Polycystic Ovarian Syndrome (PCOS)NCT07630441
Theta Healing-Based Intervention in Women With Polycystic Ovary Syndrome
A study testing Theta Healing-Based Intervention in people with Polycystic Ovarian Syndrome (PCOS) and Infertility, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of a Theta Healing-based intervention on fertility concerns, self-compassion, and body image in women diagnosed with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to intervention and control groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS), Infertility, Psychological Stress
- What is being tested?
- Theta Healing-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years
- Diagnosed with Polycystic Ovary Syndrome (PCOS)
- Able to read and understand Turkish
- Voluntary participation in the study
- Access to a smartphone and internet connection
Who cannot join
- Diagnosed psychiatric disorder
- Participation in another psychological intervention program
- Any health condition preventing participation in the intervention sessions
- Incomplete questionnaire responses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Medipol University Faculty of Health Sciences
Ankara, 06000
Tugba Tahta, Assistant Professor, +905425085543, tugba.tahta@ankaramedipol.edu.tr
Seniha Balci Cebeci, Research Assistant, +905439132414, senihaabalcii@gmail.com
About this study
Official title: The Effect of a Theta Healing-Based Intervention on Fertility Anxiety, Body Self-Compassion, and Body Image in Women Diagnosed With Polycystic Ovary Syndrome: A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effect of a Theta Healing-based intervention on fertility concerns, self-compassion, and body image in women diagnosed with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to intervention and control groups. The intervention group will receive a structured 5-day Theta Healing-based online intervention program, while the control group will continue routine care. Outcome measures will be assessed at baseline and 6 weeks after the intervention.
Read the detailed description
Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age and is frequently associated with infertility, body image disturbances, anxiety, and psychological stress. Women diagnosed with PCOS often experience fertility-related concerns and impaired self-perception due to symptoms such as menstrual irregularities, hirsutism, acne, and obesity.
Self-compassion is considered a protective psychosocial factor that supports emotional resilience and psychological well-being. Recently, complementary and integrative approaches have gained attention for improving emotional and psychological outcomes in women's health.
Theta Healing is a meditation- and awareness-based complementary approach designed to promote emotional transformation through relaxation, visualization, positive cognitive restructuring, and subconscious belief work.
This randomized controlled trial aims to evaluate the effects of a structured Theta Healing-based intervention on fertility concerns, self-compassion, and body image in women diagnosed with PCOS. Participants will be randomized into intervention and control groups. The intervention group will receive a structured 5-day Theta Healing-based online intervention program including meditation, visualization, relaxation exercises, positive affirmations, subconscious awareness practices, and self-compassion-focused exercises. The control group will continue routine care without additional intervention.
Outcome measures will be collected at baseline and 6 weeks after the intervention using validated scales.
- Being tested
- Theta Healing-Based Intervention
- Keywords
- PCOS, POLYCYSTIC OVARY SYNDROME, THETA HEALING, SELF-COMPASSION, BODY IMAGE, COMPLEMENTARY THERAPY, MEDITATION, REPRODUCTIVE HEALTH, Women's Health, Mind-Body Intervention, fertility anxiety
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta Healing-Based InterventionBehavioural
The intervention consists of a structured 5-day Theta Healing-based online program including guided meditation, relaxation exercises, visualization, positive affirmations, subconscious awareness practices, and self-compassion-focused exercises. Audio recordings will be delivered daily via WhatsApp, and a final online group session will be conducted on the fifth day by a certified Theta Healing practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Theta Healing Intervention Group | Experimental | Participants in this group will receive a structured Theta Healing-based intervention program including guided meditation, subconscious belief transformation, positive cognition development, relaxation exercises, and awareness practices. Receives: Behavioral: Theta Healing-Based Intervention |
| Control Group | No intervention | Participants in this group will not receive any intervention and will continue their usual daily routines throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility Anxiety Score
Fertility anxiety will be assessed using the Fertility Anxiety Questionnaire (FAQ), a researcher-developed questionnaire created based on an extensive literature review and expert consultation. The instrument consists of 12 items organized into three domains: Future-Oriented Concerns (Items 1-4), Social Pressure and Expectations (Items 5-8), and Information and Support Seeking (Items 9-12). Each item is rated on a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). Total scores range from 0 to 48, with higher scores indicating greater fertility-related anxiety and concern regarding reproductive potential and future childbearing.
