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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06143826
Other study ID # 24246
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2023
Est. completion date January 18, 2024

Study information

Verified date March 2024
Source Atlas University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The research is a pre-test, post-test, and cross-sectional research. After explaining the purpose of the study to the caregivers who met the inclusion criteria, the Information Form, the Depression Anxiety Stress-21 Scale (DAS-21), and the Zarit Care Burden Scale will be administered. Then, progressive muscle relaxation exercises will be applied to caregivers. During the interview, the audio recording of the exercise will be given to them. Also, contact information (caregiver and researcher) will be shared mutually.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 18, 2024
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Progressive muscle relaxation exercises
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.

Locations

Country Name City State
Turkey Alzheimer daily life home Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Atlas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caregiver burden 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. At the end of the 3 months, the Zarit caregiver burden scale will be applied.
Secondary Depression, anxiety and stress 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. At the end of the 3 months, the Depression, anxiety and stress scale-21 will be applied.
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