The Effect of Maternal Voice Played to Children on Mechanical Ventilators on Pain, Sedation, and Physiological Parameters: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- COMFORT Scale Score
研究概览
简要总结
Children in the pediatric intensive care unit often experience pain and stress from medical procedures, even while sedated. This study will test whether playing a recording of the child's mother's voice helps reduce pain and the need for sedation medication in children aged 1 to 3 years who are on a breathing machine (mechanical ventilator). Children will be randomly placed into one of two groups: one group will listen to a 10-minute recording of their mother's voice through headphones, while the other group will receive usual care with no recording. Researchers will measure pain and comfort levels, heart rate, oxygen levels, blood pressure, and breathing rate before, during, and after the session to see if listening to the mother's voice makes a difference.
详细描述
This randomized controlled trial will be conducted in the Pediatric Intensive Care Unit (PICU) of Kayseri City Hospital. Eligible children (aged 1-3 years, intubated, mechanically ventilated, and sedated, with no change in sedation dose in the prior 24 hours) will be assigned to an intervention or control group using stratified block randomization (stratified by age, sex, diagnosis duration, and COMFORT scale score), with simple randomization within blocks performed by an independent researcher.
In the intervention group, each child's mother will be asked to read a children's storybook aloud in a quiet room, and this reading will be recorded (approximately 10 minutes). The recording will then be played to the child once, through wireless over-ear headphones at a safe volume (50-55 dB), during a single morning session. The COMFORT Scale and physiological parameters (heart rate, oxygen saturation, blood pressure, respiratory rate) will be assessed before, during, and after the recording is played. All sessions will be video recorded so that COMFORT Scale scores can also be scored by independent, blinded observers.
Children in the control group will receive standard unit care with no additional intervention, and will be assessed on the same schedule and with the same tools as the intervention group.
Data will be analyzed using IBM SPSS 27.0. Group comparisons will use Chi-square, Independent/Paired Samples t-tests, or Mann-Whitney U/Wilcoxon tests as appropriate, with statistical significance set at p < 0.05.
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
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1-3 years, intubated and mechanically ventilated under sedation
- •No change in sedation dose within the last 24 hours
- •No hearing impairment in the child
- •Parent has no visual, hearing, or speech impairment
- •Parent is a Turkish speaker/reader with at least a primary school education
- •Parent provides written and verbal informed consent
排除标准
- •Children receiving care/treatment due to surgical operation or trauma
- •Children who experience cardiac arrest during the study
- •Children whose parent withdraws consent during the study
- •Children who are extubated during the study
研究组 & 干预措施
Maternal Voice Intervention Group
Children received a single ~10-minute recording of their mother's voice reading a children's storybook, played once through wireless over-ear headphones at 50-55 dB during a single morning session, with no other interventions during playback.
干预措施: Recorded Maternal Voice (Behavioral)
Control Group
Children received standard PICU care with no additional intervention. Assessments (COMFORT Scale, physiological parameters, video recording) were performed on the same schedule as the intervention group.
结局指标
主要结局
COMFORT Scale Score
时间窗: Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment
The COMFORT Scale assesses pain and sedation level in critically ill children based on alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension. Scores will be compared between the maternal voice intervention group and the control group.
COMFORT Scale
时间窗: Assessed before (~5 min), during (~10 min), and immediately after (~5 min) the intervention, within a single ~20-minute session on the day of enrollment
The COMFORT Scale (full behavioral and physiological scale for assessing pain and sedation level in critically ill children) assesses eight items - alertness, calmness, respiratory response, physical movement, blood pressure, heart rate, muscle tone, and facial tension - each scored 1 to 5, yielding a total score ranging from 8 (minimum) to 40 (maximum). Higher scores indicate greater distress/pain and inadequate sedation, while lower scores indicate deeper sedation and better comfort. Scores will be compared between the maternal voice intervention group and the control group.
次要结局
未报告次要终点
研究者
Gamze Nur Güzel
nurse
TC Erciyes University