PARKINSON DISEASE (Disorder)NCT07876830
Effect of Artificial Intelligent-based Training and Benson Relaxation Exercises on Caregiver Burden and Stress Levels in Caregivers of Patients With Parkinson's Disease
A study testing artificial intelligent-based training and artificial intelligent-based Benson's relaxation exercise in people with PARKINSON DISEASE (Disorder) and Caregiver Burden, run by Ataturk University.
Trial summary
The aim of this study is to evaluate the effect of artificial intelligence-supported training and the Benson relaxation exercise on the care burden and stress levels of caregivers of people with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Caregiver Burden, Caregiver Stress
- What is being tested?
- artificial intelligent-based training and artificial intelligent-based Benson's relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Be 18 years of age or older
- Be a family member of the patient (spouse, daughter, son, etc.)
- Living in the same household as the patient
- Having cared for the patient for at least 6 months
- Being the primary caregiver responsible for the patient's care
- There being no paid staff member in the home to assist the caregiver
Show all 9Show fewer
- Having no health issues that prevent communication
- Being able to read and write
- Having access to a phone for communication
Who cannot join
- Having visual, auditory, or cognitive communication barriers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Artificial Intelligent-based Training and Benson Relaxation Exercises on Caregiver Burden and Stress Levels in Parkinson's Disease
The aim of this study is to evaluate the effect of artificial intelligence-supported training and the Benson relaxation exercise on the care burden and stress levels of caregivers of people with Parkinson's disease. In the study, caregivers of people with Parkinson's disease will receive training on caring for people with Parkinson's disease and on the Benson relaxation exercise. The training sessions will be conducted using an artificial intelligence-based module. Participants will be randomly assigned to three groups: a training group, an exercise group, and a control group. A caregiver information form, the Modified Hoehn and Yahr Scale, the Zarit Caregiver Burden Scale, and the Caregiver Stress Scale will be used to collect pretest data from all participants during the initial interview. The training sessions for the experimental group will last 4 weeks. No training will be provided to the control group. Four weeks later, the Zarit Caregiver Burden Scale and the Caregiver Stress Scale will be used to collect final test data from the experimental and control groups.
The hypotheses related to this study are as follows:
- Artificial intelligence-supported training provided to caregivers of people with Parkinson's disease affects the burden of care.
- The Benson relaxation exercise provided to caregivers of people with Parkinson's disease affects the burden of care.
- Artificial intelligence-supported training provided to caregivers of people with Parkinson's disease affects stress levels.
- The Benson relaxation exercise administered to caregivers of people with Parkinson's disease affects stress levels.
Read the detailed description
Given the progressive nature of Parkinson's disease, individuals experience a progressive decline in their ability to perform daily activities. In such cases, they require support and assistance. People with Parkinson's are generally cared for by spouses, adult children, close relatives, or other family members. Caregivers are exposed to stress and the burden of care. It has been noted that providing caregivers with regular training on managing the disease process, along with follow-up support after the training, can reduce the caregiver's anxiety and facilitate the management of the patient's care. The use of complementary and alternative methods has been steadily increasing in recent years. The Benson relaxation technique, one of the most useful and well-known non-pharmacological interventions, is a reliable method that can alleviate various physical and mental symptoms such as anxiety, stress, and pain.
The aim of this study is to evaluate the effect of artificial intelligence-supported training and the Benson relaxation exercise on the care burden and stress levels of caregivers of people with Parkinson's disease.
In this study, caregivers in the experimental group will receive training on Parkinson's disease care and the Benson relaxation exercise. 1. The experimental group will receive training on Parkinson's disease and on managing common issues associated with the disease. The training content was prepared by the researcher through a review of the literature and consultation with experts in the field. 2. The training for the experimental group, which includes the Benson relaxation exercise, will cover the definition, benefits, and steps for performing the Benson relaxation exercise.
To enable participants to continue the training and the Benson relaxation exercise module at home, the AI-based module will be downloaded to their phones via a link sent by the researcher. The training provided to the experimental groups will last 4 weeks. Throughout the 4 weeks, the researcher will monitor participants' engagement with the training via the AI module. No training will be provided to the control group.
- Being tested
- artificial intelligent-based training, artificial intelligent-based Benson's relaxation exercise
- Keywords
- Parkinson's disease; caregivers; burden; stress, Benson exercises; Training, artificial intelligent
- Medical subject headings
- Parkinson Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligent-based trainingBehavioural
experimental group
artificial intelligent-based Benson's relaxation exerciseBehavioural
experimental group
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | Artificial intelligent-based training Receives: Behavioral: artificial intelligent-based training |
| exercises group | Experimental | Artificial intelligent-based Benson's relaxation exercises Receives: Behavioral: artificial intelligent-based Benson's relaxation exercise |
| control group | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Caregiver Burden Scale
This is a measure used to assess the stress experienced by caregivers of individuals requiring care or the elderly. The measurement tool consists of 22 items. The items are Likert-type, and each item is rated on a scale of 0 to 4, using the response options "never," "rarely," "sometimes," "often," or "almost always." A score ranging from 0 to 88 is possible on this scale. A high scale score indicates a high level of distress.
Measured: The scale will be completed at the start of the study and 4 weeks after the completion of training and exercise.
Caregiver Stress Scale
It was developed to measure the caregiving burden. It consists of 13 items. There is at least one item for each category: physical, social, work, financial, and time. On the scale, a score of 7 or higher indicates a higher level of stress.