Measured: Baseline and 6 weeks after intervention
Secondary outcomes (2)
Body Self-Compassion Score
Body self-compassion will be assessed using the Body Self-Compassion Scale (BSCS), which was culturally adapted and validated for the Turkish population. The scale consists of 21 items rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 21 to 105, with higher scores indicating greater body-related self-compassion. The scale evaluates three dimensions: Isolation, Body Acceptance, and Common Humanity. The reported Cronbach's alpha coefficient for the total scale is 0.89.
Measured: Baseline and 6 weeks after intervention
Body Image Score
Body image will be assessed using the Body Image Scale (BIS), a multidimensional instrument developed to evaluate body image perceptions among adolescents and young adults. The scale consists of 21 items rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Total scores range from 21 to 105. Higher scores indicate a more negative body image perception. The scale includes four dimensions: Negative Body Perception, Evaluation Sensitivity, Positive Body Perception, and Body Change. Several items are reverse-coded according to the scoring guidelines.
Measured: Baseline and 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start8 Jun 2026 (estimated)
- Primary completion24 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- 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
- This study is a two-arm, parallel-group, randomized controlled intervention trial. Women diagnosed with Polycystic Ovary Syndrome (PCOS) who meet the inclusion criteria will be randomly assigned to the intervention and control groups at a 1:1 ratio. The intervention group will receive structured sessions based on the Theta Healing technique. These sessions will include guided meditation, identification and transformation of subconscious beliefs, and the development of positive cognitions. No intervention will be applied to the control group, and participants will continue their usual daily routines. Data will be collected at two time points, before and after the intervention, and levels of fertility concern, self-compassion, and body image will be evaluated. The effectiveness of the intervention will be analyzed through comparisons between the groups.
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SENİHA BALCI CEBECİ, Ankara Medipol University
- Investigators
- Seniha Balci Cebeci, Research Assistant, Study chair, Ankara Medipol UniversityTugba Tahta, Assistant Professor, Study director, Ankara Medipol UniversitySinem Ceylan, Assistant Professor, Study chair, Saglik Bilimleri UniversitesiOzge Aydogan Asir, Assistant Professor, Study chair, Ankara Medipol UniversityGulten Guvenc, Professor, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630441
- Sponsor's protocol ID
- E-85859696-604.01.01-12092
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be publicly shared to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Theta Healing-Based Intervention on Fertility Anxiety, Body Self-Compassion, and Body Image in Women Diagnosed With Polycystic Ovary Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07630441
- Acronym / sponsor ID
- E-85859696-604.01.01-12092
- Keywords
- PCOS, POLYCYSTIC OVARY SYNDROME, THETA HEALING, SELF-COMPASSION, BODY IMAGE, COMPLEMENTARY THERAPY, MEDITATION, REPRODUCTIVE HEALTH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 5 Jun 2026 (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.
This randomized controlled study aims to evaluate the effect of a Theta Healing-based intervention on fertility concerns, self-compassion, and body image in women diagnosed with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to intervention and control groups. The intervention group will receive a structured 5-day Theta Healing-based online intervention program, while the control group will continue routine care. Outcome measures will be assessed at baseline and 6 weeks after the intervention.
Detailed description
Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders affecting women of reproductive age and is frequently associated with infertility, body image disturbances, anxiety, and psychological stress. Women diagnosed with PCOS often experience fertility-related concerns and impaired self-perception due to symptoms such as menstrual irregularities, hirsutism, acne, and obesity.
Self-compassion is considered a protective psychosocial factor that supports emotional resilience and psychological well-being. Recently, complementary and integrative approaches have gained attention for improving emotional and psychological outcomes in women's health.
