Effects of Relaxation, Mindfulness, and Breathing Therapy on Alarm Fatigue and Psychological Well-being in Intensive Care Nurses
NCT ID: NCT07124364
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
168 participants
INTERVENTIONAL
2025-07-28
2026-01-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Benson Relaxation Technique
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 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.
Mindfulness-Based Stress Reduction Meditation
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 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.
Breathing Therapy
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.
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.
No interventions assigned to this group
Interventions
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Benson Relaxation Technique
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Hacettepe University Hospital
UNKNOWN
Hacer Eroglu
OTHER
Responsible Party
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Hacer Eroglu
Assistant Professor, PhD, RN
Principal Investigators
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Zehra Gok Metin, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University
Locations
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Ankara Bilkent City Hospital - General Hospital Tower, Internal Medicine and General Intensive Care Units
Ankara, Ankara, Turkey (Türkiye)
Hacettepe University Hospital
Ankara, Ankara, Turkey (Türkiye)
Countries
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Other Identifiers
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Record 5
Identifier Type: -
Identifier Source: org_study_id
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