Effectiveness of Music During Cardiac Catheterization

Izmir Katip Celebi University

Status: Completed

Conditions: Angiography

Treatments: Other: music

Study type: Interventional

Funder types: Other

Identifiers

NCT04316754

2019/369

Details and patient eligibility

About

The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.

Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.

During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.

"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.

Full description

This study was planned to determine the effect of music during angiography on pain, fear, anxiety and life signs in children aged 7-18.

The research was planned on a randomized controlled experimental basis. Simple stratified randomization will be performed according to gender and age. Consent will be obtained from children and parents who agree to participate in the research.

Before angiography, "Child Fear Scale", "State-Trait Anxiety Scale (STAI-TX)", and "Vital Signs Follow-up Form" will be applied to all children taking part in the study and life signs will be recorded.

The sample size of the study was determined and the effect size was 0.25 based on the Standard effect sizes determined by Cohen. In the study, the sample number of 0.84 in the statistical power α=0.05 confidence interval was calculated as 36 for each group.

During angiography, the first group will listen to the music that the child wants to listen to. The second group will listen to the music which determined by the researchers. No music will be played to the control group. During angiography (when the child is listening to the music) vital signs will be recorded in 0. min., 1st minute, 5th minute, 10th minute, 15th minute, 30th minute and 60th minute.

"Numerical Pain Scale", "Child Fear Scale", "State Anxiety Scale", and "Vital Signs Follow-up Form" will be re-evaluated to all three groups after angiography.

Enrollment: 33 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Volunteering to participate in research
• Being between 7-18 years of age
• Lack of communication problems (vision, hearing, mental)
• Being informed about surgical intervention
• Lack of prior surgical intervention experience
• Receiving sedoanalgesia during angiography

Exclusion criteria

• Intubation of the child during angiography
• Parent's refusal to take part in the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 3 patient groups

Control group

No Intervention group

Description:

No music will be played to the control group.

Intervention 1

Active Comparator group

Description:

During angiography, the Intervention-1 group will listen to the music that the child wants to listen.

Treatment:

Other: music

Intervention-2

Active Comparator group

Description:

The Intervention-2 group will listen to the music which determined by the researchers. The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach. The music to be played has been decided by examining the literature. (DOI: 10.4274/jpr.24892)

Treatment:

Other: music