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

NCT06110832 | Completed

• 1 other identifier: KHSU-GSHMYO-MP-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stress; body image; self esteem; sexual desire

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale

  The Perceived Stress Scale developed by Cohen, Kamarck and Mermelstein (1983) consists of 14 items and has 2 sub-dimensions (perception of inadequate self-efficacy and perception of stress/discomfort). Individuals are asked to rate on a 5-point Likert scale how often they have experienced certain feelings or thoughts in the last month.

  Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)

Secondary Outcomes (3)

• Rosenberg Self-Esteem Scale

  Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)

• Sexual Compliance and Body Image Scale

  Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)

• Female Sexual Function Scale

  Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)

Study Arms (2)

Mindfulness-based Meditation and Yoga Intervention Group

EXPERIMENTAL

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

Behavioral: Mindfulness-based Meditation and Yoga program

Control Group

NO INTERVENTION

No intervention was applied to the control group

Interventions

Mindfulness-based Meditation and Yoga program BEHAVIORAL

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

Mindfulness-based Meditation and Yoga Intervention Group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead
• Koç University: collaborator

Study Sites (1)

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39773822 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Melike Pehlivan

  Kutahya Health Science University

  PRINCIPAL INVESTIGATOR

• Semra Eyi

  Osmangazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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. The data obtained from the research were coded as Group 1 and Group 2 by the researcher and transferred to the analysis program. The statistical expert who performed the analysis had no knowledge about the groups. Thus, it was aimed to control statistical bias, control bias and detection bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 2-arm study with experimental control groups

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: May 11, 2023
• Primary Completion: August 25, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)