Had Undergone a HysterectomyNCT07539558
The Effect of Discharge Education on Recovery Quality and Self-Efficacy After Hysterectomy
A study testing Discharge education based on Orem's self care theory led by a nurse only one time, face-to-face in people with Had Undergone a Hysterectomy and Had Not Been Diagnosed With Cancer, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Had Undergone a Hysterectomy, Had Not Been Diagnosed With Cancer, After Hysterectomy
- What is being tested?
- Discharge education based on Orem's self care theory led by a nurse only one time, face-to-face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Had Undergone a Hysterectomy, Had Not Been Diagnosed With Cancer, After Hysterectomy, Hysterectomy (MeSH nr: E04.950.300.399)
- Being tested
- Discharge education based on Orem's self care theory led by a nurse only one time, face-to-face
- Keywords
- Hysterectomy, Nursing, Quality of Recovery, Self- Efficacy, Discharge Education, Orem's Self-Care Model, Gynecological hysterectomy, Postoperative recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge education based on Orem's self care theory led by a nurse only one time, face-to-faceOther
Also called discharge education, discharge training
discharge education led by a nurse based Orem's Self Care Theory
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Discharge education based Orem's Self Care Theory Receives: Other: Discharge education based on Orem's self care theory led by a nurse only one time, face-to-face |
| Control Group | No intervention | Routine Discharge education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy Scale
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
Measured: 4 weeks
The Quality of Recovery-40 Questionnaire
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Dec 2024
- Primary completion31 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Had Undergone a HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomised Controlled Study
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Collaborators
- Erol Olcok Corum Training and Research Hospital
- Responsible party
- Principal investigator, Derya Yuksel KOÇAK, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539558
- Sponsor's protocol ID
- Ethics number 2024-GOAEK-0424
- Other IDs
- Ethic committee aproval number, Master Thesis
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Age, education level, marital status, income level, family type, partner's age and the other quantitative data
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Orem-Based Discharge Education on Recovery Quality and Self-Efficacy After Hysterectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07539558
- Acronym / sponsor ID
- Ethics number 2024-GOAEK-0424
- Conditions
- Had Undergone a Hysterectomy, Had Not Been Diagnosed With Cancer, After Hysterectomy, Hysterectomy (MeSH nr: E04.950.300.399)
- Keywords
- Hysterectomy, Nursing, Quality of Recovery, Self- Efficacy, Discharge Education, Orem's Self-Care Model, Gynecological hysterectomy, Postoperative recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Collaborators
- Erol Olcok Corum Training and Research Hospital
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Other: Discharge education based on Orem's self care theory led by a nurse only one time, face-to-faceDischarge education based Orem's Self Care Theory |
| Control Group | No intervention | –Routine Discharge education |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discharge education based on Orem's self care theory led by a nurse only one time, face-to-faceAlso: discharge education, discharge trainingdischarge education led by a nurse based Orem's Self Care Theory | Other | Education group |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. Age, education level, marital status, income level, family type, partner's age and the other quantitative data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge education based on Orem's self care theory led by a nurse only one time, face-to-face in people with Had Undergone a Hysterectomy and Had Not Been Diagnosed With Cancer, run by Hitit University at 1 site in Turkey (Türkiye).
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-Efficacy Scale (time frame: 4 weeks). 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?
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 24 Apr 2026.