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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05063864
Other study ID # KYilmaz
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2017
Est. completion date June 24, 2019

Study information

Verified date September 2021
Source Suleyman Demirel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 24, 2019
Est. primary completion date November 15, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Suleyman Demirel University Isparta

Sponsors (1)

Lead Sponsor Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nursing Support Program 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 postoperative on the 2 months.
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