An Experimental Study [J]. Healthcare (Basel), 2021, 9(6). NOROOZI F, DEHGHAN A, BIJANI M, et al. Effects of nurse-led intervention programs based on King's theory of goal attainment on health-promoting behaviors and life satisfaction in patients with type 2 diabetes: a randomized controlled clinical trial [J]. BMC Nurs, 2024, 23(1): 684. BADACZEWSKI A, BAUMAN L J, BLANK A E, et al. Relationship between Teach-back and patient-centered communication in primary care pediatric encounters [J]. Patient Educ Couns, 2017, 100(7): 1345-52. TRAN S, BENNETT G, RICHMOND J, et al. 'Teach-back' is a simple communication tool that improves disease knowledge in people with chronic hepatitis B - a pilot randomized controlled study [J]. BMC Public Health, 2019, 19(1): 1355. ANDERSON K M, LEISTER S, DE REGO R. The 5Ts for Teach Back: An Operational Definition for Teach-Back Training [J]. Health Lit Res Pract, 2020, 4(2): e94-e103. SU L, WANG K, FAN F, et al. Reliability and validity of the screen for child anxiety related emotional disorders (SCARED) in Chinese children [J]. Journal of Anxiety Disorders, 2008, 22(4): 612 − 21. MARTEAU T M, BEKKER H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI) [J]. Br J Clin Psychol, 1992, 31(3): 301-6. DU Q, LIU H, YANG C, et al. The Development of a Short Chinese Version of the State-Trait Anxiety Inventory [J]. Front Psychiatry, 2022, 13: 854547. Guidelines for the Diagnosis and Treatment of Urological Diseases in China (2011 Edition) was published [J]. Journal of Urology for Clinicians(ElectronicVersion), 2011, (3): 54. MORRIS T, MASON S M, MOULTON C, et al. Calculating the proportion of avoidable attendances at UK emergency departments: analysis of the Royal College of Emergency Medicine's Sentinel Site Survey data [J]. Emerg Med J, 2018, 35(2): 114-9. MCABEE K E, PEARLMAN A M, DEEBEL N A, et al. Unplanned In-Global Clinic Visits, Emergency Department Encounters and Hospital Readmissions following Urological Prosthetic Surgery: Data for Quality Improvement [J]. Urol Pract, 2020, 7(2): 132-7. NAOURI D, RANCHON G, VUAGNAT A, et al. Factors associated with inappropriate use of emergency departments: findings from a cross-sectional national study in France [J]. BMJ Qual Saf, 2020, 29(6): 449 − 64. Additional Declarations No competing interests reported. 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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-6156186","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":424843199,"identity":"ca9ac34c-e1f7-4489-abcc-030c76a8b688","order_by":0,"name":"Jia Li","email":"","orcid":"","institution":"Zhuhai Campus of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Jia","middleName":"","lastName":"Li","suffix":""},{"id":424843200,"identity":"77ac47c6-93d5-4daf-acfa-3a1d02ec80f6","order_by":1,"name":"Jiangtao OuYang","email":"","orcid":"","institution":"Zhuhai Campus of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Jiangtao","middleName":"","lastName":"OuYang","suffix":""},{"id":424843201,"identity":"1e5402da-1820-4c6a-b40e-1157e22966e0","order_by":2,"name":"Bin Wang","email":"","orcid":"","institution":"Shenzhen University General Hospital","correspondingAuthor":false,"prefix":"","firstName":"Bin","middleName":"","lastName":"Wang","suffix":""},{"id":424843202,"identity":"d344bd67-a19e-47f5-bbde-0d28f11c2c9d","order_by":3,"name":"Jing Chen","email":"","orcid":"","institution":"Zhuhai Campus of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Jing","middleName":"","lastName":"Chen","suffix":""},{"id":424843203,"identity":"93c2d7cd-e2a5-4a56-994f-6cb1f1576526","order_by":4,"name":"Jiali Wu","email":"","orcid":"","institution":"Zhuhai Campus of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Jiali","middleName":"","lastName":"Wu","suffix":""},{"id":424843204,"identity":"412be40f-e972-4cdc-8d10-ce71ba42c390","order_by":5,"name":"Xujuan Zheng","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+ElEQVRIiWNgGAWjYDACCQjFDMSMDyDsBOK1MBuQpAUE2CSI0iI/u/nYw69th9kNjp89Vvnjz2EGfvYcA4afO3BrYZxzLN1Y5sxhZoMzeWm3eXgOM0j2vDFg7D2DWwuzRI6ZtEQFUMuBHLPbDBKHGQxu5BgwM7bh1sImkf9NWsIAqOX8G7PCHwaHGewJaeGRyGGT/ACy5UaOGQNPAtAWCQJaJCTSzKQZzqQzS954YyzNcyCdR+LMs4KDvXi0yM9Ifib5s806me98juHHH3+s5fjbkzc++IlHCzgIeBgYkuEuBREH8GsABvQPBgY7QopGwSgYBaNgBAMAkMRLYijw1MAAAAAASUVORK5CYII=","orcid":"","institution":"Shenzhen University","correspondingAuthor":true,"prefix":"","firstName":"Xujuan","middleName":"","lastName":"Zheng","suffix":""}],"badges":[],"createdAt":"2025-03-04 17:08:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6156186/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6156186/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":78228442,"identity":"a0d7393c-7079-4d63-bac5-cc6fd77ea619","added_by":"auto","created_at":"2025-03-11 07:13:46","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":411163,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT flowchart of the study.\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-6156186/v1/a69b78e80d3ea37427b37ff3.jpeg"},{"id":78228444,"identity":"21e55488-9cf6-4531-97f3-1d22c6436d97","added_by":"auto","created_at":"2025-03-11 07:13:46","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":370910,"visible":true,"origin":"","legend":"\u003cp\u003e5Ts Teach-Back Method combining attainment theory and teach-back theory.\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-6156186/v1/d0a742b98fd66a6bb592badd.jpeg"},{"id":95718847,"identity":"49eed023-4fa6-41ed-8e52-2909c3488249","added_by":"auto","created_at":"2025-11-12 09:10:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1542872,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6156186/v1/8a6deef0-b98d-4244-bd70-49e1db7d0d70.