NCT07428421

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

Abdominal Surgerypediatricnursingtoy

Outcome Measures

Primary Outcomes (3)

  • Children Information Form

    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

    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

    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

Study Arms (2)

Toy Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Children in this group will receive parental support as part of the clinic's routine.

Interventions

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.

Toy Group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • Kwekkeboom, K. L., & Gretarsdottir, E. (2006). Systematic review of relaxation interventions for pain. Journal of nursing scholarship, 38(3), 269-277.

    BACKGROUND
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • Daldaban, F. N. (2023), Erken mobilizasyon eğitiminin abdominal cerrahi sonrası hareketlilik, ağrı ve konfor üzerine etkisi (yüksek lisans tezi). Doğu Akdeniz Üniversitesi.

    RESULT
  • 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.

    RESULT
  • 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

    RESULT
  • Christiaens, G. (2003). Independent nursing interventions for pain management. Home health care management & practice, 15(3), 212-214.

    RESULT
  • 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.

    RESULT

Central Study Contacts

Duygu SÖNMEZ DÜZKAYA, PhD

CONTACT

Yusuf Kızılkaya

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations