NCT07428421

The Effect of Supporting the Incision Site With Toys During Mobilization in Children Aged 4-10 Years Undergoing Abdominal Surgery

The Effect of Supporting the Incision Site With Toys During Mobilization on Pain and Fear Levels in Children Aged 4-10 Years Undergoing Abdominal Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Tarsus University · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

Summary

Aim: The aim of this study is to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery. Method: The study was a randomised controlled trial. The study sample consisted of 74 children (Toy: 37, control: 37) who has undergone abdominal surgery between March 2026 and December 2026 at the Mersin University Hospital Pediatric surgery department. The data collection tools used will be the Children Information Form, Wong Baker Pain Scale , Fear scale. In the intervention group, toy will be used after surgery, while the control group will receive routine care. The chils' pain and fear levels will be assessed by the nurse before and after the procedure.

Detailed description

The study will be conducted as a randomized controlled trial to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery. Materials and Methods Setting The research will be conducted at the Pediatric Surgery Department of Mersin University Hospital between March and December 2026. The Pediatric Surgery Department is where elective day surgeries and emergency surgical interventions are performed, and where pre- and post-operative care is provided. Sample When determining the sample size for the study, the scientific study titled "The Effect of Mobilization with Environmental Play on Fear and Pain Levels in the Postoperative Period of Children Aged 6-12 Years Who Underwent Acute Appendectomy" by Akdağ (2019), based on literature reviews to determine the sample size for effect size, was used as a basis. According to the study, the Power analysis (G\*Power 3.1.9.2) resulted in an effect size of 0.896, a 95% confidence interval, and a 95% power, requiring a total of 68 children, with at least 34 in each group. Considering the possibility of dropouts and confounding variables during the research process, a total of 74 children were determined, with 37 children in each group. Data Collection The necessary ethics committee and institutional approvals will be obtained before starting the research. 1. Phase: Data collection forms to be used prior to the research will be pilot tested with 10 children to assess the suitability of the plush toy selected for support. 2. Phase: The children and family members in the sample group will be informed about how the application will be carried out and about the research, and written consent will be obtained from the family and verbal consent from the child. 3. Phase: Children meeting the sample selection criteria will be randomly and equally distributed into two groups (1st study group and 2nd control group) using a computer program to ensure randomization. "(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html)". 4. Phase: The pain and fear levels of children in all groups prior to mobilization will be assessed by the child, parent, and nurse. The child's vital signs will be recorded by the nurse prior to mobilization. In this phase: * Study group: Children in this group will be supported with a plush toy immediately before the incision sites are treated and will continue to be supported throughout mobilization. When the child is transferred to the hospital bed, the support with the plush toy will be discontinued. * Control group: Children in this group will receive the parent support that is routine in the clinic. 5. Step: After mobilization, the child's pain and fear levels will be assessed and recorded by the child, parent, and nurse. After mobilization, the nurse will record the child's vital signs. 6. Step: The data obtained will be analyzed and reported. STATISTICAL ANALYSIS The Statistical Package for Social Sciences (SPSS) version 25.0 will be used to evaluate the data obtained from the research. Descriptive statistics such as frequency, percentage, and arithmetic mean will be used in the analysis of sociodemographic data. For data with a normal distribution, an independent t-test will be used to compare quantitative data between two independent groups, while analysis of variance will be used for repeated measurements when comparing more than two dependent groups. If a difference is found, Bonferroni will be used to identify the group causing the difference. For non-normally distributed data, the Mann Whitney U test will be applied to compare quantitative data between two independent groups, and the Friedman test will be applied when comparing more than two dependent groups. If a difference is found, the adjusted Bonferroni test will be used to identify the group causing the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in the inter-observer agreement analysis. In addition, at the end of the study, the adequacy of the sample size will be tested with a post-hoc power analysis. The statistical significance level will be set at p\<.05.

Conditions

• Child

Interventions

Type	Name	Description
OTHER	Toy Group	Children in this group will be supported with a plush toy immediately before the incision sites are processed and will continue to be supported throughout mobilization. When the child is transferred to the hospital bed, the support with the plush toy will be discontinued. Children in this group will receive parental support as part of the clinic's routine.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-15
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Turkey (Türkiye)