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Implementing Video-Based 5Ts Teach-back Health Education in pediatric circumcision to improve surgical experience in children and their parents: Study protocol for a randomized controlled trial","fulltext":[{"header":"1. Background","content":"\u003cp\u003eMale circumcision, a common surgical procedure in pediatric patients, has been shown to offer significant health benefits \u003csup\u003e[1, 2]\u003c/sup\u003e. It effectively reduces the incidence of urinary tract infections in children \u003csup\u003e[3]\u003c/sup\u003e. Additionally, it lowers the risk of HIV transmission by 50%-60%, and reduces the risk of male acquisition of herpes simplex virus type 2 (HSV-2) and human papillomavirus (HPV) by 30% \u003csup\u003e[4]\u003c/sup\u003e. Voluntary medical male circumcision may save approximately \u003cspan\u003e$\u003c/span\u003e165\u0026nbsp;billion by 2025 from averted HIV treatment and associated costs \u003csup\u003e[5]\u003c/sup\u003e. With growing awareness of the health benefits of circumcision, an increasing number of parents are opting to have their minor children undergo the procedure \u003csup\u003e[6]\u003c/sup\u003e. Despite the advantages of circumcision, pediatric surgeries, even minor ones, are still stress remains a significant concern for families, often causing considerable stress and anxiety for both the children undergoing the procedure and their parents\u003csup\u003e[7, 8]\u003c/sup\u003e. Consequently, many children and their parents report negative experiences associated with the procedure \u003csup\u003e[8, 9]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAnxiety related to pediatric circumcision is prevalent in both children and their parents \u003csup\u003e[10\u0026ndash;12]\u003c/sup\u003e. A significant cause of this anxiety is the insufficient health education provided to both parties, which results in their inadequate understanding of the procedure\u003csup\u003e[13]\u003c/sup\u003e. Studies have shown that up to 84% of children undergoing circumcision experience fear or anxiety, which can be exacerbated by the uncertainty surrounding the surgery and the postoperative care \u003csup\u003e[14]\u003c/sup\u003e. This anxiety can lead to several negative outcomes, including increased pain, delayed recovery, and a higher incidence of postoperative complications. Moreover, anxiety in children can result in sleep disturbances and behavioral problems, further affecting their overall recovery and well-being \u003csup\u003e[15]\u003c/sup\u003e. It may also lead to prolonged sedation and the need for additional care \u003csup\u003e[16, 17]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eParents, who often take on the caregiver role during the perioperative period of their children, also experience significant anxiety \u003csup\u003e[18\u0026ndash;20]\u003c/sup\u003e. Factors contributing to parental anxiety include concerns about their child\u0026rsquo;s postoperative pain, potential complications, and the uncertainty surrounding the child\u0026rsquo;s recovery \u003csup\u003e[21]\u003c/sup\u003e. The lack of sufficient preoperative knowledge, combined with the stress of managing postoperative care, further exacerbates parental anxiety \u003csup\u003e[22\u0026ndash;24]\u003c/sup\u003e. Furthermore, this inadequate knowledge may hinder parents' ability to effectively manage postoperative care, potentially leading to unnecessary emergency room visits and common postoperative complications such as bleeding, swelling, and adhesions \u003csup\u003e[24\u0026ndash;26]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eGiven these challenges, it is crucial to find effective methods to address the psychological impact of circumcision on both parents and children. Health education interventions have shown promise in reducing preoperative anxiety and promoting a better understanding of the procedure, thus enhancing the overall surgical experience for both parents and children \u003csup\u003e[27, 28]\u003c/sup\u003e. However, traditional health education approaches, such as verbal explanations and printed materials, often fail to address the emotional and informational needs of families effectively \u003csup\u003e[29, 30]\u003c/sup\u003e. These methods can also be overly monotonous, lack clarity, and may result in misunderstandings or information overload \u003csup\u003e[31\u0026ndash;34]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eTwo promising educational approaches are video-based education and the teach-back method. Video education, which is intuitive, concise, and informative, has been shown to improve self-care and reduce anxiety in both children and parents \u003csup\u003e[35\u0026ndash;38]\u003c/sup\u003e. The teach-back method, which involves reinforcing key information through patient interaction, has also been found to improve educational outcomes \u003csup\u003e[39, 40]\u003c/sup\u003e. Studies combining these two methods, especially in the context of circumcision, have demonstrated their ability to alleviate anxiety of patients and improve postoperative recovery \u003csup\u003e[41]\u003c/sup\u003e. For instance, Wang et al. (2023) combined video and teach-back strategies to deliver health education to circumcision patients aged 11\u0026ndash;38 in China, which reduced the incidence of complications and increased patient satisfaction \u003csup\u003e[41]\u003c/sup\u003e. Therefore, implementing a video-based teach-back health education program in circumcision appears both feasible and potentially effective. However, such a combination strategy has not been provided to the parents of circumcised children, and it currently lacks theoretical foundation and a standardized definition. Therefore, it is necessary to develop a theoretically based, innovative, and easily accessible intervention for children undergoing circumcision and their parents.\u003c/p\u003e \u003cp\u003eThe protocol of this study was designed an innovative health education intervention strategy\u0026mdash;Video-based 5Ts Teach-back Health Education (V5TTHE)\u0026mdash;to enhance the surgical experience for both children undergoing circumcision and their parents. The core of this strategy combines video education with the teach-back method, supported by theoretical frameworks. V5TTHE seeks to provide essential knowledge about circumcision to both children and their parents, while also equipping parents with the necessary tools to effectively manage postoperative care. The primary objectives of this intervention are to alleviate anxiety in both children and parents, reduce the incidence of postoperative complications, decrease the rate of unnecessary medical consultations, and increase satisfaction with health education.