Tarsus University
Mersin, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07428421
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.
Interested in participating?
Request Info4 year–10 year
All sexes
Interventional
Not applicable
Mersin, Turkey (Türkiye)
Location status: Recruiting
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.
In this phase:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 day
The form, prepared in line with the literature, consists of 24 questions regarding the sociodemographic characteristics of children. A 3-point Likert-type observation form created by the researcher will be used in this form to evaluate children's participation in the mobilization process. Scoring is categorized as follows: '3: Willing/Active Participation', '2: Reluctant/Variable Participation', and '1: Unwilling/Resistant'. The researcher observed the child's verbal and behavioral responses during mobilization preparation and the walk and assigned the relevant score.
Time frame: 1 day
Developed in 1981 by Donna Wong and Connie Morain Baker to assess children's pain levels, it was revised in 1983. There are six facial expressions scored from zero to ten. The Wong-Baker Scale features faces that show increasing pain intensity from zero to six, moving from left to right.
Time frame: 1 day
Thurillet et al. (2022) developed this scale to assess children's fears based on self-reports from children aged 4-12. The Turkish validity and reliability study was conducted by Tavşan et al. (2024). The scale consists of six facial expressions. The scale rates fear on a scale ranging from 0 to 10 (rated incrementally in twos), consistent with pain rating scales. The first facial expression indicates no fear, while fear increases as one moves from right to left, with the sixth facial expression indicating the highest level of fear. A statistically significant, very high positive correlation was found between the Fear Scale and the Children's Fear Scale (r=0.973; p<0.001). The high correlation value between the two forms indicates that the children's form is valid. The scale's content validity index and item content validity index values were found to be 0.98. A very good level of statistically significant agreement was found between the Fear Scale and the Children's Fear Scale (Kappa
Contact information is provided by the study sponsor or research team.
Tarsus University
Other
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
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