Comparison of the Effects of Benson Relaxation Technique, Mindfulness-Based Meditation, and Breathing Therapy on Alarm Fatigue and Psychological Well-Being in Intensive Care Nurses: A Four-Arm, Assessor-Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Psychological Well-Being
研究概览
简要总结
The goal of this clinical trial is to compare the effects of the Benson Relaxation Technique, mindfulness-based stress reduction meditation, and breathing therapy on reducing alarm fatigue and improving psychological well-being in intensive care unit (ICU) nurses.
The main questions it aims to answer are:
Do the Benson Relaxation Technique, mindfulness-based stress reduction meditation, and breathing therapy significantly reduce alarm fatigue in ICU nurses?
Do these interventions significantly improve psychological well-being in ICU nurses?
Researchers will compare three intervention groups (Benson Relaxation Technique, mindfulness-based stress reduction meditation, breathing therapy) with a control group receiving no intervention to determine which approach produces the greatest improvement in alarm fatigue and psychological well-being.
Participants will:
Attend weekly group sessions for their assigned intervention over the course of [8 weeks].
Practice the assigned technique regularly between sessions as instructed.
Complete questionnaires assessing alarm fatigue and psychological well-being before and after the intervention.
详细描述
This clinical trial was designed to address a gap in the literature regarding effective mind-body approaches for reducing alarm fatigue and supporting psychological well-being among intensive care unit (ICU) nurses. Alarm fatigue is a common and serious concern in ICUs, and interventions that improve nurses' mental health may also enhance patient safety. In this study, three mind-body-based interventions-Benson Relaxation Technique (BRT), mindfulness-based stress reduction meditation (MBSR), and breathing therapy-will be compared in terms of their effects on alarm fatigue and psychological well-being. The comparative findings from this trial are expected to help identify the most effective mind-body-based approach for ICU nurses and support its wider implementation in clinical practice.
Hypotheses
H₀: BRT, MBSR, and breathing therapy have no significant effect on alarm fatigue and psychological well-being in ICU nurses.
H₁: BRT, MBSR, and breathing therapy have a significant effect on alarm fatigue and psychological well-being in ICU nurses.
Study Design This study will employ a four-arm, assessor-blinded, randomized controlled trial design.
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)
盲法说明
Outcome assessors and the statistician will be blinded to group allocation. Due to the nature of mind-body interventions, participants and intervention providers cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Bachelor's degree or higher in nursing
- •At least 6 months' experience in a tertiary intensive care unit
- •Cognitive and physical ability to complete study forms and perform the assigned exercise with the researcher
- •Willingness to participate and provide written informed consent
排除标准
- •Diagnosed psychological disorders requiring treatment (e.g., anxiety, panic disorder, depression)
- •Not actively working during the study period due to leave (e.g., maternity leave, annual leave)
- •Concurrent participation in another relaxation exercise program (e.g., yoga, visualization)
- •Withdrawal request during the intervention period
- •Missing two consecutive weekly group sessions
研究组 & 干预措施
Benson Relaxation Technique Group
Participants will receive weekly 30-minute group sessions for 8 weeks to practice the Benson Relaxation Technique under the guidance of a trained instructor. They will also be instructed to perform daily home practice.
干预措施: Benson Relaxation Technique (Behavioral)
Mindfulness-Based Stress Reduction Meditation Group
Participants will attend weekly 30-minute group sessions for 8 weeks, focusing on seated mindfulness meditation and mindful breathing exercises. They will also be encouraged to practice daily at home.
干预措施: Mindfulness-Based Stress Reduction Meditation (Behavioral)
Breathing Therapy Group
Participants will attend weekly 30-minute group sessions for 8 weeks, performing guided breathing exercises designed to reduce stress and promote relaxation. Daily home practice will be encouraged.
干预措施: Breathing Therapy (Behavioral)
Control Group
Participants will not receive any intervention during the study period and will continue their usual routine. After the study ends, they will be offered the opportunity to participate in one of the intervention programs.
结局指标
主要结局
Psychological Well-Being
时间窗: Baseline, at the end of week 4, at the end of week 8, and at the end of week 10
Psychological well-being will be assessed using the Turkish version of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Higher scores indicate better well-being.
Alarm Fatigue
时间窗: Baseline, at the end of week 4, at the end of week 8, and at the end of week 10
Alarm fatigue will be measured using the Turkish version of the Healthcare Technology Foundation's Alarm Fatigue Questionnaire, which assesses frequency and perception of alarm-related fatigue among ICU nurses. Higher scores indicate greater fatigue.
次要结局
未报告次要终点
研究者
Hacer Eroglu
Assistant Professor, PhD, RN
Hacettepe University