\u003c/p\u003e"},{"header":"2. Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Aim and Hypotheses\u003c/h2\u003e \u003cp\u003eThis study aims to evaluate the effects of video-based 5Ts teach-back health education on the surgical experiences of circumcised children and their parents, including anxiety levels, postoperative complications, unnecessary medical consultations, and satisfaction with health education.\u003c/p\u003e \u003cp\u003eWe hypothesize that participants in the intervention group will be reported to have the significant differences compared to the control group:\u003c/p\u003e \u003cp\u003e(1) Reduced anxiety in both children and parents;\u003c/p\u003e \u003cp\u003e(2) Fewer postoperative complications in children;\u003c/p\u003e \u003cp\u003e(3) Lower rate of unnecessary medical consultations;\u003c/p\u003e \u003cp\u003e(4) Greater satisfaction with health education regarding circumcision.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Design\u003c/h2\u003e \u003cp\u003eA single-blind, parallel-group, randomized controlled trial (RCT) was designed for the study. The research follows the SPIRIT 2013 Statement and the guidelines for the Standard Protocol of Clinical Trials \u003csup\u003e[42]\u003c/sup\u003e. The Consolidated Standards of Reporting Trial (CONSORT) flowchart is presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003csup\u003e[43]\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Study Setting\u003c/h2\u003e \u003cp\u003eThe study will be conducted at a university-affiliated tertiary public hospital in China, with a pediatric urology subspecialty in the Department of Urology.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Participants\u003c/h2\u003e \u003cp\u003eParticipants who meet the inclusion criteria will be recruited. The inclusion criteria are: (1) Children undergoing their first male circumcision, along with their parents; (2) Children aged 6\u0026ndash;15 years \u003csup\u003e[44]\u003c/sup\u003e; (3) Children and parents who can complete the task of watching the video. The exclusion criteria are: (1) A history of depression; (2) Children or parents with serious physical or mental illness, such as cancer, severe depression, or congenital heart disease; (3) Undergoing psychotherapy or any other physical or psychological intervention.\u003c/p\u003e \u003cp\u003eThe sample will be estimated based on previous studies with a medium effect size \u003csup\u003e[33]\u003c/sup\u003e. With a power of 0.80, an alpha set at 0.05, and an effect size of 0.5 for the primary outcome of The Screen for Child Anxiety Related Emotional Disorders (SCARED) \u003csup\u003e[45]\u003c/sup\u003e, each group will be 64 participants. We estimate a 10% attrition rate, requiring a minimum of 144 participants (72 per group). Each parent-child dyad will be treated as a single unit of recruitment.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e2.5 Recruitment\u003c/h2\u003e \u003cp\u003eParticipants will be recruited when children are admitted to the urology outpatient clinics or wards in hospitals. Nurses will introduce the trial to children and parents who meet the inclusion criteria. The children and their parents who verbally agree to participate will be approached by the researchers to provide them with an information sheet and to answer any questions about the research. If both the child and the parents are willing to participate, they will be asked to sign an informed consent form and be informed of freedom to withdraw whenever they want.\u003c/p\u003e \u003cp\u003eData will be collected before randomization (baseline), one week after surgery (test 1), and two weeks after surgery (test 2). Recruitment of participants began in January 2025. Primary endpoints (baseline and test 1) and follow-up measures (test 2) will be expected to be completed by October 2025.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e2.6 Randomization and Blinding\u003c/h2\u003e \u003cp\u003eParticipants will be randomly assigned to the intervention or control group with a 1:1 allocation ratio. Sequence randomization will be performed using a computerized random number generator, with the results stored in a sealed and opaque envelope. Blinding will not be possible for the researchers during the study; however, group allocation will remain masked until baseline data are complete. Outcome assessors and data analysts will be blinded to group allocation throughout the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e2.7 Intervention\u003c/h2\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003e2.7.1 control group\u003c/h2\u003e \u003cp\u003eThe children and parents in the control group will receive routine health education, which includes three sessions of pediatric circumcision health education: before surgery, immediately after surgery, and before discharge. The third health education session for families of outpatient surgery patients will be rescheduled from pre-discharge education to the one-week postoperative follow-up visit. The educational content includes.\u003c/p\u003e \u003cp\u003e (1) preoperative education on psychological care and preparation; (2) postoperative education on wound care, pain management, dietary care, and daily living; and (3) discharge guidance on wound care, dietary recommendations, activity guidelines, complications awareness, and review reminders. During these sessions, the nurses will address any questions from participants regarding circumcision. If no questions are raised, the session will be concluded. Researchers and urology specialist nurses at the hospital will be responsible for delivering the intervention. The children and their parents will receive two follow-up visits. Face-to-face visits will be the preferred method. However, families who are unable to return to the hospital will be followed up through WeChat or phone. The follow-up visits will be conducted at the time of the one-week postoperative review. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e describes the interventions in detail.