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

K

Kutahya Health Sciences University

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: Mindfulness-based Meditation and Yoga program

Study type

Interventional

Funder types

Other

Identifiers

NCT06110832
KHSU-GSHMYO-MP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

Female

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

41 participants in 2 patient groups

Mindfulness-based Meditation and Yoga Intervention Group
Experimental group
Description:
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
Treatment:
Behavioral: Mindfulness-based Meditation and Yoga program
Control Group
No Intervention group
Description:
No intervention was applied to the control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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