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)
July 20, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
108
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No 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.
|
|
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Experimental: 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hysterectomy Adaptation
Time Frame: 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
|
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Hysterectomy Adaptation
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
July 16, 2026
First Submitted That Met QC Criteria
July 20, 2026
First Posted (Actual)
July 23, 2026
Study Record Updates
Last Update Posted (Actual)
July 23, 2026
Last Update Submitted That Met QC Criteria
July 20, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 05/1294
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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