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HysterectomyHYSTADAPTNCT07721727

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

A study testing Hysterectomy Adaptation Education in people with Hysterectomy and Women, run by Ufuk University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Hysterectomy, Women
What is being tested?
Hysterectomy Adaptation Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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.

Read the 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.

Conditions
Hysterectomy, Women
Being tested
Hysterectomy Adaptation Education
Keywords
hysterektomy, life quality, women health, adaptation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hysterectomy Adaptation EducationOther

    Also called hysterectomy 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.

Study groups in NCT07721727
Study groupRoleWhat they receive
Control GroupNo interventionParticipants 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 GroupExperimentalParticipants 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.
Receives: Other: Hysterectomy Adaptation Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks after training

  2. Hysterectomy Adaptation

    Adaptation to hysterectomy will be assessed using the Hysterectomy Adaptation Scale. Higher scores indicate better adaptation to life after hysterectomy.

    Measured: Changes in adaptation scores from baseline to 8 weeks after the intervention will be compared between

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07721727
Sponsor's protocol ID
05/1294
Acronym
HYSTADAPT
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

Questions about this trial

What is this clinical trial studying?

A study testing Hysterectomy Adaptation Education in people with Hysterectomy and Women, run by Ufuk University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hysterectomy Adaptation (time frame: 8 weeks after training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07721727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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