- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342751
The Effect of Listening to Music During Mobilization on Pain and Fear in Children Undergoing Abdominal Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tarsus, Turkey (Türkiye)
- Tarsus University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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Children in this group will be introduced to music of their choice and preference immediately before the mobilization begins.
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Wong-Baker Scale
Time Frame: 1 day
|
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.
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1 day
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Fear Scale
Time Frame: 1 day
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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.
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1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Christiaens, G. (2003). Independent nursing interventions for pain management. Home health care management &practice, 15(3), 212-214.
- Cote, C. J., & Wilson, S. (2016). Guidelinesformonitoringandmanagement of pediatricpatientsbefore, during, andaftersedationfordiagnosticandtherapeuticprocedures: update 2016. PediatricDentistry, 38(4), E19-E39.
- 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
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22102025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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