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| Name | Class |
|---|---|
| Hacettepe University | OTHER |
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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.
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:
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:
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The Intervention Group will be given breathing therapy and Benson relaxation technique training for 6 weeks. |
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| Control Group | No Intervention | No intervention will be applied to the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Hulya Nuray Bayraktar, Master's Stu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulhane Training and Education Hospital | Ankara | Etlik | 06010 | Turkey (Türkiye) |
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randomized controlled trial
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| From week 6 to week 8 |
| 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. | From week 6 to week 8 |
| 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. | From week 6 to week 8 |
| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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