- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07630441
Theta Healing-Based Intervention in Women With Polycystic Ovary Syndrome
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tugba Tahta, Assistant Professor
- 전화번호: +905425085543
- 이메일: tugba.tahta@ankaramedipol.edu.tr
연구 연락처 백업
- 이름: SENİHA BALCI CEBECİ, Research Assistant
- 전화번호: +905439132414
- 이메일: senihaabalcii@gmail.com
연구 장소
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Ankara, 터키 (Türkiye), 06000
- Ankara Medipol University Faculty of Health Sciences
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연락하다:
- Tugba Tahta, Assistant Professor
- 전화번호: +905425085543
- 이메일: tugba.tahta@ankaramedipol.edu.tr
-
연락하다:
- SENİHA BALCI CEBECİ, Research Assistant
- 전화번호: +905439132414
- 이메일: senihaabalcii@gmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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간섭 없음: Control Group
Participants in this group will not receive any intervention and will continue their usual daily routines throughout the study period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fertility Anxiety Score
기간: Baseline and 6 weeks after intervention
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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.
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Baseline and 6 weeks after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body Self-Compassion Score
기간: Baseline and 6 weeks after intervention
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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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Baseline and 6 weeks after intervention
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Body Image Score
기간: Baseline and 6 weeks after intervention
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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.
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Baseline and 6 weeks after intervention
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공동 작업자 및 조사자
수사관
- 연구 의자: Seniha Balci Cebeci, Research Assistant, Ankara Medipol University
- 연구 책임자: Tugba Tahta, Assistant Professor, Ankara Medipol University
- 연구 의자: Sinem Ceylan, Assistant Professor, Saglik Bilimleri Universitesi
- 연구 의자: Ozge Aydogan Asir, Assistant Professor, Ankara Medipol University
- 연구 의자: Gulten Guvenc, Professor, Saglik Bilimleri Universitesi
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- E-85859696-604.01.01-12092
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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