Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-26 @ 5:38 PM
Study NCT ID:
NCT05831293
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2023-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Based Reduction Stress Program
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: