The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters During Chest Tube Removal in Infants Undergoing Congenital Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pain level assessed by FLACC Scale
研究概览
简要总结
Chest tube removal in infants undergoing surgery for congenital heart disease is an invasive procedure associated with significant pain and physiological stress responses. This randomized controlled trial evaluates the effects of music and musical mobile interventions on pain and physiological parameters during chest tube removal. A total of 54 infants aged 2-12 months are randomly assigned to music, musical mobile, or control groups. Pain is assessed using the FLACC scale, and physiological parameters (heart rate and oxygen saturation [SpO₂]) are monitored. Measurements are obtained at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). The findings aim to support evidence-based non-pharmacological pain management in pediatric intensive care settings.
详细描述
Chest tube removal is a common but painful procedure in infants undergoing surgery for congenital heart disease and may trigger significant physiological stress responses. Although pharmacological interventions are commonly used, concerns about potential side effects highlight the importance of non-pharmacological approaches.
This study is a randomized controlled trial designed to evaluate the effects of music and musical mobile interventions on procedural pain and physiological parameters. The study is conducted in the Pediatric Cardiovascular Surgery Intensive Care Unit of Başkent University Ankara Hospital. The sample consists of 54 infants aged 2-12 months who meet the eligibility criteria.
Participants are randomly allocated to three groups (music, musical mobile, and control) using block randomization. In the music group, auditory stimulation consisting of ocean and nature sounds is initiated 10 minutes before chest tube removal, continued during the procedure, and maintained for 5 minutes after the procedure. In the musical mobile group, a multisensory intervention combining auditory and visual stimuli is applied during the same time interval. The control group receives standard care routinely provided in the unit.
Pain is assessed using the FLACC Scale. Physiological parameters, including heart rate and oxygen saturation (SpO₂), are monitored using bedside monitors. Outcomes are recorded at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). Crying duration is recorded continuously during the chest tube removal procedure.
Statistical analyses are performed using SPSS software. Depending on data distribution, appropriate parametric or non-parametric tests are applied. This study aims to provide evidence on the effectiveness of multisensory distraction interventions in reducing procedural pain and improving physiological stability in infants undergoing chest tube removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 2 to 12 months
- •Undergoing surgery due to congenital heart disease
- •Having a single chest tube
- •Not receiving mechanical ventilation support
- •Parent(s) voluntarily agree to participate in the study
排除标准
- •Receiving mechanical ventilation support
- •Administration of analgesics within 2 hours prior to chest tube removal
- •Presence of a neurodevelopmental disorder
- •Parent(s) do not consent to participate in the study
研究组 & 干预措施
Music Group
Soft, slow-tempo instrumental music
干预措施: Music Group (Behavioral)
Musical Mobile Group
soft, slow-tempo instrumental music with visual movement
干预措施: Musical Mobile Group (Behavioral)
Control Group
standart care
结局指标
主要结局
Pain level assessed by FLACC Scale
时间窗: 10 minutes before, immediately after, and 5 minutes after chest tube removal
Pain will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
次要结局
- Heart rate(10 minutes before, immediately after, and 5 minutes after chest tube removal)
- Oxygen saturation (SpO₂)(10 minutes before, immediately after, and 5 minutes after chest tube removal)
- Crying Duration(During chest tube removal)