NCT05831293

Mindfulness-Based Reduction Stress Program

The Effect of Mindfulness Based Stress Reduction Program on Stress and Quality of Life in Family Caregivers of Patients With Cancer: Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The participants consisted of 1332 caregivers of patients diagnosed with cancer, who applied to Atatürk University Health Research and Application Center, Outpatient Chemotherapy Unit between December 2022 and March 2023. In the power analysis, the sample of the research; According to Cohen, a total of 108 people, 54 of whom were in the experimental group and 54 in the control group, with a medium effect size of 0.5%, an error margin of 0.05% and a confidence interval of 0.95%, were 95% representative of the universe. Against the possibility of data loss, 20% backup sample was included in this number and the study was planned with a total of 124 people, 62 in the experimental group and 62 in the control group. 20 participants were excluded on the basis of inclusion and exclusion criteria. 104 participants formed the sample

Detailed description

Pretest measurements (T1) were made to the individuals in the experimental and control groups. 8-week mindfulness-based interventions were administered online to caregivers of cancer patients (Table 1). Before starting the MDI program in the experimental group, visual and written materials about the sessions prepared by the researchers were distributed. The program was implemented 4 days a week, 1 session a day, and each session was implemented in groups of 10-15 people for 60-90 minutes. After the 8-week MDI Program of the experimental group was completed, the data collection forms were re-applied to the individuals in the experimental and control groups, and posttest-1 measurements (T2) were made. 4 weeks after the posttest-1 measurements, the posttest-2 measurements (T3) of the individuals in the experimental and control groups were performed.

Conditions

• Cancer
• Caregiver Stress
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Based Stress Reduction Program	In each session, three sections were discussed and reviewed: (1) last week's experiences, (2) training, and (3) practice. Each session usually began with mindfulness and meditation exercises, followed by group discussion, review of homework activities, and introduction to new exercises. Participants were asked to complete 15-30 minutes of daily practice each week.

Timeline

• Start date: 2023-01-15
• Primary completion: 2023-03-15
• Completion: 2023-09-15
• First posted: 2023-04-26
• Last updated: 2023-11-02

Locations

2 sites across 1 country: Turkey (Türkiye)