NCT06449118

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 27, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

Mindfulness Stress Reduction Programphysically disabledparentquality of lifestress

Outcome Measures

Primary Outcomes (3)

  • 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.

    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".

    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.

    Two months

Study Arms (2)

Mindfulness Stress Reduction

ACTIVE COMPARATOR

Mindfulness Stress Reduction Program

Behavioral: Mindfulness Stress Reduction Program

Control

NO INTERVENTION

No intervention

Interventions

Mindfulness based-Stress Reduction Program an 8-week program

Mindfulness Stress Reduction

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being able to read and write
  • Having a child diagnosed with a physical disability

You may not qualify if:

  • Having more than one physically disabled child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 7, 2024

Study Start

June 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

June 7, 2024

Record last verified: 2024-05