- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06143826
Progressive Muscle Relaxation Exercise on Care Burden, Depression, Anxiety, and Stress Levels in Dementia Caregivers
Progressive Muscle Relaxation Exercise on Care Burden, Depression, Anxiety and Stress Levels in Dementia Caregivers
Dementia, which leads to deterioration in cognitive and behavioral functions, is a chronic progressive disease. Since the diagnosis is made, the care needs of the patients increase. In the later stages of the disease, it becomes completely dependent on the caregiver.
they are coming. Caregiving is performed by family members in developing countries such as Turkey. Family members face many difficulties in their social, work, and daily lives after they start to care. These difficulties are the burden of caregiving is called. Caregivers who perceive the burden of care also experience anxiety, stress, and depression. Jacobson progressive muscle relaxation in coping with these problems exercises can be used. This study was planned to examine the effects of progressive muscle relaxation exercises on anxiety, stress, depression, and caregiver burden in dementia caregivers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34450
- Alzheimer daily life home
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be over 18 years old
- Being literate
- Not having difficulties in verbal communication
- Have been caring for at least 3 months
- Being able to provide care for free
- Being the primary caregiver of the patient
- Not having a psychiatric diagnosis
- Not using medication for psychiatric illness
Exclusion Criteria:
- Providing care for less than 3 months
- Providing paid care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dementia caregiver
Caregivers will be asked to perform progressive muscle relaxation exercises 3 days a week for 3 months.
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Progressive muscle relaxation exercises involve contracting and relaxing 16 muscle groups in the body (hand, upper arm, forearm, forehead, nose, cheek, chin, neck, shoulder, chest, abdomen, waist, stomach, calf, hip, foot).
During the exercise, the individual perceives the changes in the muscles during the contraction and relaxation of the muscles.
Relaxation exercise is applied along with correct and deep breathing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver burden
Time Frame: At the end of the 3 months, the Zarit caregiver burden scale will be applied.
|
The Zarit caregiver burden scale will be evaluated before and after the intervention.
Five-point Likert-type scale and it consists of 22 statements.
The scale has no subgroups.
According to the score obtained from the scale: 88-61 points is a severe burden, 60-41 points is moderately severe, 40-21 points is mild to moderate, and less than 21 points is a mild or no burden.
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At the end of the 3 months, the Zarit caregiver burden scale will be applied.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression, anxiety and stress
Time Frame: At the end of the 3 months, the Depression, anxiety and stress scale-21 will be applied.
|
Depression, anxiety and stress scale will be evaluated before and after the intervention.
There are 7 items each to measure depression, anxiety, and stress dimensions on the scale.
The first 7 questions in the scale are anxiety, the 7 questions between 8-14 are depression, and last 7 questions 15-21 are also about stress.
It is a 4-point Likert type.
High scores from the scale indicate depression, anxiety and stress.
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At the end of the 3 months, the Depression, anxiety and stress scale-21 will be applied.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24246
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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