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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Group | No Intervention | Participants in this group will not receive any intervention and will continue their usual daily routines throughout the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tugba Tahta, Assistant Professor | Contact | +905425085543 | tugba.tahta@ankaramedipol.edu.tr | |
| Seniha Balci Cebeci, Research Assistant | Contact | +905439132414 | senihaabalcii@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seniha Balci Cebeci, Research Assistant | Ankara Medipol University | Study Chair |
| Tugba Tahta, Assistant Professor | Ankara Medipol University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Medipol University Faculty of Health Sciences | Ankara | 06000 | Turkey (Türkiye) |
Data will not be publicly shared to protect participant confidentiality and privacy.
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007246 | Infertility |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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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.
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Due to the nature of the behavioral intervention, participants and researchers cannot be blinded.
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| 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. | Baseline and 6 weeks after intervention |
| 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 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |