Effect of Live Environmental Music Therapy and Pre-recorded Music on State-Anxiety, Stress, Pain, and Wellbeing Levels of Patients and Caregivers in the Emergency Unit Waiting Area: A Multi-Center Randomized Clinical Trial Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 243
- 试验地点
- 3
- 主要终点
- State-anxiety
研究概览
简要总结
Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music selection. The aim of this study is to determine the effect of live Environmental Music Therapy (EMT) and pre-recorded music on state-anxiety, stress, pain and well-being levels in patients and caregivers in the emergency unit waiting areas of two hospitals in Colombia.
This study is a multi-center randomized clinical trial, with three arms: standard care + live EMT, standard care + pre-recorded music, and standard care only. The primary outcome measure is the six-item State-Trait Anxiety Inventory (STAI-6). Secondary outcome measures are pain and stress levels, both measured with a Visual Analogue Scales (VAS), and well-being, measured with the Well-Being Numerical Rating Scales (WB-NRSs). The scales will be applied before and after each intervention.
This study seeks to contribute to improving mental health, wellbeing, and quality of care of patients and caregivers in the waiting area of the emergency units. This is the first study in Colombia investigating the effect live music therapy and pre-recorded music interventions in the emergency department.
详细描述
Main objective:
To determine the effect of standard care+ EMT or pre-recorded music on the state-anxiety, stress, pain, and wellbeing levels of anxiety-state, stress, pain, and well-being in adult patients and in the emergency waiting rooms of the Clínica Keralty Ibagué and Clínica Iberoamérica as compared to standard care alone.
Secondary objectives:
- Compare the sociodemographic and clinical characteristics of study participants according to the assigned intervention group.
- Evaluate the effect of EMT and pre-recorded music compared to the control group on state anxiety, stress, and wellbeing levels in adult patients and caregivers/companions in the emergency waiting rooms.
- Evaluate the effect of EMT and pre-recorded music compared to the control group on pain levels in patients in the emergency waiting rooms.
- Determine the variables that modify the effect of the interventions on primary and secondary outcomes in adult patients and their caregivers/companions in the emergency waiting rooms.
Methods Study Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients and caregivers/companions of legal age present in the emergency waiting room present during the intervention and control conditions.
- •Patients whose triage does not represent immediate threat to life or severely ill patients (i.e., triage 3, 4 and 5)
- •Patients and caregivers/companions with literacy skills.
排除标准
- •Patients and caregivers/companions who report having hearing problems
- •Patients and caregivers/companions with difficulties in understanding and/or filling out the questionnaires.
- •Patients and/or caregivers/companions who do not consent to participate in the study.
结局指标
主要结局
State-anxiety
时间窗: The intervention will have a duration of twenty minutes. The STAI-6 will be administered prior to the intervention and immediately following its conclusion.
It will be measured with the Spanish version of the state scale of the six-item State-Trait Anxiety Inventory (STAI-6) scored on a Likert scale from 1 "absence of anxiety" to 4 "high anxiety".
次要结局
- Wellbeing(The intervention will have a duration of twenty minutes. The WB-NRS will be administered prior to the intervention and immediately following its conclusion.)
- Stress(The intervention will have a duration of twenty minutes. The VAS-S will be administered prior to the intervention and immediately following its conclusion.)
- Pain (patients only)(The intervention will have a duration of twenty minutes. The VAS-P will be administered prior to the intervention and immediately following its conclusion.)
研究者
Claudia Aristizábal
Director
Sanitas University