\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 \u003cp\u003eThe details of the intervention\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\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 \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl Group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntervention Group\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eService\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRoutine health education\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eV5TTHE\u0026thinsp;+\u0026thinsp;Routine health education\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlace\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHospital, home\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHospital, home\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eForm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFace-to-face oral communication\u003c/p\u003e \u003cp\u003ePhone communication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFace-to-face and Video\u003c/p\u003e \u003cp\u003ePhone and WeChat\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProvider\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResearchers and urology specialist nurses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eResearchers\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eContents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRoutine health education\u003c/p\u003e \u003cp\u003evisiting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePerception, judgment, action, and evaluation\u003c/p\u003e \u003cp\u003evisiting\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePreoperative, postoperative and pre-discharge\u003c/p\u003e \u003cp\u003eEach health education takes 15\u0026ndash;20 minutes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePreoperative, postoperative and pre-discharge\u003c/p\u003e \u003cp\u003eEach health education takes 15\u0026ndash;20 minutes\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAssessment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eBaseline (pre-intervention)\u003c/p\u003e \u003cp\u003etest 1 ( 1 week after operation )\u003c/p\u003e \u003cp\u003etest 2 ( 2 weeks after operation )\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBaseline (pre-intervention)\u003c/p\u003e \u003cp\u003etest 1 ( 1 week after operation )\u003c/p\u003e \u003cp\u003etest 2 ( 2 weeks after operation )\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e \u003ch2\u003e2.7.2 Intervention group\u003c/h2\u003e \u003cp\u003e The children and parents in the intervention group will receive video-based 5Ts teach-back health education (V5TTHE) in addition to routine health education. The V5TTHE method was developed using the theoretical framework incorporated King's Theory of Goal Attainment and Feedback Theory \u003csup\u003e[46, 47]\u003c/sup\u003e. Sound evidence identified that child and parent anxiety and the child's postoperative complications are essential components to affect their disease experience \u003csup\u003e[48]\u003c/sup\u003e. V5TTHE is designed to reduce anxiety in both children and parents, decrease the incidence of postoperative complications to lower the rate of unnecessary medical consultations and increase satisfaction, then help families navigate the perioperative period and smooth recovery.\u003c/p\u003e \u003cp\u003eThe core of King's Theory of Goal Attainment is the achievement of goals through the interaction, transaction, and communication between nurses and patients \u003csup\u003e[46]\u003c/sup\u003e. In practice, both parties attain interaction, transaction, and goal attainment through the cyclical process of \"perception\u0026mdash;judgment\u0026mdash;action\u0026mdash;reaction \u003csup\u003e[49]\u003c/sup\u003e.\" King's Theory of Goal Attainment has been shown to enhance the patient's comprehension and retention of health-related knowledge, thereby improving recovery outcomes and increasing patient satisfaction \u003csup\u003e[50\u0026ndash;52]\u003c/sup\u003e. The feedback theory refers to the process by which a system returns output information as part of the input information to adjust and control the system \u003csup\u003e[47]\u003c/sup\u003e. The theory aligns with the concept of King\u0026rsquo;s Theory of Goal Attainment, which similarly improves the outcomes of health education \u003csup\u003e[53, 54]\u003c/sup\u003e. In this study, V5TTHE follows the three steps of perception, judgment, and action from the Theory of Goal Attainment, with the reaction step represented through the cycle of evaluation and reconstruction. The feedback theory runs through the action phase, manifested as the participants' teach-back and the researchers' subsequent teaching. The entire process of V5TTHE aligns with the core principles of both theories, promoting learning outcomes through continuous interaction and cycles (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe perception stage is the initial phase of the intervention. It begins with formal introductions and in-depth communication between the researchers, children, and parents. This phase aims to establish trust and rapport, which are crucial for the success of the intervention. The researchers will employ a range of methods to assess the children's and parents' understanding, including direct communication, situational assessments, questionnaires, and standardized scale evaluations. The judgment stage involves researchers and parents collaboratively setting goals based on the assessment results and identifying key learning objectives. In the judgment stage, researchers and parents need to collaboratively set learning goals based on the assessment results. Researchers will determine the learning priorities for each individual during the subsequent feedback stage, based on their specific circumstances.