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HealthyNCT06997523

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

A study testing Breath Therapy and Benson Relaxation Technique in people with Healthy and Caregiver Burden, run by Hülya Nuray Bayraktar at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Caregiver Burden, Caregiver Stress
What is being tested?
Breath Therapy and Benson Relaxation Technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Feb 2025to 7 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gulhane Training and Education Hospital

    Ankara, Etlik, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Breathing Therapy and Benson Relaxation Technique on Caregiver Burden, Perceived Stress and Self-Efficacy Among Alzheimer's Caregivers

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.

Read the 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.

Being tested
Breath Therapy and Benson Relaxation Technique
Keywords
Alzheimer, Caregiver, Self Efficacy, Stress, Caregiver Burden
Medical subject headings
Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breath Therapy and Benson Relaxation TechniqueBehavioural

    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.

Study groups in NCT06997523
Study groupRoleWhat they receive
Intervention GroupExperimentalThe Intervention Group will be given breathing therapy and Benson relaxation technique training for 6 weeks.
Receives: Behavioral: Breath Therapy and Benson Relaxation Technique
Control GroupNo interventionNo intervention will be applied to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (3)
  1. Change in Caregiver Burden Two Weeks After the Intervention 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.

    Measured: From week 6 to week 8

  2. Change in Perceived Stress Two Weeks After the Intervention 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.

    Measured: From week 6 to week 8

  3. Change in Self-Efficacy Two Weeks After the Intervention 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.

    Measured: From week 6 to week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study start19 Feb 2025
  3. Primary completion30 Apr 2025
  4. Study completion7 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized controlled trial
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997523
Sponsor's protocol ID
2024/12-01; 2024/23- 11
Status last verified
Jan 2025
First submitted
2 May 2025
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Breath Therapy and Benson Relaxation Technique in people with Healthy and Caregiver Burden, run by Hülya Nuray Bayraktar at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in caregiver burden as measured by the Caregiver Burden Scale for Dementia (time frame: Assessed at baseline (week 0), week 2, week 4, week 6 (end of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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