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

February 16, 2026 updated by: Duygu Sonmez Duzkaya, Tarsus University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yusuf Kızılkaya

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged between 4 and 10 years
  • Having undergone abdominal surgery
  • Having undergone surgery under general anesthesia
  • Having received a single dose of analgesic (paracetamol) after surgery
  • Having undergone initial mobilization after surgery
  • Volunteering to participate in the study

Exclusion Criteria:

  • Previous surgical intervention
  • Major surgery
  • Chronic illness
  • The child has visual, hearing, and mental disabilities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toy Group
The incision sites of children in this group will be supported with a plush toy immediately before the procedure begins and will continue to be supported throughout mobilization. When the patient is transferred to the hospital bed, the support with the plush toy will be discontinued.
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.
No Intervention: Control Group
Children in this group will receive parental support as part of the clinic's routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children Information Form
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.
1 day
Wong-Baker Pain Scale
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.
1 day
Fear Scale
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Kwekkeboom, K. L., & Gretarsdottir, E. (2006). Systematic review of relaxation interventions for pain. Journal of nursing scholarship, 38(3), 269-277.
  • Jones, R. A., Merkle, S., Ruvalcaba, L., Ashton, P., Bailey, C., & Lopez, M. (2020). Nurse-led mobility program: driving a culture of early mobilization in medical surgical nursing. Journal of Nursing Care Quality, 35(1), 20-26.
  • Gürsoy, A. (2024). Video destekli erken mobilizasyon eğitiminin abdominal cerrahi sonrası hastaların mobilizasyon durumuna ve mobilizasyon ile ilişkili ölçütlere etkisi (doktora tezi). Karadeniz Teknik Üniversitesi.
  • Gıynaş, T., Önel, A. E., Küçük, S., Uğur, S., & Yardımcı, F. An Investigation of Using Non-Pharmacological Methods in Pain Management in Postoperative Period in Children: A Systematic Review. Bilecik Şeyh Edebali Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 2(3), 172-190.
  • Daldaban, F. N. (2023), Erken mobilizasyon eğitiminin abdominal cerrahi sonrası hareketlilik, ağrı ve konfor üzerine etkisi (yüksek lisans tezi). Doğu Akdeniz Üniversitesi.
  • Çamok, G. (2021). Yoğun bakım ünitesinde entübe hastaların erken mobilizasyonu ve erken mobilizasyonun solunum örüntüsü ile hasta hemodinamisine etkileri (yüksek lisans tezi). İstanbul Okan Üniversitesi.
  • Cote, C. J., & Wilson, S. (2016). Guidelines for monitoring and management of pediatric patients before, during, and after sedation for diagnostic and therapeutic procedures: update 2016. Pediatric Dentistry, 38(4), E19-E39. https://doi.org/10.1542/peds.2016-1212
  • Christiaens, G. (2003). Independent nursing interventions for pain management. Home health care management & practice, 15(3), 212-214.
  • Akdağ, Y. M. (2019). Akut apendisit ameliyatı olan 6-12 yaş grubu çocukların postoperatif dönemde çevre oyunu ile mobilizasyonunun korku ve ağrı düzeyine etkisi (Yüksek lisans tezi). İstanbul Okan Üniversitesi.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026/03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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