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

Hacer Eroglu

Status: Active, not recruiting

Conditions: Alarm Fatigue in Intensive Care Unit Nurses; Psychological Well-Being in Intensive Care Unit Nurses

Treatments: Behavioral: Mindfulness-Based Stress Reduction Meditation; Behavioral: Breathing Therapy; Behavioral: Benson Relaxation Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07124364

Record 5

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 4 patient groups

Benson Relaxation Technique Group

Experimental group

Description:

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.

Treatment:

Behavioral: Benson Relaxation Technique

Mindfulness-Based Stress Reduction Meditation Group

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction Meditation

Breathing Therapy Group

Experimental group

Description:

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.

Treatment:

Behavioral: Breathing Therapy

Control Group

No Intervention group

Description:

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.