- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07721727
Evaluation of the Effects of a Hysterectomy Adherence Education Program Based on the Roy Adaptation Model on Hysterectomy Adherence, Self-Esteem, and Quality of Life in Women Undergoing Hysterectomy (HYSTADAPT)
**Brief Summary**
This randomized controlled trial aims to evaluate the effectiveness of a Roy Adaptation Model-based hysterectomy adaptation education program on adaptation to hysterectomy, self-esteem, and quality of life in women who have undergone hysterectomy. A total of 110 participants will be randomly assigned to either the intervention group (n = 55) or the control group (n = 55). The intervention group will receive the Roy Adaptation Model-based education program, while the control group will receive routine care. Outcomes will be assessed using the Hysterectomy Adaptation Scale, Rosenberg Self-Esteem Rating Scale, and WHOQOL-BREF. The study will determine whether the education program improves adaptation, self-esteem, and quality of life compared with routine care.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Women who have completed at least primary school education. Premenopausal women who have undergone hysterectomy. Have access to the internet and possess a device (smartphone, tablet, or computer) capable of participating in online education sessions.
Have an adequate level of health literacy to understand the educational materials, access online information, and follow the intervention.
Be sexually active.
Exclusion Criteria:
- Diagnosed with a sleep disorder. Have a physical and/or mental disability. Have communication difficulties (e.g., speech, language, comprehension, or cognitive impairment).
Have a diagnosis of cancer. Currently receiving hormone therapy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Control Group
Participants assigned to the control group will receive routine postoperative care and follow-up according to the hospital's standard clinical practice.
They will not receive the Roy Adaptation Model-based hysterectomy adaptation education program during the study period.
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Eksperimentel: Intervention Group
Participants assigned to the intervention group will receive a Roy Adaptation Model-based hysterectomy adaptation education program in addition to routine postoperative care.
The education program is designed to enhance adaptation to hysterectomy by addressing physiological, self-concept, role function, and interdependence adaptation, consistent with the Roy Adaptation Model.
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The intervention is a structured education program developed according to the Roy Adaptation Model for women who have undergone hysterectomy.
It includes education on postoperative physical recovery, symptom management, self-concept, role function, interpersonal relationships, coping strategies, and adaptation to life after hysterectomy.
The program is delivered by the researcher using standardized educational materials in addition to routine postoperative care.
Its purpose is to improve adaptation to hysterectomy, increase self-esteem, and enhance quality of life.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hysterectomy Adaptation
Tidsramme: 8 weeks after training
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Adaptation to hysterectomy will be assessed using the Hysterectomy Adaptation Scale.
Higher scores indicate better adaptation to life after hysterectomy.
Changes in adaptation scores from baseline to 8 weeks after the intervention will be compared between the intervention and control groups.
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8 weeks after training
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Hysterectomy Adaptation
Tidsramme: Changes in adaptation scores from baseline to 8 weeks after the intervention will be compared between
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Adaptation to hysterectomy will be assessed using the Hysterectomy Adaptation Scale.
Higher scores indicate better adaptation to life after hysterectomy.
|
Changes in adaptation scores from baseline to 8 weeks after the intervention will be compared between
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Alshawish, Eman, Miss Shurouq Qadous, and Miss Ala'a Yamani. 2020. "Experience of Palestinian Women After Hysterectomy Using a Descriptive Phenomenological Study." The Open Nursing Journal 14(1): 74-79. doi:10.2174/1874434602014010074. Burma, Ebru, and Oya Kavlak. 2021. "Histerektomi Ameliyatı Geçiren Kadınlarda Kaygı , Ağrı ve Sosyal Desteğin Derlenme Kalitesine Etkisi The Effect of Anxiety , Pain and Social Support on Recovery Quality in Women Undergoing Hysterectomy." 10(3): 325-33. Desai, Sapna, Oona M.R. Campbell, Tara Sinha, Ajay Mahal, and Simon Cousens. 2017. "Incidence and Determinants of Hysterectomy in a Low-Income Setting in Gujarat, India." Health Policy and Planning 32(1): 68-78. doi:10.1093/heapol/czw099. Erdoğan, Esra, Satı Demir, Behice Belkıs Çalışkan, and Nurten Gülsüm Bayrak. 2020. "Effect of Psychological Care given to the Women Who Underwent Hysterectomy before and after the Surgery on Depressive Symptoms, Anxiety and the Body Image Levels*." Journal of Obstetrics and Gynaecology 40(7): 981-87. doi:10.1080/01443615.2019.1678574. Fawcett, Jacqueline. 2005. Contemporary Nursing Knowledge : Analysis and Evaluation of Nursing Models and Theories. Davıs Company. Gökçe, Elmas. 2024. "HİSTEREKTOMİ AMELİYATI OLMUŞ KADINLARDA BEDEN ALGISI İLE CİNSEL DOYUM ARASINDAKİ İLİŞKİSİNİN İNCELENMESİ." İstanbul Arel Üniversitesi. file:///C:/Users/NEW/Downloads/858549 (1).pdf. Goudarzi, Fatemeh, Raheleh Babazadeh, Abbas Ebadi, and Talat Khadivzadeh. 2024. "Adaptation to Hysterectomy: Design and Psychometric Properties Assessment of Hysterectomy Adaptation Scale." Iranian Journal of Nursing and Midwifery Research 29(4): 479-85. doi:10.4103/ijnmr.ijnmr_217_21.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 05/1294
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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