The Effect of Mindfulness-based Yoga and Meditation on Some Parameters in Breast Cancer Patients

NCT ID: NCT06110832

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-11
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this study was to evaluate the effect of mindfulness-based meditation and yoga on stress, self-esteem, body image and sexual adjustment in breast cancer patients.

Detailed Description

The study was conducted in a single-center, prospective (pretest-posttest-2. month follow-up), two-arm (1:1), randomized controlled experimental design.

In this study, the effects of an 8-week structured mindfulness-based meditation and yoga program on stress, self-esteem, body image and sexual adjustment will be evaluated in women undergoing modified radical mastectomy. The 8-week interventions were conducted by the researcher. The researcher who performed these applications has a certificate of mindfulness meditation, yoga, breathing and movement trainer. Due to the nature of the research, the researcher is involved in the implementation of the mindfulness-based meditation and yoga program, data collection and data entry into the system. At the same time, the women in the experimental group had to be informed about the research. Therefore, researcher and participant blinding could not be performed. However, randomization was performed to prevent selection bias (1:1). The randomization process was performed by a statistical expert other than the researcher and communicated to the researcher. The participants included in the study were numbered from 1 to 41, preserving their random order in the list received from the hospital. The groups were divided into Group 1 and Group 2 by the statistician and the first group was determined as the experimental group and the second group as the control group by lottery method. The randomization table was created by making use of "http://calculatorsoup.com". Before the 8-week process started, 3 measurements were made to the participants: pre-test, post-test at the end of 8 weeks and follow-up measurement 2 months after the application.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-based Meditation and Yoga Intervention Group

After randomization, participants in the experimental group underwent mindfulness-based meditation and yoga practices with 90-minute sessions on Thursdays for 8 weeks. In these practices, a different theme was determined each week.

The 8-week theme headings are as follows:

Week 1 exploring mindfulness Week 2: How do we perceive the world? week 3 being in the body Week 4 meeting stress with mindful awareness Week 5 our relationship with stress-inducing thoughts Week 6 Communication with mindfulness Week 7 taking care of yourself Week 8 farewell and a new beginning

Group Type: EXPERIMENTAL

Mindfulness-based Meditation and Yoga program

Intervention Type: BEHAVIORAL

In the mindfulness-based meditation and yoga program, mindfulness-based formal and informal interventions are conducted for 8 weeks.

Control Group

No intervention was applied to the control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-based Meditation and Yoga program

In the mindfulness-based meditation and yoga program, mindfulness-based formal and informal interventions are conducted for 8 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Able to read and write Turkish,
• Who have undergone modified radical mastectomy surgery,
• Female patients between the ages of 30-55,
• Premenopausal patients,
• At least 3 months have passed since the mastectomy operation and all available treatments (chemotherapy and/or radiotherapy treatments),
• No condition that constitutes an obstacle for active sexual life (for sexual compatibility assessment),
• Those who have not undergone plastic and reconstructive surgery for the breast after modified radical mastectomy,
• Those who have no previous meditation and/or yoga experience,
• Those who do not have a diagnosis of a mental disorder of organic origin,
• Those who do not have substance and/or alcohol addiction,
• Those who do not have severe depression accompanying the disease,
• Those who do not have a physical disability that would prevent participation in the study,
• Those who agree to participate in the study will be included in the sample.

Exclusion Criteria

• Patients who received neoadjuvant chemotherapy in the preoperative period,
• Patients under the age of 30 and over the age of 55,
• Patients who have undergone oncoplastic, breast-conserving surgery,
• Patients with previous experience of mindfulness, meditation or yoga will not be included in the study.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Koç University

OTHER

Sponsor Role: collaborator

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Melike Pehlivan

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melike Pehlivan

Role: PRINCIPAL_INVESTIGATOR

Kutahya Health Science University

Semra Eyi

Role: STUDY_DIRECTOR

Osmangazi University

Locations

Kutahya Health Science University

Kütahya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Pehlivan M, Eyi S. The Impact of Mindfulness-Based Meditation and Yoga on Stress, Body Image, Self-esteem, and Sexual Adjustment in Breast Cancer Patients Undergoing Modified Radical Mastectomy: A Randomized Controlled Trial. Cancer Nurs. 2025 May-Jun 01;48(3):190-199. doi: 10.1097/NCC.0000000000001427. Epub 2024 Nov 18.

Reference Type: DERIVED

PMID: 39773822 (View on PubMed)

Other Identifiers

KHSU-GSHMYO-MP-01

Identifier Type: -

Identifier Source: org_study_id