NCT05063864

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

September 1, 2021

Last Update Submit

September 21, 2021

Conditions

Keywords

hysterectomynursing support program,menopausal symptomssexualitydepressionquality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Nursing Support Program

EXPERIMENTAL

the group that applied the nursing support program

Other: Nursing Support Program

No Nursing Support Program

NO INTERVENTION

the group that did not receive a nursing support program

Interventions

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.

Nursing Support Program

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SexualityDepression

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorBehavioral Symptoms

Study Officials

  • Kübra Yilmaz

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2021

First Posted

October 1, 2021

Study Start

November 20, 2017

Primary Completion

November 15, 2018

Study Completion

June 24, 2019

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

I am not sure.

Locations