NCT07539558

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

March 12, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

HysterectomyNursingQuality of RecoverySelf- EfficacyDischarge EducationOrem's Self-Care ModelGynecological hysterectomyPostoperative recovery

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    4 weeks

Study Arms (2)

Education group

EXPERIMENTAL

Discharge education based Orem's Self Care Theory

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

Interventions

discharge education led by a nurse based Orem's Self Care Theory

Also known as: discharge education, discharge training
Education group

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgible participants are biologically female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University

Çorum, Çorum, 19120, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Since the study employed an educational intervention as an intervention, blinding the participants to their groups was not possible.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Randomised Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 12, 2026

First Posted

April 20, 2026

Study Start

December 1, 2024

Primary Completion

May 31, 2025

Study Completion

July 1, 2025

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Age, education level, marital status, income level, family type, partner's age and the other quantitative data

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
01/ DEC/ 2026 "5 years after study completion
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.
More information

Locations