Letting Children Listen to Music During Computed Tomography

Fear Clinical Trial

Official title:

Effect of Music on Fear and Anxiety in Children During Tomography: Randomized Controlled Double-Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06086509
• Other study ID #: A/BU-HEM-ZDI-01
• Status: Completed
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: October 2023
• Source: Gümüshane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Computed Tomography
• Fear

Intervention

Other:
• Music
Children were played music during computerized tomography.

Locations

Country	Name	City	State
Turkey	Gümüshane University	Gümüshane

Sponsors (1)

Lead Sponsor	Collaborator
Gümüshane University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Child Anxiety Scale-State (CAS-S)	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	one month