Measured: The scale will be completed at the start of the study and 4 weeks after the completion of training and exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur Kırkıncı, Ataturk University
- Investigators
- MEHTAP TAN, PROFESSOR DOCTOR, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876830
- Sponsor's protocol ID
- NRS_FNK_AU_01102026
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligent-based Training and Benson Relaxation Exercises on Caregiver Burden and Stress Levels in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07876830
- Acronym / sponsor ID
- NRS_FNK_AU_01102026
- Keywords
- Parkinson's disease; caregivers; burden; stress, Benson exercises; Training, artificial intelligent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 15 Oct 2026 (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 aim of this study is to evaluate the effect of artificial intelligence-supported training and the Benson relaxation exercise on the care burden and stress levels of caregivers of people with Parkinson's disease. In the study, caregivers of people with Parkinson's disease will receive training on caring for people with Parkinson's disease and on the Benson relaxation exercise. The training sessions will be conducted using an artificial intelligence-based module. Participants will be randomly assigned to three groups: a training group, an exercise group, and a control group. A caregiver information form, the Modified Hoehn and Yahr Scale, the Zarit Caregiver Burden Scale, and the Caregiver Stress Scale will be used to collect pretest data from all participants during the initial interview. The training sessions for the experimental group will last 4 weeks. No training will be provided to the control group. Four weeks later, the Zarit Caregiver Burden Scale and the Caregiver Stress Scale will be used to collect final test data from the experimental and control groups.
The hypotheses related to this study are as follows:
- Artificial intelligence-supported training provided to caregivers of people with Parkinson's disease affects the burden of care.
- The Benson relaxation exercise provided to caregivers of people with Parkinson's disease affects the burden of care.
- Artificial intelligence-supported training provided to caregivers of people with Parkinson's disease affects stress levels.
- The Benson relaxation exercise administered to caregivers of people with Parkinson's disease affects stress levels.
Detailed description
Given the progressive nature of Parkinson's disease, individuals experience a progressive decline in their ability to perform daily activities. In such cases, they require support and assistance. People with Parkinson's are generally cared for by spouses, adult children, close relatives, or other family members. Caregivers are exposed to stress and the burden of care. It has been noted that providing caregivers with regular training on managing the disease process, along with follow-up support after the training, can reduce the caregiver's anxiety and facilitate the management of the patient's care. The use of complementary and alternative methods has been steadily increasing in recent years. The Benson relaxation technique, one of the most useful and well-known non-pharmacological interventions, is a reliable method that can alleviate various physical and mental symptoms such as anxiety, stress, and pain.
The aim of this study is to evaluate the effect of artificial intelligence-supported training and the Benson relaxation exercise on the care burden and stress levels of caregivers of people with Parkinson's disease.
In this study, caregivers in the experimental group will receive training on Parkinson's disease care and the Benson relaxation exercise. 1. The experimental group will receive training on Parkinson's disease and on managing common issues associated with the disease. The training content was prepared by the researcher through a review of the literature and consultation with experts in the field. 2. The training for the experimental group, which includes the Benson relaxation exercise, will cover the definition, benefits, and steps for performing the Benson relaxation exercise.
To enable participants to continue the training and the Benson relaxation exercise module at home, the AI-based module will be downloaded to their phones via a link sent by the researcher. The training provided to the experimental groups will last 4 weeks. Throughout the 4 weeks, the researcher will monitor participants' engagement with the training via the AI module. No training will be provided to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Behavioral: artificial intelligent-based trainingArtificial intelligent-based training |
| exercises group | Experimental | Behavioral: artificial intelligent-based Benson's relaxation exerciseArtificial intelligent-based Benson's relaxation exercises |
| control group | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be 18 years of age or older
- Be a family member of the patient (spouse, daughter, son, etc.)
- Living in the same household as the patient
- Having cared for the patient for at least 6 months
- Being the primary caregiver responsible for the patient's care
Key exclusion criteria (1 listed)
- Having visual, auditory, or cognitive communication barriers
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 |
|---|---|---|
| artificial intelligent-based trainingexperimental group | Behavioural | training group |
| artificial intelligent-based Benson's relaxation exerciseexperimental group | Behavioural | exercises group |
Primary outcome
Zarit Caregiver Burden Scale
Time frame: The scale will be completed at the start of the study and 4 weeks after the completion of training and exercise.
This is a measure used to assess the stress experienced by caregivers of individuals requiring care or the elderly. The measurement tool consists of 22 items. The items are Likert-type, and each item is rated on a scale of 0 to 4, using the response options "never," "rarely," "sometimes," "often," or "almost always." A score ranging from 0 to 88 is possible on this scale. A high scale score indicates a high level of distress.
Caregiver Stress Scale
Time frame: The scale will be completed at the start of the study and 4 weeks after the completion of training and exercise.
It was developed to measure the caregiving burden. It consists of 13 items. There is at least one item for each category: physical, social, work, financial, and time. On the scale, a score of 7 or higher indicates a higher level of stress.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
MEHTAP TAN, PROFESSOR DOCTOR principal investigator
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing artificial intelligent-based training and artificial intelligent-based Benson's relaxation exercise in people with PARKINSON DISEASE (Disorder) and Caregiver Burden, run by Ataturk University.
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 9 inclusion and 1 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FATMA N KIRKINCI, REGISTRY NURSE (05342452022, fatmanurkirkinci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Caregiver Burden Scale (time frame: The scale will be completed at the start of the study and 4 weeks after the completion of training and exercise.). 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 21 Oct 2026.