- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539558
The Effect of Discharge Education on Recovery Quality and Self-Efficacy After Hysterectomy
April 21, 2026 updated by: Derya Yuksel KOÇAK, Hitit University
Impact of Orem-Based Discharge Education on Recovery Quality and Self-Efficacy After Hysterectomy: A Randomized Controlled Study
This randomized controlled trial investigated the effect of discharge education based on Orem's Self-Care Theory on postoperative recovery quality and self-efficacy in women undergoing hysterectomy.
The study used a pretest/posttest control-group design and included 64 randomly selected women.
The study sample consisted of two groups: an intervention group (n=32) and a control group (n=32).
Data were collected between December 1, 2024, and May 31, 2025, from women who presented to the Obstetrics and Gynecology clinic of a training and research hospital in Çorum, Türkiye, and met the inclusion criteria.
Data were obtained using the Patient Demographic Information Form, the Quality of Recovery-40 Scale, and the General Self-Efficacy Scale.
Women in the intervention group received enhanced face-to-face discharge education based on the Orem Self-Care Theory before discharge, while the control group received standard face-to-face discharge education.
Pre-test data were collected via self-report in a hospital setting, while post-test data were collected by telephone at the 4th postoperative week from the intervention group, with the researcher marking the questionnaire responses.
The data were analyzed using SPSS version 26.0.
Descriptive statistics, Pearson chi-square test, independent samples t-tests, paired samples t-tests, and Fisher's exact test were used in the analysis of the data.
Study Overview
Status
Completed
Conditions
Detailed Description
In this study, women undergoing hysterectomy surgery will be randomly assigned to two groups.
The effects of routine, nurse-led, face-to-face discharge education will be compared with those of face-to-face discharge education based on OREM's self-care theory, focusing on quality of recovery and self-efficacy outcomes.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çorum
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Çorum, Çorum, Turkey (Türkiye), 19120
- Hitit University
-
-
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 voluntarily agree to participate in the study
- Women who have undergone hysterectomy
- Conscious and able to respond to questions
- Able to speak and understand Turkish
- No communication problems
- Literate with adequate reading comprehension
- No cognitive impairment
- No diagnosis of cancer
Exclusion Criteria:
- Women with hearing or speech impairments
- Women with cognitive impairment
- Women who underwent emergency hysterectomy
- Patients requiring intensive care in the postoperative period
- Women who do not agree to participate in the study
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education group
Discharge education based Orem's Self Care Theory
|
discharge education led by a nurse based Orem's Self Care Theory
Other Names:
|
|
No Intervention: Control Group
Routine Discharge education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Scale
Time Frame: 4 weeks
|
Developed by Sherer et al. in 1982, the scale is used to assess patients' general self-efficacy.
The original version of the scale, for which Turkish validity and reliability studies have been conducted, consisted of 23 items, while it was revised to 17 items by Yıldırım and İlhan (2010).
The scale consists of five-point Likert-type questions (1.
Never, 5. Very good).
It comprises three sub-dimensions: initiation (2, 4, 5, 6, 7, 10, 11, 12, 17), perseverance (3, 13, 14, 15, 16), and persistence (1, 8, 9).
The scoring ranges from 1 to 5, and questions 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse-scored.
The lowest possible score on the scale is 17, and the highest is 85.
A high score on the scale indicates a high level of self-efficacy belief.
In the validity and reliability study of the scale, the Cronbach's Alpha internal consistency coefficient was determined as 0.80 (Efendioğlu, 2024).
In this study, the Cronbach's Alpha internal consistency coefficient was found to be 0.8
|
4 weeks
|
|
The Quality of Recovery-40 Questionnaire
Time Frame: 4 weeks
|
Developed by Myles and colleagues in 2000, this scale assesses the quality of recovery in patients.
Its Turkish validity and reliability were established in 2014.
The Quality of Recovery-40 Questionnaire consists of 40 items encompassing five sub-dimensions: Emotional State (9 questions), Physical Comfort (12 questions), Patient Support (7 questions), Physical Independence (5 questions), and Pain (7 questions).
The Quality of Recovery-40 Questionnaire is divided into Part A and Part B. Part A addresses how the patient felt in the last 24 hours, and responses are requested for each item.
Part B inquires about the presence of specific physical or emotional symptoms in the last 24 hours.
Questions are evaluated using a 5-point Likert scale.
The total score is obtained by summing all items.
A score of 40 indicates "very poor quality of recovery," and a score of 200 indicates "excellent quality of recovery."
The Cronbach's alpha coefficient of the Quality of Improvement-40 Questionnaire w
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
December 1, 2024
Primary Completion (Actual)
May 31, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
March 12, 2026
First Submitted That Met QC Criteria
April 16, 2026
First Posted (Actual)
April 20, 2026
Study Record Updates
Last Update Posted (Actual)
April 24, 2026
Last Update Submitted That Met QC Criteria
April 21, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ethics number 2024-GOAEK-0424
- Master Thesis (Other Identifier: Hitit University)
- Ethic committee aproval number (Other Identifier: Hitit University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Age, education level, marital status, income level, family type, partner's age and the other quantitative data
IPD Sharing Time Frame
01/ DEC/ 2026 "5 years after study completion
IPD Sharing Access Criteria
De-identified individual participant data (IPD) and supporting documents (study protocol and informed consent form) will be available to qualified researchers who submit a reasonable request.
Access will be provided via secure email or institutional data-sharing platform after approval by the principal investigator.
Data will include study variables related to post-hysterectomy recovery, self-care education, and self-efficacy outcomes.
Personal identifiers will not be shared to ensure participant confidentiality.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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