Infertility, Polycystic Ovarian Syndrome (PCOS), Psychological Stress
Conditions
Keywords
PCOS, POLYCYSTIC OVARY SYNDROME, THETA HEALING, SELF-COMPASSION, BODY IMAGE, COMPLEMENTARY THERAPY, MEDITATION, REPRODUCTIVE HEALTH, Women's Health, Mind-Body Intervention, fertility anxiety
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.
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.
Interventions
BEHAVIORALTheta 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.
Sponsors
Ankara Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the behavioral intervention, participants and researchers cannot be blinded.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fertility Anxiety Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Body Self-Compassion Score | 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. |
| Body Image Score | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTTugba Tahta, Assistant Professor
CONTACTSeniha Balci Cebeci, Research Assistant
STUDY_CHAIRSeniha Balci Cebeci, Research Assistant
Ankara Medipol University
STUDY_DIRECTORTugba Tahta, Assistant Professor
Ankara Medipol University
STUDY_CHAIRSinem Ceylan, Assistant Professor
Saglik Bilimleri Universitesi
STUDY_CHAIROzge Aydogan Asir, Assistant Professor
Ankara Medipol University
STUDY_CHAIRGulten Guvenc, Professor
Saglik Bilimleri Universitesi
Outcome results
None listed