\u003c/p\u003e \u003cp\u003eIn the action phase, parents in the intervention group will be asked to watch the health education video. Following the viewing, they will begin the feedback process. This process requires parents to articulate the knowledge they have learned by answering the researchers' questions in their own words. If parents provide incorrect or incomplete responses, they will receive further detailed explanations from the researcher. The session will be considered complete when the parents have demonstrated full comprehension of the educational content. Each intervention session will last 15\u0026ndash;20 minutes.\u003c/p\u003e \u003cp\u003eThe \"5T\" principle will be followed throughout the action phase. It is derived from the \"5Ts Teach-back\" method, a health communication strategy developed by Catherine M.\u0026rsquo;s team \u003csup\u003e[55]\u003c/sup\u003e. It includes five steps: Triage, Tool, Take Responsibility, Tell me, and Try again. (1)Triage: In this step, researchers will identify the key educational priorities for each participant based on individual needs. This step is crucial in preventing information overload for the learner. (2)Tools: The primary tool used in this study will be video. Both children and parents can reinforce the knowledge at any time and in any location, enabling flexible and continuous learning. The V5TTHE videos will feature visual elements of the hospital environment and medical equipment to explain the health knowledge related to pediatric circumcision. These elements are designed to alleviate discomfort stemming from the unfamiliar hospital setting, while simultaneously enhancing children's trust and reducing their anxiety about the procedure. Key nursing procedures, such as wound care and postoperative guidance, will be demonstrated in these videos using models. This approach allows parents to visually observe the procedures involved in their child's recovery, making it easier for them to learn and apply the necessary care techniques. In addition, the videos are designed with storylines featuring questions commonly asked by parents. Solving the problems, through embedded storytelling, will encourage active learning and ensure that the viewers feel their specific needs are being addressed. Finally, to further engage viewers and improve comprehension, the videos will be supplemented with explanatory text, animations, and background music. To ensure the audience can easily grasp complex concepts, simple language will be provided as a substitute for technical medical terms.\u003c/p\u003e \u003cp\u003e(3)Take Responsibility: This step occurs after the learner receives the information. The ideal Take Responsibility line contains two elements. The first is an acknowledgment of the quantity or complexity of the information given. This normalizes misunderstandings if they do occur, thereby reducing shame for the learner. For example, the researcher can say, \"The amount of information shared today is quite large; it's normal if it\u0026rsquo;s hard to remember everything.\" Secondly, the step emphasizes that parents and children are participants in the learning process rather than patients, which helps reduce their stress. (4)Tell Me: In this phase, researchers will ask parents to express what they have learned in their own words. For example, after showing a video on postoperative care, the researcher may ask, \"What do you understand about wound care after circumcision?\" In such situations, the large amount of information may leave parents uncertain about where to begin their response. However, a more specific Tell Me line, such as, \u0026ldquo;What would you do if your child experiences wound bleeding?\u0026rdquo; This method enables both educators and learners to focus on specific information points, thereby allowing a more accurate assessment of the learner's comprehension of the material. (5)Try Again: If the parents do not understand, they will receive further clarification, possibly through a different explanation. Depending on the extent of misunderstanding, another round of teaching may be necessary. In the meantime, the researcher can also return to the \"Take Responsibility\" step, apologizing for any unclear explanations, thereby reducing feelings of shame or discomfort parents may have regarding their misunderstanding.\u003c/p\u003e \u003cp\u003eFinally, the evaluation stage will take place. During this phase, the researchers will assess whether the learning objectives have been achieved by both the child and the parents. If the objectives are met, the intervention will conclude. If the objectives are not met, the reasons for the shortcomings will be analyzed, and the intervention plan will be adjusted accordingly until the learning goals are successfully achieved.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003e2.8 Measures\u003c/h2\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003e2.8.1 Primary Outcome\u003c/h2\u003e \u003cp\u003e(1) Anxiety in children and parents\u003c/p\u003e \u003cp\u003eAnxiety in children undergoing circumcision will be assessed using the Chinese version of The Screen for Child Anxiety Related Emotional Disorders (SCARED) \u003csup\u003e[45]\u003c/sup\u003e. The 41-item tool utilizes a 3-point Likert score from 0 (never) to 2 (often). A total score of \u0026ge;\u0026thinsp;23 indicates a likelihood of anxiety, with higher scores indicating more severe anxiety symptoms. The internal consistency of the Chinese version of SCARED has been reported as 0.89, with a test-retest reliability coefficient of 0.77 \u003csup\u003e[56]\u003c/sup\u003e. Additionally, the scale demonstrates good discriminant validity, distinguishing between anxiety and non-anxiety disorders \u003csup\u003e[56]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe Chinese version of the State-Trait Anxiety Inventory (STAI) will be used to measure anxiety in the parents of the children \u003csup\u003e[57]\u003c/sup\u003e. The STAI consists of 40 items divided into two sections: state anxiety (a transient emotional state) and trait anxiety (a relatively stable anxious personality trait). Each item is rated on a 1\u0026ndash;4 scale, with higher scores indicating higher levels of anxiety. The STAI (two parts) has demonstrated good reliability and validity. The Cronbach\u0026rsquo;s alpha coefficients for the two parts were 0.87 and 0.84, the test-retest reliabilities were 0.73 and 0.81, and the Pearson