Clinical trial NCT04316754: Effectiveness of Music During Cardiac Catheterization
Official title: Effectiveness of Music During Cardiac Catheterization On Children's Pain, Fear, Anxiety and Vital Signs: A Randomized, Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angiography
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Dr. Behcet Uz Children's Hospital
First posted: 2020-03-20
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: child's heart rate
timeFrame: baseline (at the beginning of angiography)
measure: child's heart rate
timeFrame: 1st minute of the angiography
measure: child's heart rate
timeFrame: 5th minute of the angiography
measure: child's heart rate
timeFrame: 10th minute of the angiography
measure: child's heart rate
timeFrame: 30th minute of the angiography
measure: child's heart rate
timeFrame: 60th minute of the angiography
measure: child's respiratory rate
timeFrame: Baseline (at the beginning of angiography)
measure: child's respiratory rate
timeFrame: 1st minute of the angiography
measure: child's respiratory rate
timeFrame: 5th minute of the angiography
measure: child's respiratory rate
timeFrame: 10th minute of the angiography
measure: child's respiratory rate
timeFrame: 15th minute of the angiography
measure: child's respiratory rate
timeFrame: 30th minute of the angiography
measure: child's respiratory rate
timeFrame: 60th minute of the angiography
measure: child's blood pressure
timeFrame: baseline (at the beginning of angiography)
measure: child's blood pressure
timeFrame: 1st minute of the angiography
measure: child's blood pressure
timeFrame: 5th minute of the angiography
measure: child's blood pressure
timeFrame: 10th minute of the angiography
measure: child's blood pressure
timeFrame: 15th minute of the angiography
measure: child's blood pressure
timeFrame: 30th minute of the angiography
measure: child's blood pressure
timeFrame: 60th minute of the angiography
measure: child's body temperature
timeFrame: Baseline (at the beginning of angiography)
measure: child's body temperature
timeFrame: 1st minute of the angiography
measure: child's body temperature
timeFrame: 5th minute of the angiography
measure: child's body temperature
timeFrame: 10th minute of the angiography
measure: child's body temperature
timeFrame: 15th minute of the angiography
measure: child's body temperature
timeFrame: 30th minute of the angiography
measure: child's body temperature
timeFrame: 60th minute of the angiography
measure: child's oxygen saturation
timeFrame: baseline (at the beginning of angiography)
measure: child's oxygen saturation
timeFrame: 1st minute of the angiography
measure: child's oxygen saturation
timeFrame: 5th minute of the angiography
measure: child's oxygen saturation
timeFrame: 10th minute of the angiography
measure: child's oxygen saturation
timeFrame: 15th minute of the angiography
measure: child's oxygen saturation
timeFrame: 30th minute of the angiography
measure: child's oxygen saturation
timeFrame: 60th minute of the angiography
measure: child's fear
timeFrame: up to 60 min (when the child wakes up from anaesthetic)
measure: child's anxiety
timeFrame: up to 60 min (when the child wakes up from anaesthetic)
measure: child's pain
timeFrame: up to 60 min (when the child wakes up from anaesthetic)
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr. Behcet Uz Children's Hospital
Study officials:
affiliation: Ministry of Health- İzmir Turkey
name: Timur MEŞE, prof.
role: STUDY_DIRECTOR
References:
citation: 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.