Clinical Trials Directory

Trials / Completed

CompletedNCT06416176

The Effect of a Mindfulness-Based Stress Reduction Program in Patients With Multiple Sclerosis

The Effect of a Mindfulness-Based Stress Reduction Program On Fatigue, Self-Efficacy And Stress in Patients With Multiple Sclerosis: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Halic University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to investigate the effect of an mindfulness-based stress reduction (MBSR) program designed in accordance with the literature and the basic principles of the program on fatigue, self-efficacy and stress for individuals with multiple sclerosis (MS). Thirty members of the Multiple Sclerosis Society with multiple sclerosis were randomized as experimental and control groups. Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Outcome measurements consisted of Fatigue Impact Scale (FIS), Self-Efficacy Scale and Perceived Stress Scale.

Detailed description

The use of mindfulness-based interventions to reduce fatigue in individuals with MS is supported by meta-analytic evidence. A systematic review concluded that mindfulness-based interventions effectively improves the quality of life in MS patients. To characterize the best formatting, mechanisms of action, and outcomes in MS patients with a wider range of social, educational, and clinical backgrounds, more research is necessary. Participants in the experimental group received an 8-week MBSR program by an MBSR instructor. Each meeting were planned as a 3-hour session that completes the mindfulness training procedures by doing an opening meditation of 30- 45 minutes about that week, after the information about the meeting topic of the week is discussed. Experiences after meditation were shared with the group. Each week, the meeting topic and meditation continued with different contents, and practice meditations on the subject were held every week and home exercises were given. Home practice meditations were performed by listening to the guide audio recording with headphones. All home exercises in the training content were followed up on a daily basis and recorded. The patients in the control group continued to visit the society for their scheduled examinations and controls; no intervention was given to them. Furthermore, the control group received an invitation to participate in an identical MBSR program session following the study's conclusion.

Conditions

Interventions

TypeNameDescription
OTHERMindfulness-Based Stress Reduction (MBSR) ProgramParticipants in the experimental group received an 8-week MBSR program by an MBSR instructor. Each meeting were planned as a 3-hour session that completes the mindfulness training procedures by doing an opening meditation of 30- 45 minutes about that week, after the information about the meeting topic of the week is discussed. Experiences after meditation were shared with the group. Each week, the meeting topic and meditation continued with different contents, and practice meditations on the subject were held every week and home exercises were given. Home practice meditations were performed by listening to the guide audio recording with headphones. All home exercises in the training content were followed up on a daily basis and recorded.

Timeline

Start date
2020-07-01
Primary completion
2020-10-01
Completion
2020-11-15
First posted
2024-05-16
Last updated
2024-05-16

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06416176. Inclusion in this directory is not an endorsement.