Effectiveness of Music During Cardiac Catheterization On Children's Pain, Fear, Anxiety and Vital Signs: A Randomized, Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- child's body temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Intubation of the child during angiography
- •Parent's refusal to take part in the study
研究组 & 干预措施
Control group
No music will be played to the control group.
Intervention 1
During angiography, the Intervention-1 group will listen to the music that the child wants to listen.
干预措施: music (Other)
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)
干预措施: music (Other)
结局指标
主要结局
child's body temperature
时间窗: 60th minute of the angiography
the child's body temperature will be measured.
child's heart rate
时间窗: 60th minute of the angiography
the child's pulse rate will be measured.
child's oxygen saturation
时间窗: 60th minute of the angiography
the child's oxygen saturation will be measured.
child's respiratory rate
时间窗: 60th minute of the angiography
the child's respiratory rate will be measured.
child's blood pressure
时间窗: 60th minute of the angiography
the child's blood pressure will be measured.
child's fear
时间窗: 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.
child's anxiety
时间窗: 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.
child's pain
时间窗: 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).
child's heart rate
时间窗: baseline (at the beginning of angiography)
the child's pulse rate will be measured.
child's heart rate
时间窗: 1st minute of the angiography
the child's pulse rate will be measured.
child's heart rate
时间窗: 5th minute of the angiography
the child's pulse rate will be measured.
child's heart rate
时间窗: 10th minute of the angiography
the child's pulse rate will be measured.
child's heart rate
时间窗: 30th minute of the angiography
the child's pulse rate will be measured.
child's respiratory rate
时间窗: Baseline (at the beginning of angiography)
the child's respiratory rate will be measured.
child's respiratory rate
时间窗: 1st minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
时间窗: 5th minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
时间窗: 10th minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
时间窗: 15th minute of the angiography
the child's respiratory rate will be measured.
child's respiratory rate
时间窗: 30th minute of the angiography
the child's respiratory rate will be measured.
child's blood pressure
时间窗: baseline (at the beginning of angiography)
the child's blood pressure will be measured.
child's blood pressure
时间窗: 1st minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
时间窗: 5th minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
时间窗: 10th minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
时间窗: 15th minute of the angiography
the child's blood pressure will be measured.
child's blood pressure
时间窗: 30th minute of the angiography
the child's blood pressure will be measured.
child's body temperature
时间窗: Baseline (at the beginning of angiography)
the child's body temperature will be measured.
child's body temperature
时间窗: 1st minute of the angiography
the child's body temperature will be measured.
child's body temperature
时间窗: 5th minute of the angiography
the child's body temperature will be measured.
child's body temperature
时间窗: 10th minute of the angiography
the child's body temperature will be measured.
child's body temperature
时间窗: 15th minute of the angiography
the child's body temperature will be measured.
child's body temperature
时间窗: 30th minute of the angiography
the child's body temperature will be measured.
child's oxygen saturation
时间窗: baseline (at the beginning of angiography)
the child's oxygen saturation will be measured.
child's oxygen saturation
时间窗: 1st minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
时间窗: 5th minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
时间窗: 10th minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
时间窗: 15th minute of the angiography
the child's oxygen saturation will be measured.
child's oxygen saturation
时间窗: 30th minute of the angiography
the child's oxygen saturation will be measured.
次要结局
未报告次要终点
研究者
ESRA ARDAHAN AKGUL
Research Assistant, Faculty of Health Sciences, Department of Pediatric Nursing
Izmir Katip Celebi University