Effectiveness of Music During Cardiac Catheterization

Angiography Clinical Trial

Official title:

Effectiveness of Music During Cardiac Catheterization On Children's Pain, Fear, Anxiety and Vital Signs: A Randomized, Double-Blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316754
• Other study ID #: 2019/369
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: December 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 1, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Angiography

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Dr. Behcet Uz Children's Hospital	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	child's heart rate	the child's pulse rate will be measured.	baseline (at the beginning of angiography)
Primary	child's heart rate	the child's pulse rate will be measured.	1st minute of the angiography
Primary	child's heart rate	the child's pulse rate will be measured.	5th minute of the angiography
Primary	child's heart rate	the child's pulse rate will be measured.	10th minute of the angiography
Primary	child's heart rate	the child's pulse rate will be measured.	30th minute of the angiography
Primary	child's heart rate	the child's pulse rate will be measured.	60th minute of the angiography
Primary	child's respiratory rate	the child's respiratory rate will be measured.	Baseline (at the beginning of angiography)
Primary	child's respiratory rate	the child's respiratory rate will be measured.	1st minute of the angiography
Primary	child's respiratory rate	the child's respiratory rate will be measured.	5th minute of the angiography
Primary	child's respiratory rate	the child's respiratory rate will be measured.	10th minute of the angiography
Primary	child's respiratory rate	the child's respiratory rate will be measured.	15th minute of the angiography
Primary	child's respiratory rate	the child's respiratory rate will be measured.	30th minute of the angiography
Primary	child's respiratory rate	the child's respiratory rate will be measured.	60th minute of the angiography
Primary	child's blood pressure	the child's blood pressure will be measured.	baseline (at the beginning of angiography)
Primary	child's blood pressure	the child's blood pressure will be measured.	1st minute of the angiography
Primary	child's blood pressure	the child's blood pressure will be measured.	5th minute of the angiography
Primary	child's blood pressure	the child's blood pressure will be measured.	10th minute of the angiography
Primary	child's blood pressure	the child's blood pressure will be measured.	15th minute of the angiography
Primary	child's blood pressure	the child's blood pressure will be measured.	30th minute of the angiography
Primary	child's blood pressure	the child's blood pressure will be measured.	60th minute of the angiography
Primary	child's body temperature	the child's body temperature will be measured.	Baseline (at the beginning of angiography)
Primary	child's body temperature	the child's body temperature will be measured.	1st minute of the angiography
Primary	child's body temperature	the child's body temperature will be measured.	5th minute of the angiography
Primary	child's body temperature	the child's body temperature will be measured.	10th minute of the angiography
Primary	child's body temperature	the child's body temperature will be measured.	15th minute of the angiography
Primary	child's body temperature	the child's body temperature will be measured.	30th minute of the angiography
Primary	child's body temperature	the child's body temperature will be measured.	60th minute of the angiography
Primary	child's oxygen saturation	the child's oxygen saturation will be measured.	baseline (at the beginning of angiography)
Primary	child's oxygen saturation	the child's oxygen saturation will be measured.	1st minute of the angiography
Primary	child's oxygen saturation	the child's oxygen saturation will be measured.	5th minute of the angiography
Primary	child's oxygen saturation	the child's oxygen saturation will be measured.	10th minute of the angiography
Primary	child's oxygen saturation	the child's oxygen saturation will be measured.	15th minute of the angiography
Primary	child's oxygen saturation	the child's oxygen saturation will be measured.	30th minute of the angiography
Primary	child's oxygen saturation	the child's oxygen saturation will be measured.	60th minute of the angiography
Primary	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)
Primary	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)
Primary	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)