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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)

20 juillet 2026 mis à jour par: Gizem Bilmez, Ufuk University

**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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

This research is planned as a randomized controlled trial to evaluate the effect of a hysterectomy adaptation training program, based on the Roy Adaptation Model, on hysterectomy compliance, self-esteem, and quality of life in women who have undergone hysterectomy. The study aims to assess the effectiveness of the hysterectomy adaptation training program developed based on the Roy Adaptation Model. A G-Power analysis was conducted to determine the sample size. The sample will consist of 110 individuals: 55 in the control group and 55 in the intervention group. The data collection tools used in the research are: "Personal Information Form (PIF), Hysterectomy Adaptation Scale, Rosenberg Self-Esteem Rating Scale (RSR), and World Health Organization Quality of Life Scale (WHOQOL-BREF). Participants will be assigned to the intervention and control groups using a simple randomization method. The intervention group will receive the hysterectomy adaptation training program developed based on the Roy Adaptation Model. The control group will undergo routine follow-ups.

Type d'étude

Interventionnel

Inscription (Estimé)

108

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 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.
Expérimental: 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.
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.
Autres noms:
  • hysterectomy education

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hysterectomy Adaptation
Délai: 8 weeks after training
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.
8 weeks after training
Hysterectomy Adaptation
Délai: Changes in adaptation scores from baseline to 8 weeks after the intervention will be compared between
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

  • 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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 octobre 2026

Achèvement de l'étude (Estimé)

30 novembre 2026

Dates d'inscription aux études

Première soumission

16 juillet 2026

Première soumission répondant aux critères de contrôle qualité

20 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 05/1294

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared because the informed consent obtained from participants does not include permission for public data sharing, and sharing may compromise participant confidentiality.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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