Theta Healing-Based Intervention in Women With Polycystic Ovary Syndrome

NCT07630441 | Not Yet Recruiting

• 1 other identifier: E-85859696-604.01.01-12092
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility; Polycystic Ovarian Syndrome (PCOS); Psychological Stress

Keywords

PCOS; POLYCYSTIC OVARY SYNDROME; THETA HEALING; SELF-COMPASSION; BODY IMAGE; COMPLEMENTARY THERAPY; MEDITATION; REPRODUCTIVE HEALTH; Women's Health; Mind-Body Intervention; fertility anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 weeks after intervention

Secondary Outcomes (2)

• Body Self-Compassion Score

  Baseline and 6 weeks after intervention

• Body Image Score

  Baseline and 6 weeks after intervention

Study Arms (2)

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.

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.

Interventions

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.

Theta Healing Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Medipol University: lead

Study Sites (1)

Ankara Medipol University Faculty of Health Sciences

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Stress, Psychological

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Seniha Balci Cebeci, Research Assistant

  Ankara Medipol University

  STUDY CHAIR

• Tugba Tahta, Assistant Professor

  Ankara Medipol University

  STUDY DIRECTOR

• 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 CHAIR

Central Study Contacts

Tugba Tahta, Assistant Professor

CONTACT

+905425085543; tugba.tahta@ankaramedipol.edu.tr

Seniha Balci Cebeci, Research Assistant

CONTACT

+905439132414; senihaabalcii@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the behavioral intervention, participants and researchers cannot be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 5, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)