Caregiver BurdenNCT06143826
Progressive Muscle Relaxation Exercise on Care Burden, Depression, Anxiety, and Stress Levels in Dementia Caregivers
A study testing Progressive muscle relaxation exercises in people with Caregiver Burden and Dementia, run by Atlas University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Dementia
- What is being tested?
- Progressive muscle relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Jan 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Providing care for less than 3 months
- Providing paid care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Caregiver Burden, Dementia
- Being tested
- Progressive muscle relaxation exercises
- Medical subject headings
- Caregiver Burden, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxation exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dementia caregiver | Experimental | Caregivers will be asked to perform progressive muscle relaxation exercises 3 days a week for 3 months. Receives: Other: Progressive muscle relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the 3 months, the Zarit caregiver burden scale will be applied.
Secondary outcomes (1)
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.
Measured: At the end of the 3 months, the Depression, anxiety and stress scale-21 will be applied.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The research is a pre-test, post-test, cross-sectional, descriptive research.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Baykal, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143826
- Sponsor's protocol ID
- 24246
- Status last verified
- Jun 2024
- First submitted
- 11 Nov 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Muscle Relaxation Exercise on Care Burden, Depression, Anxiety and Stress Levels in Dementia Caregivers
- ClinicalTrials.gov ID
- NCT06143826
- Acronym / sponsor ID
- 24246
- Conditions
- Caregiver Burden, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research is a pre-test, post-test, cross-sectional, descriptive research.
| Arm | Type | Receives |
|---|---|---|
| Dementia caregiver | Experimental | Other: Progressive muscle relaxation exercisesCaregivers will be asked to perform progressive muscle relaxation exercises 3 days a week for 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Providing care for less than 3 months
- Providing paid care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive muscle relaxation exercisesProgressive 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. | Other | Dementia caregiver |
Primary outcome
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.
1 secondary outcome
Depression, anxiety and stress
Time frame: At the end of the 3 months, the Depression, anxiety and stress scale-21 will be applied.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation exercises in people with Caregiver Burden and Dementia, run by Atlas University 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 8 inclusion and 2 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 18 Jun 2024. 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?
Caregiver burden (time frame: At the end of the 3 months, the Zarit caregiver burden scale will be applied.). 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 18 Jun 2024.