NCT07342751

Brief Summary

This research is designed to improve the mobilization process in children aged 4-6 years undergoing abdominal surgery. The main objective of the study is to determine the effect of music listening on pain and fear levels in children who are standing up for the first time after surgery using a randomized controlled experimental method. This study, to be conducted at the Pediatric Surgery Department of Aksaray Training and Research Hospital, will involve a total of 74 children (37 in the study group and 37 in the control group) between January 2026 and November 2026. According to the research protocol, children in the study group will listen to music of their own choosing during mobilization, while children in the control group will receive routine parental support from the clinic. During the data collection process, children's pain levels will be recorded using the Wong-Baker Pain Scale, and their fear levels using the Child Fear Scale, along with assessments from the child, parent, and nurse. Vital signs such as heart rate and respiratory rate will also be monitored before and after the procedure. This study aims to facilitate early mobilization in children and provide evidence as an effective non-pharmacological method in nursing care.

Trial Health

75
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 pain

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

January 6, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

PainSurgeryChildren, Only

Keywords

painmobilisationsurgerychildren

Outcome Measures

Primary Outcomes (2)

  • The Wong-Baker Scale

    The Wong-Baker Scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983 to assess children's pain levels. It features six facial expressions scored from zero to five. The Wong-Baker Scale includes faces representing increasing pain intensity from zero to five, from left to right.

    1 day

  • Fear Scale

    Developed by McMurtry et al. in 2011, it is a scale used to determine the anxiety/fear levels of children. The scale uses five picture faces. Fear level is evaluated with numbers between '0' and '4'. The first picture represents a score of '0', meaning 'no fear felt', and the fifth picture represents a score of '4', meaning 'severe fear'. As the score increases, the level of fear also increases (McMurtry et al., 2011; 780-788; Gerçeker et al., 2018:9-13). The translation and reliability study of the Child Fear Scale into Turkish was carried out by Özalp Gerçeker and colleagues in 2017.

    1 day

Study Arms (2)

music

EXPERIMENTAL

Children in this group will be played their preferred and favorite music immediately before the mobilization process begins. The music will continue uninterrupted throughout the mobilization process and will end when the child returns to their bed after mobilization.

Other: music

control

NO INTERVENTION

Children in this group will not receive any musical entertainment; instead, mobilization will be carried out in accordance with the clinic's existing routine procedures, with parental support.

Interventions

musicOTHER

Children in this group will be introduced to music of their choice and preference immediately before the mobilization begins.

music

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between 4-6 years old
  • 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
  • Being a volunteer to participate in the study

You may not qualify if:

  • Having undergone previous surgery
  • Having a chronic illness
  • A parent having undergone abdominal surgery
  • The child having visual, hearing, physical, or intellectual disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Tarsus, Turkey (Türkiye)

Location

Related Publications (7)

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

    BACKGROUND

  • Cote, C. J., & Wilson, S. (2016). Guidelinesformonitoringandmanagement of pediatricpatientsbefore, during, andaftersedationfordiagnosticandtherapeuticprocedures: update 2016. PediatricDentistry, 38(4), E19-E39.

    BACKGROUND

  • Gerçeker, G. Ö., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk anksiyete skalası-durumluluk ve çocuk korku ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13

    BACKGROUND

  • Jones RA, Merkle S, Ruvalcaba L, Ashton P, Bailey C, Lopez M. Nurse-Led Mobility Program: Driving a Culture of Early Mobilization in Medical-Surgical Nursing. J Nurs Care Qual. 2020 Jan/Mar;35(1):20-26. doi: 10.1097/NCQ.0000000000000404.

    PMID: 30889084BACKGROUND

  • Gıynaş, T., Önel, A. E., Küçük, S., Uğur, S., & Yardımcı, F. An Investigation of Using Non-PharmacologicalMethods in Pain Management in PostoperativePeriod in Children: A SystematicReview. Bilecik Şeyh Edebali Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 2(3), 172-190.

    BACKGROUND

  • Sayar, S., & Ergin, D. (2019). Ortopedi servisinde yatan çocuk hastalarda ameliyat sonrası ağrı yönetiminde müziğin etkisinin incelenmesi. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 12(1), 67-73.

    BACKGROUND

  • Kwekkeboom KL, Gretarsdottir E. Systematic review of relaxation interventions for pain. J Nurs Scholarsh. 2006;38(3):269-77. doi: 10.1111/j.1547-5069.2006.00113.x.

    PMID: 17044345BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

January 6, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)