CaregiverNCT04368780
The Effect Of Progressive Relaxation Exercises On The Care Satisfaction
A study testing Effect of Progressive Muscle Relaxation Combined With Music in people with Caregiver, run by Aksaray University at 2 sites in Turkey (Türkiye).
Trial summary
The increase in the elderly population, insufficiencies in chronic diseases cause an increase in the number of dependent and dependent elderly. This situation negatively affects caregivers with elderly individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver
- What is being tested?
- Effect of Progressive Muscle Relaxation Combined With Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 15 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of the caregiver is 18 years old.
- Giving care to the elderly patient who is dependent on the bed for at least 3 months and above,
- No psychiatric disease diagnosed,
- No vision, speech or hearing problems that would prevent the information given from being understood and the implementation of PMR exercise,
- Individuals providing voluntary care will be included in participating in the research.
Who cannot join
- The age of the caregiver under 18
- Giving care to an elderly person dependent on bed for less than 3 months
- With a diagnosis of psychiatric illness
- Has a vision, speech or hearing problem that will prevent the information given from being understood and the implementation of the PMR exercise,
- Caregivers who do not agree to participate in the research will not be included in the research.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aksaray University Faculty of Health Science
Aksaray, 68100
Aksaray University Health Science Faculty
Aksaray, 68100
About this study
Official title: The Effect Of Progressive Relaxation Exercises On The Care Satisfaction, Caregiver Burden and The Level of Depression Among Caregivers of Bedridden Elderly Patients
The increase in the elderly population, insufficiencies in chronic diseases cause an increase in the number of dependent and dependent elderly. This situation negatively affects caregivers with elderly individuals. nonpharmacological interventions are commonly used to reduce the negative emotions of caregivers due to care. One of these applications is progressive relaxation exercises. This study was planned in a randomized controlled experimental study design to investigate the effect of progressive muscle relaxation exercise. on care satisfaction, care burden and depression level of caregivers who care for bed dependent elderly individuals. The study will consist of 10 interventions, 10 control groups, and 20 caregivers.
Read the detailed description
Today, changes and developments in technology and lifestyles have lengthened average life span and increased the elderly population. The physical and cognitive changes, health problems, new roles such as being retired or widowed and economic losses come one after another for the elderly, and this turns the old age into a period full of difficul ties. Due to these changes in individuals with aging, older individuals make dependent and dependent on care. Caregivers experience care burdens, emotional stress, depression and anxiety during the care process. There are various non-pharmacological applications in the literature aimed at reducing the level of depression and care burden of caregivers. The non-pharmacological methods used in this study for older people's included progressive muscle relaxation exercise.
Objective: In this study, it is aimed to determine the effect of progressive muscle relaxation exercise. on care satisfaction, care burden and depression level of caregivers of bedridden elderly individuals.
Methodology: This is randomized clinical test. The study will consist of 10 interventions, 10 control groups, and 20 caregivers. The progressive muscle relaxation technique combined with music was employed. In order to collect the data, we adopted the interview with form filling technique, using the introductory information form, The Carer's Assessment Of Satısfactıon Index (Cası-TR), the Zarit Caregiver Burden Scale (ZCBS); and the Beck Depression Scale (BDS).
- Conditions
- Caregiver
- Being tested
- Effect of Progressive Muscle Relaxation Combined With Music
- Keywords
- caregiver, older people, depression, progressive muscle relaxation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Progressive Muscle Relaxation Combined With MusicOther
The CD on relaxation exercises developed by the Turkish Psy-chological Associationwas used.In the second of CD 30-min section; relaxation exercises are explained to the accompaniment ofrunning water sounds and verbal instructions. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation. In addition, taking correct breaths is used as a part of the exercise among all relaxation exercises.Steps of Progressive Relaxation Exercise:- breathing exercises- lower extremity exercises- upper extremity exercises- exercise of respiratory muscles.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Individuals who provide home care to an elderly person who is dependent on the bed |
| Experimental group | Experimental | Individuals who provide home care to an elderly person who is dependent on the bed. It is planned that the exercises will be conducted two days a week with the researcher and on the other days by the caregiver herself for a total of eight weeks. Receives: Other: Effect of Progressive Muscle Relaxation Combined With Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Carer's Assessment of Satisfaction Index
The caregivers measure satisfaction with care.
Measured: 2 months
Secondary outcomes (2)
the Zarit Caregiver Burden Scale
Assesses the burden of caregivers.
