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

The Effect of Mindfulness-based Yoga and Meditation Practices on Stress, Self-esteem, Body Image and Sexual Adjustment in Breast Cancer Patients Undergoing Modified Radical Mastectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Mindfulness-based Meditation and Yoga program

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kütahya, Turkey
    • Kutahya Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
No Intervention: Control Group; No intervention was applied to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rosenberg Self-Esteem Scale	Rosenberg Self-Esteem Scale is a self-report scale consisting of 63 multiple-choice questions. The scale consists of twelve subcategories. Rosenberg stated that the subscales can be used separately in research if desired. For the purpose of the study, the first '10' items of the scale will be used to measure self-esteem.	Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
Sexual Compliance and Body Image Scale	The scale was developed by Dalton et al. to assess body image and sexuality in postoperative women with breast cancer. It consists of two separate scales, the Body Image Scale and the Sexual Adjustment Scale. The six-item Body Image Scale has two subscales, namely before body image score and after body image score. These subscales measure body image before and after breast cancer diagnosis. The eight-item Sexual Adjustment Scale has three subscales: sexual adjustment, sexual functioning and sexual importance of breasts score.	Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
Female Sexual Function Scale	It is a personal tool for measuring sexual function that has been validated in women who have been clinically diagnosed with female sexual dysfunction. The Female Sexual Function Scale was developed by Rosen et al. in the USA in 2000 as a 19-item multidimensional scale to assess female sexual function.	Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Collaborators: Koç University
• Investigators: Principal Investigator: Melike Pehlivan, Kutahya Health Science University; Study Director: Semra Eyi, Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: stress; self esteem; body image; sexual desire
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KHSU-GSHMYO-MP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No