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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tugba Tahta, Assistant Professor
- 電話番号：+905425085543
- メール：tugba.tahta@ankaramedipol.edu.tr
研究連絡先のバックアップ
- 名前：SENİHA BALCI CEBECİ, Research Assistant
- 電話番号：+905439132414
- メール：senihaabalcii@gmail.com
研究場所
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Ankara、トルコ（Türkiye）、06000
- Ankara Medipol University Faculty of Health Sciences
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コンタクト：
- Tugba Tahta, Assistant Professor
- 電話番号：+905425085543
- メール：tugba.tahta@ankaramedipol.edu.tr
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コンタクト：
- SENİHA BALCI CEBECİ, Research Assistant
- 電話番号：+905439132414
- メール：senihaabalcii@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fertility Anxiety Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body Self-Compassion Score
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Seniha Balci Cebeci, Research Assistant、Ankara Medipol University
- スタディディレクター：Tugba Tahta, Assistant Professor、Ankara Medipol University
- スタディチェア：Sinem Ceylan, Assistant Professor、Saglik Bilimleri Universitesi
- スタディチェア：Ozge Aydogan Asir, Assistant Professor、Ankara Medipol University
- スタディチェア：Gulten Guvenc, Professor、Saglik Bilimleri Universitesi
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- E-85859696-604.01.01-12092
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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