Clinical trial NCT06997523: Effects of Breathing Therapy and Benson Relaxation Technique on Caregivers of Alzheimer's Patients
Official title: Effect of Breathing Therapy and Benson Relaxation Technique on Caregiver Burden, Perceived Stress and Self-Efficacy Among Alzheimer's Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Caregiver Burden
Caregiver Stress
Caregiver
Caregiver Burden of People With Dementia
Self Efficacy
Keywords: Alzheimer
Caregiver
Self Efficacy
Stress
Caregiver Burden
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2025-05-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: OTHER

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 March 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.

Detailed description: The intervention in this study consists of two evidence-based non-pharmacological techniques: the 4-7-8 relaxing breathing technique and the Benson Relaxation Technique. These methods were delivered in a structured format over six weeks to support caregivers of individuals diagnosed with Alzheimer's disease. The 4-7-8 breathing technique is a rhythmic breathing practice designed to induce physiological calm by modulating the autonomic nervous system. The specific procedure followed was:

* Participants were seated comfortably with a straight posture and used provided eye masks to minimize visual distractions.
* The tongue was placed behind the upper front teeth and maintained in this position throughout the exercise.
* A full exhalation was performed through the mouth while producing a soft whooshing sound.
* This was followed by a quiet nasal inhalation for 4 seconds, breath-holding for 7 seconds, and a controlled exhalation through the mouth over 8 seconds.
* This cycle was repeated approximately three times per minute, totaling 30 cycles in a 10-minute session.

The Benson Relaxation Technique, widely used in mind-body therapy, aims to elicit the relaxation response through passive focus and muscular relaxation. The steps included:

* Selecting a personal word or phrase (e.g., "peace," "health," "love") to silently repeat during exhalation.
* Sitting quietly with eyes closed, participants gradually relaxed all major muscle groups from feet to head.
* While breathing naturally, they repeated the chosen word silently on each exhalation.
* A passive attitude was encouraged; distracting thoughts were acknowledged and released without judgment, redirecting attention to the breath and word.
* Sessions concluded with a quiet reorientation period before standing. Inclusion criteria: Adults aged 18-65 who were the primary caregivers of individuals diagnosed with Alzheimer's disease for at least six months; at least primary school graduates; cognitively and physically able to perform the exercises and complete forms; and provided informed consent.

Exclusion criteria: Individuals with psychological disorders (e.g., anxiety, depression), advanced cardiac, pulmonary (e.g., COPD, asthma), or oncological conditions; communication impairments (vision, hearing, or speech); those undergoing hospitalization or surgery during the study period; or those already engaged in other structured relaxation methods such as yoga or meditation.

Rationale: Caregivers of Alzheimer's patients frequently experience chronic stress and burden, leading to emotional exhaustion, physical health issues, and reduced quality of life. Breathing-based and meditative interventions offer accessible, cost-effective strategies to counteract these effects and improve psychological resilience.

Study Design Notes:

* This is a randomized, controlled.
* Participants were assigned to groups using a computer-based randomization tool.
* All sessions were held face-to-face in groups of ≤10 participants, and all interventions were delivered by the same researcher to ensure standardization.

This structured intervention model was designed to provide both physiological relaxation (via controlled breathing) and psychological relief (via cognitive disengagement and passive awareness), aiming to support caregiver well-being through an integrative mind-body approach.

Statistical Analysis: Data were analyzed using SPSS version 23.0. Groups were anonymized as "A" and "B". Normality was evaluated via Shapiro-Wilk test, skewness-kurtosis values, and Q-Q plots. Parametric tests (Student's t-test, paired samples t-test, ANOVA) were used for normally distributed data, while non-parametric tests (Mann-Whitney U, Friedman) were applied otherwise. Categorical variables were analyzed using chi-square tests. Descriptive statistics included means ± SD or medians (min-max). Cronbach's alpha was calculated for scale reliability. A p-value \<0.05 was considered statistically significant.

This study received ethical approval from the Hacettepe University Clinical Research Ethics Committee under approval numbers 2024/12-01 and 2024/23-11, dated June 26, 2024, and December 3, 2024, respectively. Additionally, regulatory approval was obtained from the Turkey Medicines and Medical Devices Agency with decision number E-85521274-000-3587573 dated January 16, 2025. All participants provided written informed consent prior to participation. Confidentiality and data security were strictly maintained throughout the study to protect participant privacy.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in caregiver burden as measured by the Caregiver Burden Scale for Dementia
timeFrame: Assessed at baseline (week 0), week 2, week 4, week 6 (end of intervention)
measure: Change in Perceived Stress as Measured by the Perceived Stress Scale
timeFrame: Assessed at baseline (week 0), week 2, week 4, week 6 (end of intervention)
measure: Change in Self-Efficacy as Measured by the General Self-Efficacy Scale
timeFrame: Assessed at baseline (week 0), week 2, week 4, week 6 (end of intervention)
Secondary outcomes:
measure: Change in Caregiver Burden Two Weeks After the Intervention as Measured by the Caregiver Burden Scale for Dementia
timeFrame: From week 6 to week 8
measure: Change in Perceived Stress Two Weeks After the Intervention as Measured by the Perceived Stress Scale
timeFrame: From week 6 to week 8
measure: Change in Self-Efficacy Two Weeks After the Intervention as Measured by the General Self-Efficacy Scale
timeFrame: From week 6 to week 8
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Education Hospital
state: Etlik
Study officials:
name: Hulya Nuray Bayraktar, Master's Stu
role: PRINCIPAL_INVESTIGATOR
References: