NCT07721727

Brief Summary

\*\*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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 16, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

hysterektomylife qualitywomen healthadaptation

Outcome Measures

Primary Outcomes (2)

  • Hysterectomy Adaptation

    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

    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

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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.

Other: Hysterectomy Adaptation Education

Interventions

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.

Also known as: hysterectomy education
Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women are eligible because the study evaluates the effects of a hysterectomy adaptation education program in women who have undergone hysterectomy. The intervention and outcome measures are specifically designed for this population
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not feasible because participants and the researcher delivering the Roy Adaptation Model-based education program were aware of the group assignments. Therefore, this study was conducted as an open-label randomized controlled trial.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a simple randomization method. The intervention group will receive a Roy Adaptation Model-based hysterectomy adaptation education program in addition to routine care, whereas the control group will receive routine postoperative care only. Outcomes, including hysterectomy adaptation, self-esteem, and quality of life, will be assessed at baseline before the intervention and 8 weeks after the intervention. The effectiveness of the education program will be determined by comparing changes in outcomes between the two parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.