Breast CancerNCT06110832
The Effect of Mindfulness-based Yoga and Meditation on Some Parameters in Breast Cancer Patients
A study testing Mindfulness-based Meditation and Yoga program in people with Breast Cancer, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mindfulness-based Meditation and Yoga program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Mindfulness-based Meditation and Yoga program
- Keywords
- stress, body image, self esteem, sexual desire
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Meditation and Yoga programBehavioural
In the mindfulness-based meditation and yoga program, mindfulness-based formal and informal interventions are conducted for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Mindfulness-based Meditation and Yoga program |
| Control Group | No intervention | No intervention was applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start11 May 2023
- Primary completion25 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm study with experimental control groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, Melike Pehlivan, Kutahya Health Sciences University
- Investigators
- Melike Pehlivan, Principal investigator, Kutahya Health Science UniversitySemra Eyi, Study director, Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110832
- Sponsor's protocol ID
- KHSU-GSHMYO-MP-01
- Status last verified
- Feb 2024
- First submitted
- 23 Oct 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39773822
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06110832
- Acronym / sponsor ID
- KHSU-GSHMYO-MP-01
- Conditions
- Breast Cancer
- Keywords
- stress, body image, self esteem, sexual desire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 11 May 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm study with experimental control groups
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Meditation and Yoga Intervention Group | Experimental | Behavioral: Mindfulness-based Meditation and Yoga programAfter 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 |
| Control Group | No intervention | –No intervention was applied to the control group |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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),
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Meditation and Yoga programIn the mindfulness-based meditation and yoga program, mindfulness-based formal and informal interventions are conducted for 8 weeks. | Behavioural | Mindfulness-based Meditation and Yoga Intervention Group |
Primary outcome
Perceived Stress Scale
Time frame: Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
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.
3 secondary outcomes
Rosenberg Self-Esteem Scale
Time frame: Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
Sexual Compliance and Body Image Scale
Time frame: Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
Female Sexual Function Scale
Time frame: Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 39773822Pehlivan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melike Pehlivan principal investigator
Kutahya Health Science University
Semra Eyi study director
Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Meditation and Yoga program in people with Breast Cancer, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Week 1 (pre-test), Week 8 (final test) and 2nd month (follow-up measurement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.