Theta Healing is a meditation- and awareness-based complementary approach designed to promote emotional transformation through relaxation, visualization, positive cognitive restructuring, and subconscious belief work.
This randomized controlled trial aims to evaluate the effects of a structured Theta Healing-based intervention on fertility concerns, self-compassion, and body image in women diagnosed with PCOS. Participants will be randomized into intervention and control groups. The intervention group will receive a structured 5-day Theta Healing-based online intervention program including meditation, visualization, relaxation exercises, positive affirmations, subconscious awareness practices, and self-compassion-focused exercises. The control group will continue routine care without additional intervention.
Outcome measures will be collected at baseline and 6 weeks after the intervention using validated scales.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a two-arm, parallel-group, randomized controlled intervention trial. Women diagnosed with Polycystic Ovary Syndrome (PCOS) who meet the inclusion criteria will be randomly assigned to the intervention and control groups at a 1:1 ratio. The intervention group will receive structured sessions based on the Theta Healing technique. These sessions will include guided meditation, identification and transformation of subconscious beliefs, and the development of positive cognitions. No intervention will be applied to the control group, and participants will continue their usual daily routines. Data will be collected at two time points, before and after the intervention, and levels of fertility concern, self-compassion, and body image will be evaluated. The effectiveness of the intervention will be analyzed through comparisons between the groups.
| Arm | Type | Receives |
|---|---|---|
| Theta Healing Intervention Group | Experimental | Behavioral: Theta Healing-Based InterventionParticipants in this group will receive a structured Theta Healing-based intervention program including guided meditation, subconscious belief transformation, positive cognition development, relaxation exercises, and awareness practices. |
| Control Group | No intervention | –Participants in this group will not receive any intervention and will continue their usual daily routines throughout the study period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-45 years
- Diagnosed with Polycystic Ovary Syndrome (PCOS)
- Able to read and understand Turkish
- Voluntary participation in the study
- Access to a smartphone and internet connection
Key exclusion criteria (4 listed)
- Diagnosed psychiatric disorder
- Participation in another psychological intervention program
- Any health condition preventing participation in the intervention sessions
- Incomplete questionnaire responses
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 |
|---|---|---|
| Theta Healing-Based InterventionThe intervention consists of a structured 5-day Theta Healing-based online program including guided meditation, relaxation exercises, visualization, positive affirmations, subconscious awareness practices, and self-compassion-focused exercises. Audio recordings will be delivered daily via WhatsApp, and a final online group session will be conducted on the fifth day by a certified Theta Healing practitioner. | Behavioural | Theta Healing Intervention Group |
Primary outcome
Fertility Anxiety Score
Time frame: Baseline and 6 weeks after intervention
Fertility anxiety will be assessed using the Fertility Anxiety Questionnaire (FAQ), a researcher-developed questionnaire created based on an extensive literature review and expert consultation. The instrument consists of 12 items organized into three domains: Future-Oriented Concerns (Items 1-4), Social Pressure and Expectations (Items 5-8), and Information and Support Seeking (Items 9-12). Each item is rated on a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). Total scores range from 0 to 48, with higher scores indicating greater fertility-related anxiety and concern regarding reproductive potential and future childbearing.
2 secondary outcomes
Body Self-Compassion Score
Time frame: Baseline and 6 weeks after intervention
Body Image Score
Time frame: Baseline and 6 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No. Data will not be publicly shared to protect participant confidentiality and privacy.
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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.
Seniha Balci Cebeci, Research Assistant study chair
Ankara Medipol University
Tugba Tahta, Assistant Professor study director
Ankara Medipol University
Sinem Ceylan, Assistant Professor study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta Healing-Based Intervention in people with Polycystic Ovarian Syndrome (PCOS) and Infertility, run by Ankara Medipol 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 5 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: opening soon, as of the sponsor's last update on 5 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugba Tahta, Assistant Professor (+905425085543, tugba.tahta@ankaramedipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility Anxiety Score (time frame: Baseline and 6 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.