Theta Healing-Based Intervention in Women With Polycystic Ovary Syndrome

June 3, 2026 updated by: SENİHA BALCI CEBECİ, Ankara Medipol University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diagnosed psychiatric disorder
  • Participation in another psychological intervention program
  • Any health condition preventing participation in the intervention sessions
  • Incomplete questionnaire responses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Theta Healing Intervention Group
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.
Behavioral: Theta Healing-Based Intervention
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.
No Intervention: Control Group
Participants in this group will not receive any intervention and will continue their usual daily routines throughout the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Self-Compassion Score
Time Frame: Baseline and 6 weeks after intervention
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.
Baseline and 6 weeks after intervention
Body Image Score
Time Frame: Baseline and 6 weeks after intervention
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.
Baseline and 6 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Medipol University

Investigators

  • Study Chair: Seniha Balci Cebeci, Research Assistant, Ankara Medipol University
  • Study Director: Tugba Tahta, Assistant Professor, Ankara Medipol University
  • Study Chair: Sinem Ceylan, Assistant Professor, Saglik Bilimleri Universitesi
  • Study Chair: Ozge Aydogan Asir, Assistant Professor, Ankara Medipol University
  • Study Chair: Gulten Guvenc, Professor, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 8, 2026

Primary Completion (Estimated)

July 24, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-85859696-604.01.01-12092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be publicly shared to protect participant confidentiality and privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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