Post-Hysterectomy Nursing Support Program

Sponsor

Suleyman Demirel University (Other)

Overall Status

Completed

CT.gov ID

NCT05063864

Collaborator

(none)

Enrollment

Location

Arms

19.1

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: This study was conducted to evaluate the effectiveness of the nursing support program developed for women undergoing hysterectomy.

Background: Hysterectomy is an important surgical intervention that affects women physically, sexually and psychosocially.

Method: The study is a single blind, randomized controlled study conducted at the Department of Obstetrics and Gynecology in a university hospital between November 2017 and November 2018. 60 women who had hysterectomy were divided into experimental and control groups and It was evaluated on the 1-2 day, 6-7 day and 2nd month. In the study, the nursing support program was applied only to women in the experimental group.

Condition or Disease	Intervention/Treatment	Phase
Hysterectomy	Other: Nursing Support Program	N/A

Detailed Description

Aim: This study was conducted to evaluate the effectiveness of the nursing support program developed for women who had hysterectomy.

Methods: A prospective, randomised controlled study was conducted in the gynaecology clinic of a university hospital between November 2017 and November 2018. It was conducted in a single-blind, randomised controlled trial with a total of 60 women in the experimental and control groups. A nursing support program had been developed for women who have had a hysterectomy. The program developed for the experimental group and the routine program for routine maintenance and control group were applied. The initial evaluation was carried out postoperative on the 1st-2nd day, the second assessment was carried out on the 6th-7th day and the third evaluation was carried out at 2 months. The first interview was carried out in the hospital, and the second and third interviews were carried out with home visits. The sociodemographic data form, postoperative evaluation form, Female Sexual Function Index (FSFI), Epidemiological Studies and Central Depression Scale (EAMDS), Menopausal Symptoms Evaluation Scale (MSDS) and SF-12 quality of life scale were used to collect data.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Determining the Effectiveness of the Post-Hysterectomy Nursing Support Program: Randomized Controlled Study

Actual Study Start Date :

Nov 20, 2017

Actual Primary Completion Date :

Nov 15, 2018

Actual Study Completion Date :

Jun 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nursing Support Program the group that applied the nursing support program	Other: Nursing Support Program Within the scope of the nursing support program, counselling services were provided to women by making regular phone calls that lasted 15-20 minutes once a week. Within the scope of the support program, two training booklets titled "Life After Hysterectomy Surgery" and "Women's Health During Menopause" were prepared by reviewing the literature.
No Intervention: No Nursing Support Program the group that did not receive a nursing support program

Arm

Intervention/Treatment

Experimental: Nursing Support Program

the group that applied the nursing support program

Other: Nursing Support Program

Within the scope of the nursing support program, counselling services were provided to women by making regular phone calls that lasted 15-20 minutes once a week. Within the scope of the support program, two training booklets titled "Life After Hysterectomy Surgery" and "Women's Health During Menopause" were prepared by reviewing the literature.

No Intervention: No Nursing Support Program

the group that did not receive a nursing support program

Outcome Measures

Primary Outcome Measures

Nursing Support Program [postoperative on the 2 months.]
Change of postoperative symptoms in the postoperative data sheet at 2 months after hysterectomy, Change of sexual functions in female sexual function index (FSFI) 2 months after hysterectomy Change of mental status in epidemiological depression scale (CES-D) 2 months after hysterectomy Change in quality of life in SF-12 quality of life scale at 2 months after hysterectomy Change in menopausal symptoms in the menopausal symptoms rating scale (MRS) 2 months after hysterectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis benign hysterectomy and bilateral oophorectomy
Having no communication problems.

Exclusion Criteria:

Clinical diagnosis vaginal hysterectomy
Clinical diagnosis psychiatric disorders and therefore used drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suleyman Demirel University	Isparta		Turkey

Sponsors and Collaborators

Suleyman Demirel University

Investigators

Principal Investigator: Kübra Yilmaz, Suleyman Demirel University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kübra Yılmaz, Principal Investigator, Suleyman Demirel University

ClinicalTrials.gov Identifier:

NCT05063864

Other Study ID Numbers:

KYilmaz

First Posted:

Oct 1, 2021

Last Update Posted:

Oct 1, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kübra Yılmaz, Principal Investigator, Suleyman Demirel University

hysterectomy

nursing support program,

Study Results

No Results Posted as of Oct 1, 2021