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Completed

NCT Number: NCT04316754

Effectiveness of Music During Cardiac Catheterization

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.

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Key information

Conditions

Angiography

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Behcet Uz Children's Hospital

Izmir, 35640, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

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.

Primary outcomes

  1. child's heart rate

    Time frame: baseline (at the beginning of angiography)

    the child's pulse rate will be measured.

  2. child's heart rate

    Time frame: 1st minute of the angiography

    the child's pulse rate will be measured.

  3. child's heart rate

    Time frame: 5th minute of the angiography

    the child's pulse rate will be measured.

  4. child's heart rate

    Time frame: 10th minute of the angiography

    the child's pulse rate will be measured.

  5. child's heart rate

    Time frame: 30th minute of the angiography

    the child's pulse rate will be measured.

  6. child's heart rate

    Time frame: 60th minute of the angiography

    the child's pulse rate will be measured.

  7. child's respiratory rate

    Time frame: Baseline (at the beginning of angiography)

    the child's respiratory rate will be measured.

  8. child's respiratory rate

    Time frame: 1st minute of the angiography

    the child's respiratory rate will be measured.

  9. child's respiratory rate

    Time frame: 5th minute of the angiography

    the child's respiratory rate will be measured.

  10. child's respiratory rate

    Time frame: 10th minute of the angiography

    the child's respiratory rate will be measured.

  11. child's respiratory rate

    Time frame: 15th minute of the angiography

    the child's respiratory rate will be measured.

  12. child's respiratory rate

    Time frame: 30th minute of the angiography

    the child's respiratory rate will be measured.

  13. child's respiratory rate

    Time frame: 60th minute of the angiography

    the child's respiratory rate will be measured.

  14. child's blood pressure

    Time frame: baseline (at the beginning of angiography)

    the child's blood pressure will be measured.

  15. child's blood pressure

    Time frame: 1st minute of the angiography

    the child's blood pressure will be measured.

  16. child's blood pressure

    Time frame: 5th minute of the angiography

    the child's blood pressure will be measured.

  17. child's blood pressure

    Time frame: 10th minute of the angiography

    the child's blood pressure will be measured.

  18. child's blood pressure

    Time frame: 15th minute of the angiography

    the child's blood pressure will be measured.

  19. child's blood pressure

    Time frame: 30th minute of the angiography

    the child's blood pressure will be measured.

  20. child's blood pressure

    Time frame: 60th minute of the angiography

    the child's blood pressure will be measured.

  21. child's body temperature

    Time frame: Baseline (at the beginning of angiography)

    the child's body temperature will be measured.

  22. child's body temperature

    Time frame: 1st minute of the angiography

    the child's body temperature will be measured.

  23. child's body temperature

    Time frame: 5th minute of the angiography

    the child's body temperature will be measured.

  24. child's body temperature

    Time frame: 10th minute of the angiography

    the child's body temperature will be measured.

  25. child's body temperature

    Time frame: 15th minute of the angiography

    the child's body temperature will be measured.

  26. child's body temperature

    Time frame: 30th minute of the angiography

    the child's body temperature will be measured.

  27. child's body temperature

    Time frame: 60th minute of the angiography

    the child's body temperature will be measured.

  28. child's oxygen saturation

    Time frame: baseline (at the beginning of angiography)

    the child's oxygen saturation will be measured.

  29. child's oxygen saturation

    Time frame: 1st minute of the angiography

    the child's oxygen saturation will be measured.

  30. child's oxygen saturation

    Time frame: 5th minute of the angiography

    the child's oxygen saturation will be measured.

  31. child's oxygen saturation

    Time frame: 10th minute of the angiography

    the child's oxygen saturation will be measured.

  32. child's oxygen saturation

    Time frame: 15th minute of the angiography

    the child's oxygen saturation will be measured.

  33. child's oxygen saturation

    Time frame: 30th minute of the angiography

    the child's oxygen saturation will be measured.

  34. child's oxygen saturation

    Time frame: 60th minute of the angiography

    the child's oxygen saturation will be measured.

  35. child's fear

    Time frame: up to 60 min (when the child wakes up from anaesthetic)

    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.

  36. child's anxiety

    Time frame: up to 60 min (when the child wakes up from anaesthetic)

    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.

  37. child's pain

    Time frame: up to 60 min (when the child wakes up from anaesthetic)

    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).

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Collaborators

  • Dr. Behcet Uz Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2020
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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