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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other: Hysterectomy Adaptation Education
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:
  • hysterectomy education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ufuk University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara Yildirim Beyazıt University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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