correlation coefficient for the Chinese version was 0.97 \u003csup\u003e[58]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003e(2) Incidence of post-circumcision complications (IPCC)\u003c/p\u003e \u003cp\u003eThe IPCC is defined as the percentage of patients who experience complications following circumcision. The criteria for assessing complications are based on physicians' clinical experience as well as the \"Chinese Guidelines for the Diagnosis and Treatment of Urological Diseases\" \u003csup\u003e[59]\u003c/sup\u003eand the \"Expert Consensus on Phimosis, Redundant Prepuce, and Prepuce-Related Diseases\" \u003csup\u003e[1]\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section3\"\u003e \u003ch2\u003e2.8.2 Secondary Outcome\u003c/h2\u003e \u003cp\u003e(1) Proportion of unnecessary postoperative visits (PUPV)\u003c/p\u003e \u003cp\u003eThis outcome includes both online and offline visits. Unnecessary postoperative visits are defined as non-urgent or unnecessary medical and nursing care sought by patients \u003csup\u003e[60\u0026ndash;62]\u003c/sup\u003e. The PUPV will be calculated as the ratio of unnecessary visits to the total number of visits over a specified period. A multidisciplinary team, including doctors, nurses, and other healthcare professionals, will assess whether a visit is unnecessary. The assessment will consider factors such as the timing and reason for the visit, symptoms, and diagnosis, which will be derived from the hospital's electronic medical records system and patient follow-up data.\u003c/p\u003e \u003cp\u003e(2) satisfaction with health education:\u003c/p\u003e \u003cp\u003eParents' satisfaction with health education will be assessed with a 3-item questionnaire developed by the researchers. The items are \u0026ldquo;Overall, how satisfied with the health education you received?\u0026rdquo;, \u0026ldquo;Please give your reasons\u0026rdquo;, and \"Please give your advice\". A 5-point Likert scale (1\u0026thinsp;=\u0026thinsp;very dissatisfied, 2\u0026thinsp;=\u0026thinsp;dissatisfied, 3\u0026thinsp;=\u0026thinsp;moderately satisfied, 4\u0026thinsp;=\u0026thinsp;satisfied, 5\u0026thinsp;=\u0026thinsp;very satisfied) will be used to assess the overall satisfaction.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003e2.9 Data Collection\u003c/h2\u003e \u003cp\u003eBaseline assessments will be conducted by the study team. Participants will be asked to complete the SCARED, the STAI, and a social-demographic and clinical data questionnaire during their visit to the urology outpatient clinic or ward. Follow-up assessments will take place at two time points: one week and two weeks post-surgery. At these two follow-up assessments (Test 1 and Test 2), the researcher will administer the SCARED and the STAI to participants in a face-to-face setting, instructing them to complete the scales. Additionally, at Test 2, participants will be asked to fill out a health education satisfaction questionnaire and report any complications or unnecessary postoperative visits. In cases where participants are unable to return to the hospital for in-person assessments, an electronic version of the questionnaire will be sent via WeChat or email, with the completed form returned in the same manner. To enhance adherence to the study protocol, ensure participant retention, and support complete follow-up, participants will receive online reminders before each scheduled assessment. Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e shows the study variables and assessment time points.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThe study variables and assessment time points\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\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 \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c2\" namest=\"c1\" rowspan=\"2\"\u003e \u003cp\u003eVariables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e \u003cp\u003eTime point\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBaseline (T0)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 week after operation (T1)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 week after operation (T2)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"1\" nameend=\"c6\" namest=\"c6\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSocial-demographic\u003c/p\u003e \u003cp\u003eand clinical data\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"1\" nameend=\"c6\" namest=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ePrimary Outcome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eThe anxiety of children and parents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"1\" nameend=\"c6\" namest=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIncidence of complications\u003c/p\u003e \u003cp\u003eafter circumcision\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"1\" nameend=\"c6\" namest=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eSecondary Outcome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnnecessary visits\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"1\" nameend=\"c6\" namest=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePatient or parent satisfaction\u003c/p\u003e \u003cp\u003ewith health education\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"1\" nameend=\"c6\" namest=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003e2.10 Data Analysis\u003c/h2\u003e \u003cp\u003eData will be analyzed using the Statistical Package for Social Sciences (SPSS 29.0). An intent-to-treat (ITT) analysis will be employed to handle missing data. Descriptive statistics will be used to summarize the social-demographic and clinical characteristics, including means, standard deviations (SDs), frequencies, and percentages. The Chi-square (Χ\u0026sup2;) test for categorical variables and independent sample t-tests for continuous variables will be used to identify significant differences in social-demographic and clinical characteristics, as well as baseline outcomes, between the control and intervention groups. The effect of the intervention on reduced anxiety in circumcised children and their parents across the three points will be evaluated via repeated measures multivariate analysis of covariance to explore how outcomes have changed between groups, over time, and the interaction between groups and time. The incidence of circumcision complications and unnecessary postoperative visits between the two groups will be compared using chi-square tests. The independent t-test will be used to compare satisfaction with health education between the intervention group and the control group.