Effects of Breathing Therapy and Benson Relaxation Technique on Caregivers of Alzheimer's Patients

NCT06997523 | Completed

• 1 other identifier: 2024/12-01; 2024/23- 11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to investigate the effects of respiratory therapy and the Benson Relaxation Technique on caregiver burden, perceived stress, and self-efficacy among caregivers of individuals with Alzheimer's disease. The study will be conducted at the Geriatrics Outpatient Clinic of Gülhane Training and Research Hospital, University of Health Sciences, between February and May 2025. A total of 80 healthy adult caregivers aged 18 to 65 will be enrolled and randomly assigned to either the intervention group (n=40) or the control group (n=40). The intervention group will participate in a structured 6-week program consisting of face-to-face group sessions with a maximum of 10 participants per group, held twice weekly. Each 30-minute session will include 10 minutes of guided respiratory therapy followed by 20 minutes of the Benson Relaxation Technique. The control group will receive routine care without any additional interventions. The purpose of this study is to evaluate whether the combined application of respiratory therapy and the Benson Relaxation Technique results in significant improvements in caregiver outcomes. Caregivers will be assessed using standardized measures, including the Caregiver Burden Scale for Dementia, the Perceived Stress Scale, and the General Self-Efficacy Scale. Assessments will be conducted at baseline (week 0), week 2, week 4, week 6 (end of intervention), and week 8 (two weeks post-intervention). The study is guided by the following hypotheses: H01: Respiratory therapy and the Benson Relaxation Technique have no effect on caregiver burden. H11: Respiratory therapy and the Benson Relaxation Technique reduce caregiver burden. H02: Respiratory therapy and the Benson Relaxation Technique have no effect on perceived stress. H12: Respiratory therapy and the Benson Relaxation Technique reduce perceived stress. H03: Respiratory therapy and the Benson Relaxation Technique have no effect on self-efficacy. H13: Respiratory therapy and the Benson Relaxation Technique improve self-efficacy.

Conditions

Healthy; Caregiver Burden; Caregiver Stress; Caregiver; Caregiver Burden of People With Dementia; Self Efficacy

Keywords

Alzheimer; Caregiver; Self Efficacy; Stress; Caregiver Burden

Outcome Measures

Primary Outcomes (3)

• Change in caregiver burden as measured by the Caregiver Burden Scale for Dementia

  Caregiver burden will be assessed using the Caregiver Burden Scale for Dementia, which includes four sub-dimensions: physical, social, economic, and psychological. The scale consists of 24 items, each rated on a 5-point Likert scale ranging from 1 ("Never") to 5 ("Always"). There are no reverse-coded items. The total score ranges from 24 to 120, with higher scores indicating a greater caregiver burden. Subscale scores and total scores will be compared between the intervention and control groups at each assessment point to evaluate changes over time.

  Assessed at baseline (week 0), week 2, week 4, week 6 (end of intervention)

• Change in Perceived Stress as Measured by the Perceived Stress Scale

  Perceived stress will be assessed using the Perceived Stress Scale for Adults. This scale consists of 14 items designed to measure the degree to which situations in one's life are appraised as stressful. Items are rated on a 5-point Likert scale from 0 ("Never") to 4 ("Very Often"). Items 4, 5, 6, 7, 9, 10, and 13 are reverse-scored. Total scores range from 0 to 56, with higher scores indicating greater levels of perceived stress. Changes in perceived stress will be evaluated by comparing scores at different time points within and between groups.

  Assessed at baseline (week 0), week 2, week 4, week 6 (end of intervention)

• Change in Self-Efficacy as Measured by the General Self-Efficacy Scale

  Self-efficacy will be assessed using the General Self-Efficacy Scale, which includes 10 items aimed at measuring an individual's belief in their ability to cope with a variety of difficult demands. Each item is rated on a 4-point Likert scale ranging from 1 ("Not at all true") to 4 ("Exactly true"). Total scores range from 10 to 40, with higher scores reflecting greater perceived self-efficacy. Group differences and within-group changes over time will be analyzed.

  Assessed at baseline (week 0), week 2, week 4, week 6 (end of intervention)

Secondary Outcomes (3)

• Change in Caregiver Burden Two Weeks After the Intervention as Measured by the Caregiver Burden Scale for Dementia

  From week 6 to week 8

• Change in Perceived Stress Two Weeks After the Intervention as Measured by the Perceived Stress Scale

  From week 6 to week 8

• Change in Self-Efficacy Two Weeks After the Intervention as Measured by the General Self-Efficacy Scale

  From week 6 to week 8

Study Arms (2)

Intervention Group

EXPERIMENTAL

The Intervention Group will be given breathing therapy and Benson relaxation technique training for 6 weeks.

Behavioral: Breath Therapy and Benson Relaxation Technique

Control Group

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Breath Therapy and Benson Relaxation Technique BEHAVIORAL

Relaxing breathing therapy (4-7-8) and Benson relaxation technique will be applied to the intervention group for 6 weeks. No intervention will be made to the control group.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65
• At least primary school graduate
• First degree caregiver of a patient diagnosed with Alzheimer's (continuous caregiver, family member, spouse, etc., or paid continuous caregiver)
• Caring for an individual diagnosed with Alzheimer's for at least 6 months
• Cognitively and physically capable of answering data collection forms and implementing the taught exercise with the researcher Caregivers who agree to participate in the study will be included in the sample.

You may not qualify if:

• Individuals with cognitive and psychological problems (anxiety, panic attacks, depression, etc.)
• Those diagnosed with advanced heart disease, asthma, COPD, and advanced cancer
• Those with communication problems (hearing, vision, speech, etc.)
• Individuals who are hospitalized or undergo surgery, etc. during the study period
• Individuals who are simultaneously continuing another relaxation exercise (yoga, meditation, visualization, etc.) will not be included in the sample.
• In addition, caregivers who indicate that they want to withdraw from the study during the study and who do not attend the weekly group sessions twice in a row will be excluded from the sample.

Sponsors & Collaborators

• Hülya Nuray Bayraktar: lead
• Hacettepe University: collaborator

Study Sites (1)

Gulhane Training and Education Hospital

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Hulya Nuray Bayraktar, Master's Stu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate Student

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 30, 2025
• Study Start: February 19, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 7, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)