Post-Hysterectomy Nursing Support Program

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

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Other: Nursing Support Program

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey
    • Suleyman Demirel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Suleyman Demirel University
• Investigators: Principal Investigator: Kübra Yilmaz, Suleyman Demirel University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; depression; menopausal symptoms; hysterectomy; sexuality; nursing support program,
• Other Study ID Numbers: KYilmaz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: I am not sure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No