StressNCT06449118
Effectiveness of Mindfulness-based Stress Reduction Program
A study testing Mindfulness Stress Reduction Program in people with Stress, run by Muş Alparslan University.
Trial summary
Having a physically disabled child presents serious challenges for parents, not only in the practice of daily living, but also on a psychological and emotional level. In addition to meeting the constant and complex needs of their children, these parents must also maintain their own emotional balance and psychological… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Mindfulness Stress Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Aug 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being able to read and write
- Having a child diagnosed with a physical disability
Who cannot join
- Having more than one physically disabled child
About this study
Official title: The Effect of Mindfulness Based-stress Reduction Program Applied to Parents With Physically Disabled Children on Stress and Quality of Life: A Single-Blind Randomized Controlled Trial
Having a physically disabled child presents serious challenges for parents, not only in the practice of daily living, but also on a psychological and emotional level. In addition to meeting the constant and complex needs of their children, these parents must also maintain their own emotional balance and psychological well-being. In the long term, high stress levels can seriously compromise parents' mental health and reduce their overall quality of life. Therefore, the development of effective stress management strategies and psychological support mechanisms for parents is critical not only for individual well-being but also for the health of family relationships. Mindfulness practices, in this context, emerge as powerful tools with the potential to increase parents' ability to cope with stress and improve emotional well-being. Therefore, this study aims to determine the effect of the mindfulness stress reduction program applied to parents of physically disabled children on stress and quality of life.
- Conditions
- Stress
- Being tested
- Mindfulness Stress Reduction Program
- Keywords
- Mindfulness Stress Reduction Program, physically disabled, parent, quality of life, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Stress Reduction ProgramBehavioural
Mindfulness based-Stress Reduction Program an 8-week program
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Stress Reduction | Active comparator | Mindfulness Stress Reduction Program Receives: Behavioral: Mindfulness Stress Reduction Program |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Attention Awareness Scale
Mindful Attention Awareness Scale(MAAS), measures the general level of awareness of and attentiveness to current processes in daily life. The scale is a six-point Likert-type scale consisting of 15 items. The scale is a 6-point Likert scale including almost always (1), most of the time (2), sometimes (3), rarely (4), very rarely (5), and almost never (6). The MAAS is single-factor and a single total score is obtained from the scale. The lowest score that can be obtained from the scale is 15 and the highest is 90. The higher the score obtained from the scale, the higher the mindfulness level of the individual.
Measured: Two months
Parent Stress Scale
It is a scale developed to measure the stress experienced by parents in their relationships with their children in daily life. The scale is a one-dimensional scale consisting of 16 items. It is a four-point Likert-type scale with the options "always, often, sometimes and never".
Measured: Two months
World Health Organization's Quality of Life (WHOQOL-BREF) Questionnaire
The scale consists of 27 questions in total. This scale, which is completed by the participants, evaluates quality of life from 4 dimensions: physical health domain, psychological domain, social relations domain and environmental domain.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449118
- Sponsor's protocol ID
- c.taskaya
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Based-stress Reduction Program Applied to Parents With Physically Disabled Children on Stress and Quality of Life: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06449118
- Acronym / sponsor ID
- c.taskaya
- Conditions
- Stress
- Keywords
- Mindfulness Stress Reduction Program, physically disabled, parent, quality of life, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 7 Jun 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.
Having a physically disabled child presents serious challenges for parents, not only in the practice of daily living, but also on a psychological and emotional level. In addition to meeting the constant and complex needs of their children, these parents must also maintain their own emotional balance and psychological well-being. In the long term, high stress levels can seriously compromise parents' mental health and reduce their overall quality of life. Therefore, the development of effective stress management strategies and psychological support mechanisms for parents is critical not only for individual well-being but also for the health of family relationships. Mindfulness practices, in this context, emerge as powerful tools with the potential to increase parents' ability to cope with stress and improve emotional well-being. Therefore, this study aims to determine the effect of the mindfulness stress reduction program applied to parents of physically disabled children on stress and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Stress Reduction | Active comparator | Behavioral: Mindfulness Stress Reduction ProgramMindfulness Stress Reduction Program |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being able to read and write
- Having a child diagnosed with a physical disability
Key exclusion criteria (1 listed)
- Having more than one physically disabled child
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 |
|---|---|---|
| Mindfulness Stress Reduction ProgramMindfulness based-Stress Reduction Program an 8-week program | Behavioural | Mindfulness Stress Reduction |
Primary outcome
Mindful Attention Awareness Scale
Time frame: Two months
Mindful Attention Awareness Scale(MAAS), measures the general level of awareness of and attentiveness to current processes in daily life. The scale is a six-point Likert-type scale consisting of 15 items. The scale is a 6-point Likert scale including almost always (1), most of the time (2), sometimes (3), rarely (4), very rarely (5), and almost never (6). The MAAS is single-factor and a single total score is obtained from the scale. The lowest score that can be obtained from the scale is 15 and the highest is 90. The higher the score obtained from the scale, the higher the mindfulness level of the individual.
Parent Stress Scale
Time frame: Two months
It is a scale developed to measure the stress experienced by parents in their relationships with their children in daily life. The scale is a one-dimensional scale consisting of 16 items. It is a four-point Likert-type scale with the options "always, often, sometimes and never".
World Health Organization's Quality of Life (WHOQOL-BREF) Questionnaire
Time frame: Two months
The scale consists of 27 questions in total. This scale, which is completed by the participants, evaluates quality of life from 4 dimensions: physical health domain, psychological domain, social relations domain and environmental domain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Stress Reduction Program in people with Stress, run by Muş Alparslan 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 2 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. 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?
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?
Mindful Attention Awareness Scale (time frame: Two months). The study lists 3 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 7 Jun 2024.