- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06449118
Effectiveness of Mindfulness-based Stress Reduction Program
June 6, 2024 updated by: Muş Alparlan University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being able to read and write
- Having a child diagnosed with a physical disability
Exclusion Criteria:
- Having more than one physically disabled child
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
|
|
|
Active Comparator: Mindfulness Stress Reduction
Mindfulness Stress Reduction Program
|
Mindfulness based-Stress Reduction Program an 8-week program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Two months
|
|
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".
|
Two months
|
|
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.
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
May 27, 2024
First Submitted That Met QC Criteria
June 6, 2024
First Posted (Actual)
June 7, 2024
Study Record Updates
Last Update Posted (Actual)
June 7, 2024
Last Update Submitted That Met QC Criteria
June 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- c.taskaya
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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