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NCT Number: NCT07630441

Theta Healing-Based Intervention in Women With Polycystic Ovary Syndrome

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.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Behavior Behavioral Symptoms Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Psychological Stress Stress, Psychological Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theta Healing-Based Intervention

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Seniha Balci Cebeci, Research Assistant

CONTACT

[email protected]

+905439132414

Tugba Tahta, Assistant Professor

CONTACT

[email protected]

+905425085543

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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