NCT07128758

Brief Summary

This randomized controlled study aimed to evaluate the effect of music listening on the initial mobility level of children who underwent appendectomy. The study was conducted at Ankara Etlik City Hospital, Pediatric Surgery Clinic, between March and May 2025. A total of 68 children aged 6-18 years, with no other systematic diseases and who consented to participate, were included. The music group consisted of 34 children and the control group of 34. A specially designed music pool, tailored separately for 6-11 and 12-18 age groups, was developed through child interviews, expert opinions, national education materials, and evidence-based motivational music. Children in the music group listened to music postoperatively, while the control group received only standard clinical care. Data were collected using the Child Information Form, Patient Mobility Scale, and Observer Mobility Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 30, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

AppendectomyChildInitial MobilityMobilizationMusic Listening

Outcome Measures

Primary Outcomes (2)

  • Patient Mobility Score (Patient Mobility Scale Score)

    Completed by the patient. The six-item scale evaluates three key postoperative mobilization activities: sitting on the bedside, standing at the bedside, and walking in the patient room. Each item is scored between 0 and 15, with the total scale score ranging from 0 to 90. Higher scores indicate greater pain and difficulty during mobilization, while lower scores reflect reduced pain and ease of movement.

    immediately after the surgery

  • The Observer Mobility Score (The Observer Mobility Scale Score)

    Completed by the observer. The Observer Mobility Scale developed by the same authors as a complementary dimension to the Patient Mobility Scale, evaluates objective observations of the same three postoperative activities. Each item is scored on a scale of 1 to 5, with a total score range of 3 to 15. Higher scores reflect poorer mobility performance, while lower scores indicate better and more adequate postoperative mobility.

    immediately after the surgery

Study Arms (2)

Music Group Implementation

EXPERIMENTAL

Before surgery, children were asked whether they enjoyed listening to music and what styles of music they liked. * A 30-minute playlist was created using songs from the music pool based on the child's preferences. * Children were informed about postoperative mobility and which movements they would be expected to perform.

Behavioral: Music Group Implementation Before surgery, children were asked whether they enjoyed listening to music and what styles of music they liked.

Control Group

NO INTERVENTION

No music Listening

Interventions

All procedures required for developing a music pool to be used for music listening intervention in children undergoing appendectomy were completed and are outlined as follows: * Children were asked about their music preferences. * Songs were selected from the Ministry of National Education's music books. * Music with proven effectiveness was selected from music platforms. * A music pool was created by the researcher based on these inputs. * Expert opinions were obtained from 12 academicians and 10 healthy children regarding the music pool. * Necessary revisions were made in line with expert feedback, and the final version of the music pool was determined. * A pilot application was conducted (data from the pilot were not included in the main data set). * Children were randomly assigned to the music and control groups using randomization (https://www.random.org). * A neutral observer (not the researcher/a blinded observer) was trained to administer the scales after the music intervention

Music Group Implementation

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The child must have undergone an appendectomy.
  • Be between the ages of 6 and 18.
  • Have no motor impairments that would impede mobility.
  • Have no additional chronic/systemic diseases.

You may not qualify if:

  • Refusal to continue participating in the study at any stage.
  • Refusal to participate in the first mobility measurement of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Islam T, Sagor MS, Tamanna NT, Bappy MKI, Danishuddin, Haque MA, Lackner M. Exploring the Immunological Role of the Microbial Composition of the Appendix and the Associated Risks of Appendectomies. J Pers Med. 2025 Mar 14;15(3):112. doi: 10.3390/jpm15030112.

    PMID: 40137428BACKGROUND
  • Pratiwi, E. and F.M. Said, The role of paediatric nurse to enhance atraumatic care for hospitalised children: Literature review. Malaysian Journal of Medical Research, 2025. 9(1): p. 42-51.

    BACKGROUND
  • Prastyo, W.A. and A.I. Nugraheni, Management strategies and surgical outcomes for pediatric appendicitis: A literature review. The Indonesian Journal of General Medicine, 2025. 10(2): p. 11-24.

    BACKGROUND
  • Selvaggi L, Pata F, Pellino G, Podda M, Di Saverio S, De Luca GM, Sperlongano P, Selvaggi F, Nardo B. Acute appendicitis and its treatment: a historical overview. Int J Colorectal Dis. 2025 Jan 30;40(1):28. doi: 10.1007/s00384-024-04793-7.

    PMID: 39881071BACKGROUND

Study Officials

  • Fatma Dilek Turan, PhD

    Akdeniz University

    STUDY DIRECTOR
  • Özgür Çağlar, MD

    Ankara Etlik City Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 19, 2025

Study Start

January 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

August 19, 2025

Record last verified: 2025-07

Locations