Mindfulness-Based Reduction Stress Program

NCT05831293 | Completed

• 1 other identifier: nihann
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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

Conditions

Cancer; Caregiver Stress; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Caregiver Stress Scale

  The scale was developed by Robinson (1983) to measure the subjective care burden of caregivers and to quickly identify families with care concerns. Its Turkish adaptation was made by Uğur and Fadıloğlu (2006). The reliability coefficient of the scale was found to be 0.77. The scale consists of 13 items. The scoring of the scale is between 0-1. A score above 7 indicates the burden of care subjectively.

  two week

• The Caregiver Quality of Life Index Cancer Scale -CQOLC

  It was developed by Weitzner et al. to measure the quality of life of caregivers of cancer patients, including physical function, emotional function, family function, and social function. The total score of each sub-dimension and scale in the scale varies between 0 and 140. A higher score indicates a better quality of life.

  Two week

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Stress Reduction Program

Control

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Mindfulness Based Stress Reduction Program BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No psychiatric problems,
• Over 18,
• literate,
• Having internet access at home,
• Not receiving or planning to receive therapy support during the education process,
• Not having any previous mindfulness experience

You may not qualify if:

• Those who want to leave the study,
• Do not accept to participate in the research
• not at a level to answer the questions asked cognitively.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Ataturk Unıversity

Erzurum, 25240, Turkey (Türkiye)

Location

Ataturk Unıversity

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Nihan Türkoğlu, Assist.Prof.

  Ataturk University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: January 15, 2023
• Primary Completion: March 15, 2023
• Study Completion: September 15, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)