NCT06086509

Brief Summary

This study examines the effect of music during computed tomography in children. This study, conducted on a total of 60 children, was divided into two groups: the music group and the control group. According to the research results; showed that music reduces fear and anxiety levels in children and stabilizes vital signs (pulse and respiratory rate) during a tomography scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

September 30, 2023

Last Update Submit

October 16, 2023

Conditions

FearComputed Tomography

Keywords

ChildMusicAnxietyFear

Outcome Measures

Primary Outcomes (1)

  • Children's Fear Scale (CFS)

    Children's Fear Scale is a scale scored between 0 and 4 showing five faces varying between a neutral expression (0 = no fear) to fearful face (4 = extreme fear).

    one month

Secondary Outcomes (1)

  • Child Anxiety Scale-State (CAS-S)

    one month

Study Arms (2)

control group

NO INTERVENTION

Questionnaires and scales were filled out by the researcher five minutes before the CT scan. Routine CT scans were performed on the control group without listening to music by wearing a Bluetooth headset. The scales were repeated five minutes after the CT scan.

music group

EXPERIMENTAL

Questionnaires and scales were filled out by the researcher five minutes before the CT scan. Just before the CT scan began, the children in the music group were started to listen to "Lullaby K 350" music by inserting a Bluetooth headset into their ears. If the process took longer, the music was played again. Additionally, the Bluetooth headset was properly disinfected before each use to prevent the spread of infectious diseases among patients.

Other: Music

Interventions

MusicOTHER

Children were played music during computerized tomography.

music group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being between the ages of 5-10
  • Hospitalization is for diagnostic or treatment purposes
  • The child and the parent speak and understand Turkish comfortably.

You may not qualify if:

  • Having previous tomography shooting experience
  • Having chronic diseases
  • Visual, auditory, speech and mental disorders
  • There is a history of sedative, analgesic or narcotic substance use within 24 hours before application.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gümüşhane University

Gümüşhane, Turkey (Türkiye)

Location

Related Publications (1)

  • Kurudirek F, Demir Barbak Z, Demir Imamoglu Z, Ciftci K, Delice O. The Effect of Music on Fear and Anxiety of Children During Tomography: A Randomized Controlled Double-Blind Study. Int J Nurs Pract. 2025 Jun;31(3):e70029. doi: 10.1111/ijn.70029.

    PMID: 40511812DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fatma KURUDİREK

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blindness method was used to avoid bias in this study. The researcher, who evaluated the children's anxiety and fear levels during and after the tomography in order to prevent selection bias, did not know which group the children and their families were in.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: They were divided into two groups: control group and experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 30, 2023

First Posted

October 17, 2023

Study Start

April 18, 2023

Primary Completion

May 20, 2023

Study Completion

September 20, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

TU(1)