The Effect of Listening to Music During Mobilization on Pain and Fear in Children Undergoing Abdominal Surgery

NCT ID: NCT07342751

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-06

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This randomized controlled experimental study aims to investigate the impact of music intervention on the pain and fear levels of children during the postoperative mobilization. Mobilization is a critical part of recovery, but it is often delayed in pediatric patients due to factors such as age, anxiety, fear, and pain. The study is designed to provide evidence for nurses on the use of non-pharmacological methods to facilitate early mobilization and improve the quality of surgical care.The research will be conducted at the Aksaray Training and Research Hospital Pediatric Surgery Department between January 2026 and November 2026. The study population consists of 74 children aged 4-6 who have undergone abdominal surgery. Participants will be randomly and equally divided into two groups: a study group (n=37) and a control group (n=37) using a computer-generated randomization program. Inclusion criteria require that the children be undergoing their first postoperative mobilization, have received only a single dose of paracetamol, and have no chronic illnesses or sensory impairments.The methodology involves assessing both groups before and after the mobilization process. Prior to mobilization, the baseline vital signs (heart rate, respiration, etc.) and pain and fear levels of all children will be evaluated by the child, their parents, and a nurse. During the mobilization, the study group will listen to music of their own choice through headphones, while the control group will receive standard clinical care with parental support. Immediately after the child returns to bed, the evaluations and vital sign recordings will be repeated to measure the intervention's effect.To ensure rigorous data collection, the researchers will use the Wong-Baker FACES Pain Rating Scale, the Children's Fear Scale (CFS), and a Vital Signs Tracking Form. Statistical analysis will be performed using SPSS 25.0, utilizing tests such as independent t-tests, Mann-Whitney U, and Chi-square to determine the significance of the results (p \< .05). The study anticipates that the music intervention will significantly lower pain and fear scores, supporting the hypothesis that music is an effective supportive tool in pediatric surgical nursing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Surgery Children, Only

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

music

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.

Group Type EXPERIMENTAL

music

Intervention Type OTHER

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

control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

music

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tarsus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Atiye Karakul

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tarsus University

Tarsus, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

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

Reference Type 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

Reference Type 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.

Reference Type BACKGROUND
PMID: 30889084 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 17044345 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22102025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.