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

NCT07124364 | Active Not Recruiting

• 1 other identifier: Record 5
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Alarm fatigue; Psychological well-being; Intensive care nurses; Benson Relaxation Technique; Breathing therapy; Randomized controlled trial; ICU; Nursing intervention

Outcome Measures

Primary Outcomes (2)

• Alarm Fatigue

  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.

  Baseline, at the end of week 4, at the end of week 8, and at the end of week 10

• Psychological Well-Being

  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.

  Baseline, at the end of week 4, at the end of week 8, and at the end of week 10

Study Arms (4)

Benson Relaxation Technique Group

EXPERIMENTAL

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.

Behavioral: Benson Relaxation Technique

Mindfulness-Based Stress Reduction Meditation Group

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Stress Reduction Meditation

Breathing Therapy Group

EXPERIMENTAL

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.

Behavioral: Breathing Therapy

Control Group

NO INTERVENTION

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.

Interventions

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.

Benson Relaxation Technique Group

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.

Mindfulness-Based Stress Reduction Meditation Group

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.

Breathing Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacer Eroglu: lead
• Ankara City Hospital Bilkent: collaborator
• Hacettepe University: collaborator

Study Sites (2)

Ankara Bilkent City Hospital - General Hospital Tower, Internal Medicine and General Intensive Care Units

Ankara, Ankara, 06080, Turkey (Türkiye)

Location

Hacettepe University Hospital

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alert Fatigue, Health Personnel; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Zehra Gok Metin, PhD, RN

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, PhD, RN

Model Details: Four-arm, assessor-blinded, randomized controlled trial with parallel group assignment.

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: July 28, 2025
• Primary Completion: September 15, 2025
• Study Completion: January 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 3 months after publication of the main study results and will remain available for 3 years thereafter.
• Access Criteria: Qualified researchers will be able to request access to de-identified participant data, the study protocol, statistical analysis plan, and informed consent form by contacting the principal investigator via email. Requests must include a methodologically sound proposal and a signed data use agreement. Approved researchers will receive the requested data through secure electronic transfer.

Locations

TU (2)