Measured: 2 months
the Beck Depression Scale
Assesses the level of depression of caregivers.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start15 Mar 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadet ÇAPACI, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368780
- Sponsor's protocol ID
- 2019/24
- Status last verified
- Feb 2022
- First submitted
- 27 Apr 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Progressive Relaxation Exercises On The Care Satisfaction, Caregiver Burden and The Level of Depression Among Caregivers of Bedridden Elderly Patients
- ClinicalTrials.gov ID
- NCT04368780
- Acronym / sponsor ID
- 2019/24
- Conditions
- Caregiver
- Keywords
- caregiver, older people, depression, progressive muscle relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 30 Apr 2020 (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.
The increase in the elderly population, insufficiencies in chronic diseases cause an increase in the number of dependent and dependent elderly. This situation negatively affects caregivers with elderly individuals. nonpharmacological interventions are commonly used to reduce the negative emotions of caregivers due to care. One of these applications is progressive relaxation exercises. This study was planned in a randomized controlled experimental study design to investigate the effect of progressive muscle relaxation exercise. on care satisfaction, care burden and depression level of caregivers who care for bed dependent elderly individuals. The study will consist of 10 interventions, 10 control groups, and 20 caregivers.
Detailed description
Today, changes and developments in technology and lifestyles have lengthened average life span and increased the elderly population. The physical and cognitive changes, health problems, new roles such as being retired or widowed and economic losses come one after another for the elderly, and this turns the old age into a period full of difficul ties. Due to these changes in individuals with aging, older individuals make dependent and dependent on care. Caregivers experience care burdens, emotional stress, depression and anxiety during the care process. There are various non-pharmacological applications in the literature aimed at reducing the level of depression and care burden of caregivers. The non-pharmacological methods used in this study for older people's included progressive muscle relaxation exercise.
Objective: In this study, it is aimed to determine the effect of progressive muscle relaxation exercise. on care satisfaction, care burden and depression level of caregivers of bedridden elderly individuals.
Methodology: This is randomized clinical test. The study will consist of 10 interventions, 10 control groups, and 20 caregivers. The progressive muscle relaxation technique combined with music was employed. In order to collect the data, we adopted the interview with form filling technique, using the introductory information form, The Carer's Assessment Of Satısfactıon Index (Cası-TR), the Zarit Caregiver Burden Scale (ZCBS); and the Beck Depression Scale (BDS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Individuals who provide home care to an elderly person who is dependent on the bed |
| Experimental group | Experimental | Other: Effect of Progressive Muscle Relaxation Combined With MusicIndividuals who provide home care to an elderly person who is dependent on the bed. It is planned that the exercises will be conducted two days a week with the researcher and on the other days by the caregiver herself for a total of eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age of the caregiver is 18 years old.
- Giving care to the elderly patient who is dependent on the bed for at least 3 months and above,
- No psychiatric disease diagnosed,
- No vision, speech or hearing problems that would prevent the information given from being understood and the implementation of PMR exercise,
- Individuals providing voluntary care will be included in participating in the research.
Key exclusion criteria (5 listed)
- The age of the caregiver under 18
- Giving care to an elderly person dependent on bed for less than 3 months
- With a diagnosis of psychiatric illness
- Has a vision, speech or hearing problem that will prevent the information given from being understood and the implementation of the PMR exercise,
- Caregivers who do not agree to participate in the research will not be included in the research.
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 |
|---|---|---|
| Effect of Progressive Muscle Relaxation Combined With MusicThe CD on relaxation exercises developed by the Turkish Psy-chological Associationwas used.In the second of CD 30-min section; relaxation exercises are explained to the accompaniment ofrunning water sounds and verbal instructions. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation. In addition, taking correct breaths is used as a part of the exercise among all relaxation exercises.Steps of Progressive Relaxation Exercise:- breathing exercises- lower extremity exercises- upper extremity exercises- exercise of respiratory muscles. | Other | Experimental group |
Primary outcome
the Carer's Assessment of Satisfaction Index
Time frame: 2 months
The caregivers measure satisfaction with care.
2 secondary outcomes
the Zarit Caregiver Burden Scale
Time frame: 2 months
the Beck Depression Scale
Time frame: 2 months
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 17 Feb 2022.
- Individual participant dataSharing planned: No. We have no plans.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Progressive Muscle Relaxation Combined With Music in people with Caregiver, run by Aksaray University at 2 sites 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 5 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 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
the Carer's Assessment of Satisfaction Index (time frame: 2 months). 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 17 Feb 2022.