Effectiveness of Music During Cardiac Catheterization
1 other identifier
interventional
33
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
1 active site
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
First Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedStudy Start
First participant enrolled
March 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedDecember 30, 2021
December 1, 2021
1.1 years
March 9, 2020
December 10, 2021
Conditions
Outcome Measures
Primary Outcomes (37)
child's heart rate
the child's pulse rate will be measured.
baseline (at the beginning of angiography)
child's heart rate
the child's pulse rate will be measured.
1st minute of the angiography
child's heart rate
the child's pulse rate will be measured.
5th minute of the angiography
child's heart rate
the child's pulse rate will be measured.
10th minute of the angiography
child's heart rate
the child's pulse rate will be measured.
30th minute of the angiography
child's heart rate
the child's pulse rate will be measured.
60th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
Baseline (at the beginning of angiography)
child's respiratory rate
the child's respiratory rate will be measured.
1st minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
5th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
10th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
15th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
30th minute of the angiography
child's respiratory rate
the child's respiratory rate will be measured.
60th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
baseline (at the beginning of angiography)
child's blood pressure
the child's blood pressure will be measured.
1st minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
5th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
10th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
15th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
30th minute of the angiography
child's blood pressure
the child's blood pressure will be measured.
60th minute of the angiography
child's body temperature
the child's body temperature will be measured.
Baseline (at the beginning of angiography)
child's body temperature
the child's body temperature will be measured.
1st minute of the angiography
child's body temperature
the child's body temperature will be measured.
5th minute of the angiography
child's body temperature
the child's body temperature will be measured.
10th minute of the angiography
child's body temperature
the child's body temperature will be measured.
15th minute of the angiography
child's body temperature
the child's body temperature will be measured.
30th minute of the angiography
child's body temperature
the child's body temperature will be measured.
60th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
baseline (at the beginning of angiography)
child's oxygen saturation
the child's oxygen saturation will be measured.
1st minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
5th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
10th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
15th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
30th minute of the angiography
child's oxygen saturation
the child's oxygen saturation will be measured.
60th minute of the angiography
child's fear
Child fear will be assessed by "Children's Fear Scale". This scale includes 5 different facial expressions. This scale is rated from 0-4 and it is stated that it is a reliable and valid measurement tool for the assessment of fear.
up to 60 min (when the child wakes up from anaesthetic)
child's anxiety
Child anxiety will be assessed by the "State Anxiety Scale". This scale includes 5 different facial expressions. The children are expected to evaluate how they feel at the moment. Expressions such as "I feel very angry", "I feel angry or" I do not feel angry "are asked to mark the most appropriate one for them. The total number of items is 20. The lowest score is 20, the highest the score is 60.
up to 60 min (when the child wakes up from anaesthetic)
child's pain
Child pain will be assessed by the " Numeric Pain Scale". This method is intended to determine the severity of pain and to explain the patient's pain in numbers. On numerical scales, it starts with the absence of pain (0) and reaches the level of unbearable pain (10).
up to 60 min (when the child wakes up from anaesthetic)
Study Arms (3)
Control group
NO INTERVENTIONNo music will be played to the control group.
Intervention 1
ACTIVE COMPARATORDuring angiography, the Intervention-1 group will listen to the music that the child wants to listen.
Intervention-2
ACTIVE COMPARATORThe 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)
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- Intubation of the child during angiography
- Parent's refusal to take part in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Izmir Katip Celebi Universitylead
- Dr. Behcet Uz Children's Hospitalcollaborator
Study Sites (1)
Dr. Behcet Uz Children's Hospital
Izmir, 35640, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 35279331DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Timur MEŞE, prof.
Ministry of Health- İzmir Turkey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant, Faculty of Health Sciences, Department of Pediatric Nursing
Study Record Dates
First Submitted
March 9, 2020
First Posted
March 20, 2020
Study Start
March 20, 2020
Primary Completion
April 15, 2021
Study Completion
August 1, 2021
Last Updated
December 30, 2021
Record last verified: 2021-12