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Letting Children Listen to Music During Computed Tomography

Sponsor
Gümüşhane Universıty (Other)
Overall Status
Completed
CT.gov ID
NCT06086509
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
5.1
Actual Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Music
 N/A

Detailed Description

Aim: This research was conducted to determine the effect of music played during computerized tomography (CT) imaging in children on fear, anxiety and vital signs.

Method: This randomized, double-blind controlled trial was conducted with Consolidated Standards of Reporting Studies (CONSORT) guidelines. The sample includes children aged 5-10 years who had CT scans in the emergency department of a public hospital in eastern Turkey between April 18 and May 20, 2023 and met the inclusion criteria for the study. The research was completed with a total of 60 children, divided evenly into one of two groups. The nursing intervention of the research is to listen to music. Data were collected through face-to-face interviews using the Child and Family Information Form, the Child Fear Scale, the State Anxiety Scale for Children, and the Vital Signs Monitoring Form (pulse, blood pressure, and oxygen saturation). Ethical principles were followed in the research.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
They were divided into two groups: control group and experimental group.They were divided into two groups: control group and experimental group.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Effect of Music on Fear and Anxiety in Children During Tomography: Randomized Controlled Double-Blind Study
Actual Study Start Date :
Apr 18, 2023
Actual Primary Completion Date :
May 20, 2023
Actual Study Completion Date :
Sep 20, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

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.
Experimental: music group

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
Children were played music during computerized tomography.

Outcome Measures

Primary Outcome Measures

  1. Children's Fear Scale (CFS) [one month]

    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).

Secondary Outcome Measures

  1. Child Anxiety Scale-State (CAS-S) [one month]

    The Child Anxiety Scale-State Scale resembles a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, instructs children to "Imagine that all your anxious or nervous feelings are in the bulb or bottom part of the thermometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Being between the ages of 5-10

  • Hospitalization is for diagnostic or treatment purposes

  • The child and the parent speak and understand Turkish comfortably.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gümüşhane University Gümüşhane Turkey

Sponsors and Collaborators

  • Gümüşhane Universıty

Investigators

  • Principal Investigator: Fatma KURUDİREK, Atatürk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeynep Demir, lecturer, Gümüşhane Universıty
ClinicalTrials.gov Identifier:
NCT06086509
Other Study ID Numbers:
  • A/BU-HEM-ZDİ-01
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeynep Demir, lecturer, Gümüşhane Universıty
Child
Music
Anxiety
Fear

Study Results

No Results Posted as of Oct 17, 2023