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Validity and Reliability","content":"\u003cp\u003eThe study adopts a rigorous research design, grounded in a solid theoretical framework, and utilizes tools with established reliability and validity. The RCT is supported by an adequate and representative sample, ensuring the robustness and generalizability of the findings. Recruitment and randomization procedures will adhere to strict protocols to minimize selection bias while ensuring complete random allocation. To reduce the potential for bias, all researchers involved in the intervention delivery will undergo standardized training, which will help mitigate the Hawthorne effect. Additionally, outcome assessors and data analysts will remain blinded to group allocation throughout the study to further reduce biases in evaluating the effects of the intervention.\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003e To our knowledge, this study will be the first RCT to employ the video-based 5Ts Teach-back method for health education targeting both children undergoing circumcision and their parents. On one hand, V5TTHE may alleviate both the physical and psychological burdens experienced by children and their parents, potentially reducing the need for unplanned medical care. On the other hand, the flexibility and time efficiency of video education could make it an attractive alternative for families facing location or time constraints in attending traditional in-person health education sessions. If this study proves effective, it will provide valuable insights into the role of health education in enhancing children's and parents' understanding of pediatric circumcision, and contribute to alleviating their anxiety and improving postoperative care for the children. Even if the results are null, parents will gain a deeper understanding of circumcision-related health education, which may help reduce healthcare disparities and promote equity in education.\u003c/p\u003e \u003cp\u003eHowever, some limitations need to be noted in the research. First, due to the study design, blinding of researchers during all phases of the study will not be feasible, which may introduce potential bias. Second, the reliance on parents to report anxiety levels for their children may introduce reporting bias, especially if children are unable to independently complete the anxiety scale for various reasons. Finally, due to time and financial constraints, we will be unable to conduct extended follow-up assessments, which limits our ability to determine the long-term persistence of surgical anxiety and its potential impact on the children\u0026rsquo;s post-operative life.\u003c/p\u003e"},{"header":"5. Conclusions","content":"\u003cp\u003eThe research will contribute to evidence on the effectiveness of implementing health education to support circumcised children and their parents. By combining video-based education with the Teach-back method, this innovative intervention holds promise for improving both the physical and psychological well-being of the children and parents, reducing the need for unplanned medical visits, and increasing satisfaction with health education. If successful, the V5TTHE intervention could be integrated into clinical practice, offering significant benefits for both patients and healthcare providers by improving the overall disease experience and alleviating the burden of health education on clinical staff. Moreover, this intervention could serve as a model for future research and interventions, such as designing culturally appropriate health education programs for families of children undergoing circumcision in different countries.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eRCT \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Randomized controlled trial\u003c/p\u003e\n\u003cp\u003eHSV-2 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Herpes simplex virus type 2\u003c/p\u003e\n\u003cp\u003eHPV \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Human papilloma virus\u003c/p\u003e\n\u003cp\u003eV5TTHE \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Video-based 5Ts Teach-back Health Education\u003c/p\u003e\n\u003cp\u003eCONSORT \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Consolidated Standards of Reporting Trial\u003c/p\u003e\n\u003cp\u003eSCARED \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Screen for Child Anxiety Related Emotional Disorders\u003c/p\u003e\n\u003cp\u003eSTAI \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; State-Trait Anxiety Inventory\u003c/p\u003e\n\u003cp\u003eIPCC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Incidence of post-circumcision complications\u003c/p\u003e\n\u003cp\u003ePUPV \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Proportion of unnecessary postoperative visits\u003c/p\u003e\n\u003cp\u003eITT \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Intent-to-treat\u003c/p\u003e\n\u003cp\u003eSDs \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Standard deviations\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch4\u003eAuthors\u0026apos; contributions\u003c/h4\u003e\n\u003cp\u003eConceptualization: JL, JTOY; Design of the study: JL, BW; Draft of the manuscript: JL, XJ Z; Preparation of the study: JL, JTOY, JC, JLW; substantial revisions of the manuscript: JL, JTOY, BW, XJZ, JC, JLW. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003ch4\u003eFunding\u003c/h4\u003e\n\u003cp\u003eXujuan Zheng (X.Z.) was supported by the General Program of Stable Support Plan for Universities in Shenzhen City (grant no. 20200804101756002).