Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2020-03-20
2021-08-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control group
No music will be played to the control group.
No interventions assigned to this group
Intervention 1
During angiography, the Intervention-1 group will listen to the music that the child wants to listen.
music
During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the "Arts of Fugue" by Bach. No music will be played to the control group.
Intervention-2
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)
music
During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the "Arts of Fugue" by Bach. No music will be played to the control group.
Interventions
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music
During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the "Arts of Fugue" by Bach. No music will be played to the control group.
Eligibility Criteria
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Inclusion Criteria
* 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
* Parent's refusal to take part in the study
7 Years
18 Years
ALL
No
Sponsors
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Dr. Behcet Uz Children's Hospital
OTHER
Izmir Katip Celebi University
OTHER
Responsible Party
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ESRA ARDAHAN AKGUL
Research Assistant, Faculty of Health Sciences, Department of Pediatric Nursing
Principal Investigators
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Timur MEŞE, prof.
Role: STUDY_DIRECTOR
Ministry of Health- İzmir Turkey
Locations
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Dr. Behcet Uz Children's Hospital
Izmir, , Turkey (Türkiye)
Countries
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References
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Karakul A, Akgul EA, Yaliniz R, Mese T. Effectiveness of music during cardiac catheterization on children's pain, fear, anxiety and vital signs: A randomized, blind controlled trial. J Pediatr Nurs. 2022 Jul-Aug;65:e56-e62. doi: 10.1016/j.pedn.2022.02.009. Epub 2022 Mar 10.
Other Identifiers
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2019/369
Identifier Type: -
Identifier Source: org_study_id