The Effects of Listening to Fairy Tales, Listening to Fairy Tales in Their Mothers' Voices, and Watching Cartoons on Pain, Comfort Levels, and Physiological Parameters During Tracheostomy Care in a Palliative Care Clinic
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- FLACC Pain Scale
研究概览
简要总结
This study aimed to determine the effects of listening to fairy tales, listening to fairy tales from the mother's voice, and watching cartoons on pain, comfort, and physiological parameters during tracheostomy care of children receiving palliative care.
详细描述
Seventeen volunteer children between the ages of 1 and 7 receiving palliative care will be randomly assigned to three groups: a storytelling group, a mother's voice storytelling group, and a cartoon group. Each intervention will be administered once a day for one week. There will be a one-week washout period between interventions, during which time the children will receive routine nursing care. No intervention other than the storytelling or cartoon intervention will be administered to all three groups. Children will be assessed before, during, and after the procedure. PAIN RELATED TO THE TRACEOSTOMY PROCEDURE will be assessed using the FLACC Pain Scale, and comfort will be assessed using the Child Comfort Scale. Additionally, the children's heart rate, respiration, blood pressure, tidal volume, and temperature will be measured using a bedside monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being in the 1-7 year old age group,
- •Being inpatient in a pediatric palliative care unit,
- •Having no visual or hearing abnormalities,
- •Having a tracheostomy.
排除标准
- •The family's desire to withdraw from the study,
- •The child's health condition deteriorates.
研究组 & 干预措施
Control Group
Routine tracheostomy care will be applied to the control group. No action will be taken.
Experimental Group
During the tracheostomy care process, the experimental group will listen to fairy tales and watch cartoons.
干预措施: fairy tales (Other)
Experimental Group
During the tracheostomy care process, the experimental group will listen to fairy tales and watch cartoons.
干预措施: mother's voice (Other)
Experimental Group
During the tracheostomy care process, the experimental group will listen to fairy tales and watch cartoons.
干预措施: Cartoons (Other)
结局指标
主要结局
FLACC Pain Scale
时间窗: baseline and up to 1 weeks
FLACC has reliability and validity to determine observational pain of children aged between 3 and 18 years during the medical procedures. This scale is preferred due to its implicity of application among children. It has five categories of behavior to rate pain, namely, facial expression, leg movement, activity, cry, and consolability. The scores of each category are between 0 and 2. The total scores can range from 0 to 10, defined as mild (1-3), moderate (4-6), and severe (7-10). The higher the score, the greater the pain.
Comfort Scale
时间窗: baseline and up to 1 weeks
It is a sedation and comfort scoring system that includes two physiological and six emotional stress criteria. While it assesses sedation patterns in ventilated children, the parameters assessed can also be considered indicators of pain. The patient child is assessed on six behavioral parameters (alertness, calmness-agitation, respiratory response, physical movement, muscle tone, and facial tension) and two physical parameters (blood pressure and heart rate) within two minutes. Each criterion is scored on a Likert-type scale from one to five. The assessment result is: 27-40 indicates light sedation, 17-26 indicates moderate sedation, and 8-16 indicates deep sedation. The comfort scale assesses the child's level of sedation and also influences pain and comfort levels.
次要结局
- Patient Identification Form(Baseline Characteristics)
- Physiological Parameter Record Form(Baseline and up to 1 week)
研究者
Fatma Güdücü Tüfekci
Prof. Dr.
Ataturk University