\u003c/p\u003e\n\u003ch4\u003eAcknowledgements \u0026nbsp;\u003c/h4\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch4\u003eAvailability of data and materials\u003c/h4\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch4\u003eEthics approval and consent to participate\u003c/h4\u003e\n\u003cp\u003eThe study has been approved by the Science and Technology Ethics Committee of Shenzhen University General Hospital (Approval No. KYLL-20241104A). Its registration number with the Chinese Clinical Trial Registry is ChiCTR2400093255. This research will adhere to the ethical standards of the Declaration of Helsinki throughout the study. Informed consent will be obtained from all participants or their guardians prior to baseline data collection. There are no potential risks or harms to participating in this study. Children will not be deprived of any routine care and treatment. All participant information will remain confidential.\u003c/p\u003e\n\u003ch4\u003eConsent for publication \u0026nbsp;\u003c/h4\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003ch4\u003eCompeting interests\u003c/h4\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eChinese Expert Consensus on Phimosis, Excessive Prepuce, and Prepuce-Related Diseases [J]. National Journal of Andrology, 2021, 27(09): 845\u0026thinsp;\u0026minus;\u0026thinsp;52.\u003c/li\u003e\n\u003cli\u003eBERNASCHINA-RIVERA S A, L\u0026oacute;PEZ-CHAIM A I, CORDERO-PACHECO J A, et al. Circumcision and Sexual Medicine [J]. 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Health Lit Res Pract, 2020, 4(2): e94-e103.\u003c/li\u003e\n\u003cli\u003eSU L, WANG K, FAN F, et al. Reliability and validity of the screen for child anxiety related emotional disorders (SCARED) in Chinese children [J]. Journal of Anxiety Disorders, 2008, 22(4): 612\u0026thinsp;\u0026minus;\u0026thinsp;21.\u003c/li\u003e\n\u003cli\u003eMARTEAU T M, BEKKER H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI) [J]. Br J Clin Psychol, 1992, 31(3): 301-6.\u003c/li\u003e\n\u003cli\u003eDU Q, LIU H, YANG C, et al. The Development of a Short Chinese Version of the State-Trait Anxiety Inventory [J]. Front Psychiatry, 2022, 13: 854547.\u003c/li\u003e\n\u003cli\u003eGuidelines for the Diagnosis and Treatment of Urological Diseases in China (2011 Edition) was published [J]. Journal of Urology for Clinicians(ElectronicVersion), 2011, (3): 54.\u003c/li\u003e\n\u003cli\u003eMORRIS T, MASON S M, MOULTON C, et al. 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BMJ Qual Saf, 2020, 29(6): 449\u0026thinsp;\u0026minus;\u0026thinsp;64.\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":"Circumcision, health education, Teach-back, anxiety","lastPublishedDoi":"10.21203/rs.3.rs-6156186/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6156186/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003ePediatric circumcision is widely performed. However, both children and their parents still face issues of surgical anxiety and negative surgical experience, which adversely affect family life. Health education has shown potential in improving these situations. However, existing health education programs primarily focus on children rather than both children and their parents, and these programs lack theoretical support. This study aims to develop an innovative health education strategies to address these issues effectively.\u003c/p\u003e\u003ch2\u003eAim\u003c/h2\u003e \u003cp\u003eTo evaluate the effects of video-based 5Ts Teach-back health education for circumcised children and their parents in terms of reducing anxiety, postoperative complications, and unnecessary postoperative visits; and improving satisfaction with overall health education.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis study will use a single-blind, parallel-group randomized controlled trial (RCT) design. 144 participants will be enrolled, with one parent-child pair considered as one dyad. Based on King\u0026rsquo;s Theory of Goal Attainment and the Feedback Theory, the video-based 5Ts teach-back method consists of four steps: (a) Perception, (b) Judgment, (c) Action, and (d) Evaluation. Circumcised children and their parents will be recruited from the urology clinic or ward of a university-affiliated hospital in China. The participants will be randomly assigned to the intervention group (N\u0026thinsp;=\u0026thinsp;72), which will receive the video-based 5Ts teach-back method before and one week after surgery, and the control group (N\u0026thinsp;=\u0026thinsp;72) which will receive routine health education. Anxiety, postoperative complications, unnecessary postoperative visits, and satisfaction with health education will be measured at baseline, 1 week after surgery (Test 1), and 2 weeks after surgery (Test 2).\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eIf effective, the intervention will offer a convenient and impactful health education program for circumcised children and their parents; and could become the routine health education for healthcare professionals to improve the child's postoperative recovery and the family's mental well-being. As the first RCT to test the effects of the video-based 5Ts Teach-back method for families of circumcised children in China, the results will provide evidence-based insights for health education on pediatric circumcision and reduce the educational burden on clinical nurses.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eChiCTR2400093255. Date of registration: 29 November 2024\u003c/p\u003e","manuscriptTitle":"Implementing Video-Based 5Ts Teach-back Health Education in pediatric circumcision to improve surgical experience in children and their parents: Study protocol for a randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-11 07:05:41","doi":"10.21203/rs.3.rs-6156186/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":"e23db3d0-566c-4189-afd8-01ced575060f","owner":[],"postedDate":"March 11th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-11-12T09:09:55+00:00","versionOfRecord":[],"versionCreatedAt":"2025-03-11 07:05:41","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6156186","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6156186","identity":"rs-6156186","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}