HemiplegiaNCT06232681
The Effect of Progressive Relaxation Exercises Applied to Caregivers on Caregiving Burden and Meaning of Life
A study testing Progressive relaxation exercise in people with Hemiplegia, run by kıvan çevik kaya at 1 site in Turkey (Türkiye).
Trial summary
This randomised controlled experimental type study will be conducted with family members who care for the relatives of hemiplegic patients who are hospitalised in Manisa Merkezefendi and Turgutlu State Hospital Physical Therapy Services. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Progressive relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jul 2023to 30 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family members who have no communication problems,
- Who are 18 years of age or older,
- Whose patient will be hospitalised in the clinic for at least one month,
- Who agree to participate in the study will be recruited.
Who cannot join
- Individuals who have communication problems,
- The caregiver is not a family member,
- are 18 years of age or younger,
- The patient stays in the clinic for less than one month,
- Has previously received progressive relaxation training, and who do not agree to participate in the study will be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Manisa Celal Bayar University
Manisa, Yunusemre
Kıvan ÇEVİK KAYA
Funda AKTÜRK
About this study
Official title: The Effect of Progressive Relaxation Exercises Applied to Family Members Caregiving for Hemiplegic Patients on Caregiving Burden and Meaning of Life
This randomised controlled experimental type study will be conducted with family members who care for the relatives of hemiplegic patients who are hospitalised in Manisa Merkezefendi and Turgutlu State Hospital Physical Therapy Services.
Read the detailed description
The population of the study will consist of the caregivers of hemiplegic patients receiving treatment in the clinic on the specified dates in Turgutlu State Hospital and Manisa Merkezefendi State Hospital Physical Therapy Service. The sample will consist of individuals who meet the inclusion criteria. Individuals in Turgutlu State Hospital will constitute the intervention group of the study and individuals in Manisa Merkezefendi State Hospital will constitute the control group of the study. The aim of this study was to determine the effect of progressive relaxation exercises applied to family members caring for hemiplegic patients on caregiving burden and meaning of life. In the intervention group, those who agree to participate in the study will be asked to fill in the Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. Relaxation exercises will be explained and demonstrated by the researcher (Funda AKTÜRK) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. You will be asked to perform these exercises after listening to the video (CD). Relaxation exercises are exercises based on stretching and relaxing your muscles. Before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again. In the Control Group, those who agree to participate in the study will be asked to fill in the;Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. The control group will be asked to fill in the forms at the same time as the intervention group without any intervention. If requested, progressive relaxation exercises will be applied to the control group after the end of the study
- Conditions
- Hemiplegia
- Being tested
- Progressive relaxation exercise
- Keywords
- progressive relaxation exercise, burden, caregiver, the meaning of life
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exerciseBehavioural
The intervention group will take one month progressive relaxation exercise starting from the hospitalisation to the clinic
| Study group | Role | What they receive |
|---|---|---|
| Progressive relaxation exercise application | Experimental | Progressive relaxation exercise practice Those who agree to participate in the study will be asked to fill in the Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. Relaxation exercises will be explained and demonstrated by the researcher (Funda AKTÜRK) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. You will be asked to perform these exercises after listening to the video (CD). Relaxation exercises are exercises based on stretching and relaxing your muscles. Before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again. Receives: Behavioral: Progressive relaxation exercise |
| Control group | No intervention | The participants in the control group also filled in the data collection tools without undergoing any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care burden
Caregiving Burden Scale was used. The scale has a Likert-type evaluation ranging from 0 to 4 in the form of never, rarely, sometimes, frequently, often, or almost always. A minimum score of 0 and a maximum score of 88 can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high scale score indicates that the distress experienced is high.
Measured: 30 day
The meaning and purpose of life
Meaning and Purpose of Life Scale was used. The Life's Meaning and Purpose Scale, which is prepared in Likert style and answered by marking one of the options of strongly agree, agree, undecided, disagree and strongly disagree according to frequency, consists of a total of (17) items including (11) positive and (6) negative statements. The options ticked for positive statements are evaluated by scoring as strongly agree (5), agree (4), undecided (3), disagree (2) and strongly disagree (1) respectively, while the options ticked for negative statements are evaluated by scoring in reverse order as strongly agree (1), agree (2), undecided (3), disagree (4) and strongly disagree (5). The lowest score that can be obtained from the scale is (17x1=17) and the highest score is (17x5=85). A high score indicates a high level of meaning in individuals' lives, while a low score indicates a low level of meaning.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start13 Jul 2023
- Primary completion19 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- kıvan çevik kaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, kıvan çevik kaya, Manisa Celal Bayar University
- Investigators
- Funda AKTÜRK, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232681
- Sponsor's protocol ID
- MCBU-K-CEVIK-003
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be given if it's necessary and if it is not problem for ethical office.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises Applied to Family Members Caregiving for Hemiplegic Patients on Caregiving Burden and Meaning of Life
- ClinicalTrials.gov ID
- NCT06232681
- Acronym / sponsor ID
- MCBU-K-CEVIK-003
- Conditions
- Hemiplegia
- Keywords
- progressive relaxation exercise, burden, caregiver, the meaning of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- kıvan çevik kayaUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 19 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 31 Jan 2024 (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.
