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Theta Healing-Based Intervention in Women With Polycystic Ovary Syndrome

3. juni 2026 opdateret af: SENİHA BALCI CEBECİ, Ankara Medipol University

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

142

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Theta 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.
Ingen indgriben: Control Group
Participants in this group will not receive any intervention and will continue their usual daily routines throughout the study period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fertility Anxiety Score
Tidsramme: 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.
Baseline and 6 weeks after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Self-Compassion Score
Tidsramme: 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.
Baseline and 6 weeks after intervention
Body Image Score
Tidsramme: 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.
Baseline and 6 weeks after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ankara Medipol University

Efterforskere

  • Studiestol: Seniha Balci Cebeci, Research Assistant, Ankara Medipol University
  • Studieleder: Tugba Tahta, Assistant Professor, Ankara Medipol University
  • Studiestol: Sinem Ceylan, Assistant Professor, Saglik Bilimleri Universitesi
  • Studiestol: Ozge Aydogan Asir, Assistant Professor, Ankara Medipol University
  • Studiestol: Gulten Guvenc, Professor, Saglik Bilimleri Universitesi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

8. juni 2026

Primær færdiggørelse (Anslået)

24. juli 2026

Studieafslutning (Anslået)

15. september 2026

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E-85859696-604.01.01-12092

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Data will not be publicly shared to protect participant confidentiality and privacy.

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