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NCT Number: NCT07124364

Effects of Relaxation, Mindfulness, and Breathing Therapy on Alarm Fatigue and Psychological Well-being in Intensive Care Nurses

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital - General Hospital Tower, Internal Medicine and General Intensive Care Units, Ankara, Turkey (Türkiye)

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About this study

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.

Study Setting and Duration The trial will be conducted at three ICU centers: the Internal Medicine and General Intensive Care Units of Ankara Bilkent City Hospital - General Hospital Tower, and the Internal Medicine ICUs of Hacettepe University Adult and Oncology Hospitals. Data collection will take place between June 2025 and June 2026.

Institutional Characteristics The Internal Medicine and General ICUs of Ankara Bilkent City Hospital - General Hospital Tower are tertiary-level units serving approximately 140-150 patients daily, with a total of 70 ICU nurses. The Internal Medicine ICUs of Hacettepe University Adult and Oncology Hospitals serve approximately 200 patients daily across four units, staffed by a total of 100 ICU nurses.

Population and Sample The study population will consist of nurses working in the above-mentioned tertiary ICUs. The sample will include nurses who meet the inclusion criteria, volunteer to participate, and provide written and verbal informed consent. Sample size was calculated based on a previous randomized controlled trial by Askar et al. (2024) examining the effects of progressive muscle relaxation on fatigue in ICU nurses. In that study, mean fatigue scores at week 4 were 3.13±1.58 for the intervention group and 4.12±1.70 for the control group, with a statistically significant difference between groups. Using these findings, an effect size of 0.62, a 95% confidence level, 88% power, and α = 0.05, the minimum required sample size was determined as 42 nurses per group, totaling 168 participants.

Inclusion criteria

Age ≥ 18 years

Bachelor's degree or higher in nursing

At least 6 months' experience in a tertiary ICU

Cognitive and physical ability to complete study forms and perform the assigned exercise with the researcher

Voluntary participation with signed informed consent

Exclusion criteria

Diagnosed psychological disorders requiring treatment (e.g., anxiety, panic disorder, depression)

Not actively working during the study period due to leave (e.g., maternity, annual leave)

Concurrent participation in another relaxation exercise program (e.g., yoga, visualization)

Participants will also be withdrawn if they:

Request to leave the study during the intervention period

Miss two consecutive weekly group sessions

Randomization and Blinding Eligible nurses will be randomly assigned (1:1:1:1) to one of the four study arms using www.randomizer.org by the lead researcher. Allocation results will be shared with the second researcher. Interventions will be delivered by a third researcher, while data collection will be performed by a fourth researcher blinded to group allocation. Data analysis will be conducted by a statistician who is also blinded to allocation. Due to the nature of mind-body interventions, participants and the researcher delivering the interventions cannot be blinded; however, the study will maintain assessor blinding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Benson Relaxation Technique

Behavioral

The Benson Relaxation Technique is a structured relaxation method involving the repetition of a word, sound, or phrase while sitting quietly in a comfortable position with eyes closed, combined with passive muscle relaxation. In this study, it will be delivered in weekly 30-minute group sessions for 8 weeks by a trained instructor. Participants will be instructed to practice the technique daily at home for 10-15 minutes.

Mindfulness-Based Stress Reduction Meditation

Behavioral

Mindfulness-Based Stress Reduction meditation is a practice focusing on cultivating awareness of the present moment through seated meditation and mindful breathing. In this study, participants will attend weekly 30-minute group sessions for 8 weeks, guided by an experienced instructor. They will also be encouraged to perform daily mindfulness meditation at home for 10-15 minutes.

Breathing Therapy

Behavioral

Breathing therapy consists of guided breathing exercises designed to promote relaxation, reduce stress, and improve psychological well-being by regulating breathing patterns. In this study, participants will attend weekly 30-minute group sessions for 8 weeks, led by a trained facilitator. Daily home practice of slow deep breathing techniques for 10-15 minutes will be encouraged.

Primary outcomes

  1. Alarm Fatigue

    Time frame: 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.

  2. Psychological Well-Being

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacer Eroglu

Other

Collaborators

  • Ankara City Hospital Bilkent
  • Hacettepe University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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