This randomised controlled experimental type study will be conducted with family members who care for the relatives of hemiplegic patients who are hospitalised in Manisa Merkezefendi and Turgutlu State Hospital Physical Therapy Services.
Detailed description
The population of the study will consist of the caregivers of hemiplegic patients receiving treatment in the clinic on the specified dates in Turgutlu State Hospital and Manisa Merkezefendi State Hospital Physical Therapy Service. The sample will consist of individuals who meet the inclusion criteria. Individuals in Turgutlu State Hospital will constitute the intervention group of the study and individuals in Manisa Merkezefendi State Hospital will constitute the control group of the study. The aim of this study was to determine the effect of progressive relaxation exercises applied to family members caring for hemiplegic patients on caregiving burden and meaning of life. In the intervention group, those who agree to participate in the study will be asked to fill in the Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. Relaxation exercises will be explained and demonstrated by the researcher (Funda AKTÜRK) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. You will be asked to perform these exercises after listening to the video (CD). Relaxation exercises are exercises based on stretching and relaxing your muscles. Before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again. In the Control Group, those who agree to participate in the study will be asked to fill in the;Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. The control group will be asked to fill in the forms at the same time as the intervention group without any intervention. If requested, progressive relaxation exercises will be applied to the control group after the end of the study
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive relaxation exercise application | Experimental | Behavioral: Progressive relaxation exerciseProgressive relaxation exercise practice Those who agree to participate in the study will be asked to fill in the Patient and Patient Relative Form, Cheltanhams Patient Classification Scale, Caregiving Burden Scale and Meaning and Purpose of Life Scale, which include personal information and information about the patient. Relaxation exercises will be explained and demonstrated by the researcher (Funda AKTÜRK) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. You will be asked to perform these exercises after listening to the video (CD). Relaxation exercises are exercises based on stretching and relaxing your muscles. Before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again. |
| Control group | No intervention | –The participants in the control group also filled in the data collection tools without undergoing any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Family members who have no communication problems,
- Who are 18 years of age or older,
- Whose patient will be hospitalised in the clinic for at least one month,
- Who agree to participate in the study will be recruited.
Key exclusion criteria (5 listed)
- Individuals who have communication problems,
- The caregiver is not a family member,
- are 18 years of age or younger,
- The patient stays in the clinic for less than one month,
- Has previously received progressive relaxation training, and who do not agree to participate in the study will be included.
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 relaxation exerciseThe intervention group will take one month progressive relaxation exercise starting from the hospitalisation to the clinic | Behavioural | Progressive relaxation exercise application |
Primary outcome
Care burden
Time frame: 30 day
Caregiving Burden Scale was used. The scale has a Likert-type evaluation ranging from 0 to 4 in the form of never, rarely, sometimes, frequently, often, or almost always. A minimum score of 0 and a maximum score of 88 can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high scale score indicates that the distress experienced is high.
The meaning and purpose of life
Time frame: 30 day
Meaning and Purpose of Life Scale was used. The Life's Meaning and Purpose Scale, which is prepared in Likert style and answered by marking one of the options of strongly agree, agree, undecided, disagree and strongly disagree according to frequency, consists of a total of (17) items including (11) positive and (6) negative statements. The options ticked for positive statements are evaluated by scoring as strongly agree (5), agree (4), undecided (3), disagree (2) and strongly disagree (1) respectively, while the options ticked for negative statements are evaluated by scoring in reverse order as strongly agree (1), agree (2), undecided (3), disagree (4) and strongly disagree (5). The lowest score that can be obtained from the scale is (17x1=17) and the highest score is (17x5=85). A high score indicates a high level of meaning in individuals' lives, while a low score indicates a low level of meaning.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No. The data will be given if it's necessary and if it is not problem for ethical office.
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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.
Funda AKTÜRK principal investigator
Manisa Celal Bayar University
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 relaxation exercise in people with Hemiplegia, run by kıvan çevik kaya 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 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kıvan ÇEVİK KAYA (0 (236) 233 0904, kivancevikk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care burden (time frame: 30 day). The study lists 2 primary outcomes in all. 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 1 Feb 2024.