Caregiver BurnoutNCT06687486
Effect of Autogenic Relaxation Therapy on Caregivers on Perceived Stress Quality of Life and Caregiver Burden
A study testing relaxin and kontrol in people with Caregiver Burnout and Caregiver, run by Seda KARAKAYA ERGUN at 1 site in Turkey (Türkiye).
Trial summary
Caregivers are also faced with multiple stress factors. Autogenic relaxation therapy will help caregivers relax and take time for themselves by getting away from the stressful life they have lived. Although there are various studies on this subject (Chegeni et al. 2018, Seo and Kim 2019, Ramiraz-Garcia et al. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Caregiver Burnout, Caregiver, Care Burden
- What is being tested?
- relaxin and kontrol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2024to 20 Feb 2025
- 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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Being able to answer data collection forms
- Being able to speak Turkish
- Being able to provide continuous or partial care to a patient for at least 3 months
- Being able to communicate
Who cannot join
- Having epilepsy
- Not speaking or understanding Turkish
- Having a neurological disability
- Having had an acute myocardial infarction
- Being diagnosed with schizophrenia and major depression
- Being addicted to alcohol or drugs
- Having a history of loss of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Autogenic Relaxation Therapy on Caregivers on Perceived Stress Quality of Life and Caregiver Burden: a Randomized Controlled Study
Caregivers are also faced with multiple stress factors. Autogenic relaxation therapy will help caregivers relax and take time for themselves by getting away from the stressful life they have lived. Although there are various studies on this subject (Chegeni et al. 2018, Seo and Kim 2019, Ramiraz-Garcia et al. 2020, Wang et al. 2021, Bagheri et all 2021, Ozhanlı and Akyuz 2022), there is no study on caregivers as far as we could reach. As a result of this study, nurses will help caregivers, whom they work one-on-one in most areas, to relax, thus helping to increase the quality of patient care in home environments and contributing to the increase in the quality of life of the caregiver. Thus, caregivers will be able to manage care more actively and effectively both at home and in clinics.
Based on this purpose, the aim of the study is to reduce the anxiety level of caregivers, increase the quality of life and reduce the burden of care after autogenic relaxation therapy to be applied to caregivers.
- Conditions
- Caregiver Burnout, Caregiver, Care Burden
- Being tested
- relaxin, kontrol
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxinBehavioural
caregivers relaxing and care burden
kontrolOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Behavioral: relaxin |
| control | Other | Not described Receives: Other: kontrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Principial
A decrease in the perceived stress scale score indicates a decrease in stress, an increase in the quality of life scale score indicates an increase in the quality of life, and a decrease in the care burden scale score indicates a decrease in the care burden. The secondary outcome measure is the decrease in the Perceived Stress Scale score, the increase in the Quality of Life Scale Score, and the decrease in the care burden scale score after autogenic relaxation therapy applied to caregivers.
Measured: 1 month
Secondary outcomes (1)
second
The secondary outcome measure is that caregivers feel better after autogenic relaxation therapy, are able to perform autogenic relaxation therapy on their own, and are least affected by the disadvantages of the care burden.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start7 Nov 2024
- Primary completion30 Nov 2024 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurnoutStudies 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
- Individuals assigned as intervention and control will complete the research in these groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seda KARAKAYA ERGUN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seda KARAKAYA ERGUN, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687486
- Sponsor's protocol ID
- 2023/369
- Status last verified
- Jun 2024
- First submitted
- 7 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autogenic Relaxation Therapy on Caregivers on Perceived Stress Quality of Life and Caregiver Burden: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06687486
- Acronym / sponsor ID
- 2023/369
- Conditions
- Caregiver Burnout, Caregiver, Care Burden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Seda KARAKAYA ERGUNUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 13 Nov 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.
Caregivers are also faced with multiple stress factors. Autogenic relaxation therapy will help caregivers relax and take time for themselves by getting away from the stressful life they have lived. Although there are various studies on this subject (Chegeni et al. 2018, Seo and Kim 2019, Ramiraz-Garcia et al. 2020, Wang et al. 2021, Bagheri et all 2021, Ozhanlı and Akyuz 2022), there is no study on caregivers as far as we could reach. As a result of this study, nurses will help caregivers, whom they work one-on-one in most areas, to relax, thus helping to increase the quality of patient care in home environments and contributing to the increase in the quality of life of the caregiver. Thus, caregivers will be able to manage care more actively and effectively both at home and in clinics.
Based on this purpose, the aim of the study is to reduce the anxiety level of caregivers, increase the quality of life and reduce the burden of care after autogenic relaxation therapy to be applied to caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Individuals assigned as intervention and control will complete the research in these groups.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: relaxin |
| control | Other | Other: kontrol |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being over 18 years old
- Being able to answer data collection forms
- Being able to speak Turkish
- Being able to provide continuous or partial care to a patient for at least 3 months
- Being able to communicate
Key exclusion criteria (7 listed)
- Having epilepsy
- Not speaking or understanding Turkish
- Having a neurological disability
- Having had an acute myocardial infarction
- Being diagnosed with schizophrenia and major depression
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 |
|---|---|---|
| relaxincaregivers relaxing and care burden | Behavioural | intervention |
| kontrolno intervention | Other | control |
Primary outcome
Principial
Time frame: 1 month
A decrease in the perceived stress scale score indicates a decrease in stress, an increase in the quality of life scale score indicates an increase in the quality of life, and a decrease in the care burden scale score indicates a decrease in the care burden. The secondary outcome measure is the decrease in the Perceived Stress Scale score, the increase in the Quality of Life Scale Score, and the decrease in the care burden scale score after autogenic relaxation therapy applied to caregivers.
1 secondary outcome
second
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Caregiver Burnout
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Recruiting
Caring for the Carer
Care Burden, Care Giving Burden
Not yet recruitingPhase 2
Peer Support for Family Caregivers of Older Adults Living With Dementia
Caregiver Burden, Caregiver Burnout
Enrolling by invitation
Evaluation of the CBSM Program Online and in Person to Reduce Caregiver Burnout
Burnout, Caregiver
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 relaxin and kontrol in people with Caregiver Burnout and Caregiver, run by Seda KARAKAYA ERGUN 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 5 inclusion and 7 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 13 Nov 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?
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?
Principial (time frame: 1 month). 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 13 Nov 2024.