The Effect of Nursing Support Program for Women in Surgical Menopause on Their Life Quality

Sponsor

Mehtap Gümüşay (Other)

Overall Status

Completed

CT.gov ID

NCT05809960

Collaborator

(none)

Enrollment

Location

Arms

18.3

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: The aim of this study was to determine the effect of the nursing support program developed in line with the Roy Adaptation Model on the quality of life, sleep quality and depressive symptom status of women in surgical menopause.

Design: The study was a single-center, randomized, controlled trial. Setting: This study was carried out in the gynecology clinic of a training and research hospital in Türkiye.

Method: The participants were randomized into two equal groups: intervention and control. The nursing support program developed in addition to routine nursing care was applied to the intervention group. Routine nursing care was given to the women in the control group. Data were collected with "Personal Information Form", "Menopause-Specific Quality of Life Questionnare", "Pittsburgh Sleep Quality Index" and "Perimenopausal Depression Scale".

Hypothesis:

H0-a: Nursing support program developed in line with the Roy Adaptation Model has no effect on the quality of life of women who have undergone surgical menopause.

H0-b: Nursing support program developed in line with the Roy Adaptation Model has no effect on the sleep quality of women who have undergone surgical menopause.

H0-c: Nursing support program developed in line with the Roy Adaptation Model has no effect on the depressive symptom status of women who have undergone surgical menopause.

Condition or Disease	Intervention/Treatment	Phase
Nursing Caries Surgical Menopause Quality of Life	Other: Nursing support program Other: Routine nursing care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Nursing Support Program Developed in Accordance With Roy Adaptation Model for Women in Surgical Menopause on Their Life Quality

Actual Study Start Date :

Jan 20, 2020

Actual Primary Completion Date :

Feb 18, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigation Group Education was given, which was prepared in line with the Roy Adaptation Theory and considering the literature, including the problems experienced in menopausal periods and the approaches used to cope with them. The progressive relaxation exercise was explained and taught to the women and the first application was provided with the instructions. "Menopause and Life" booklet prepared in line with Roy Adaptation Theory was given to support the education given and to remember the information afterwards.	Other: Nursing support program It was discussed about the operation and surgical menopause that the woman will undergo after hospitalization for the operation. Education was given including the problems experienced during menopause and the approaches used to cope with them. Progressive relaxation exercises were taught and practiced. In order to carry out these procedures, an interview of approximately 45-60 minutes was held with each woman. During the program, four planned meetings were held. One of them was face-to-face and the others were phone calls. During the phone calls, the symptoms experienced by the women and their coping methods were discussed and the questions of the women were answered. The average of each phone call was 20-30 minutes.
Active Comparator: Control Group Routine nursing care was given to the control group. The clinical routine has not been exceeded.	Other: Routine nursing care Routine nursing care was given to the control group. The clinical routine has not been exceeded. It includes discharge training for the surgery.

Arm

Intervention/Treatment

Experimental: Investigation Group

Education was given, which was prepared in line with the Roy Adaptation Theory and considering the literature, including the problems experienced in menopausal periods and the approaches used to cope with them. The progressive relaxation exercise was explained and taught to the women and the first application was provided with the instructions. "Menopause and Life" booklet prepared in line with Roy Adaptation Theory was given to support the education given and to remember the information afterwards.

Other: Nursing support program

It was discussed about the operation and surgical menopause that the woman will undergo after hospitalization for the operation. Education was given including the problems experienced during menopause and the approaches used to cope with them. Progressive relaxation exercises were taught and practiced. In order to carry out these procedures, an interview of approximately 45-60 minutes was held with each woman. During the program, four planned meetings were held. One of them was face-to-face and the others were phone calls. During the phone calls, the symptoms experienced by the women and their coping methods were discussed and the questions of the women were answered. The average of each phone call was 20-30 minutes.

Active Comparator: Control Group

Routine nursing care was given to the control group. The clinical routine has not been exceeded.

Other: Routine nursing care

Routine nursing care was given to the control group. The clinical routine has not been exceeded. It includes discharge training for the surgery.

Outcome Measures

Primary Outcome Measures

Life quality [6 months]
Women's quality of life was evaluated with the Menopause-Specific Quality of Life Questionnaire. The questionnaire consists of 4 sub-dimensions. The score for each dimension is calculated separately. High scores from the questionnaire indicate low quality of life.
Sleep quality [6 months]
Sleep quality of women was evaluated with the Pittsburgh Sleep Quality Index. The index consists of 7 sub-dimensions. The score for each dimension is calculated separately.
Depressive symptom status [6 months]
Depressive symptom status of women was evaluated with the Perimenopausal Depression Scale. The scale consists of 5 subscales. Minimum point is "0" an maximum point is "48".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

To have undergone surgical menopause
To be literate
To agree to participate in the study

Exclusion Criteria:

To have natural menopause before the operation
To have an oncological disease
To have a psychiatric disease
To use sleeping pills
To use hormonal therapy
To have physical and mental disability
To have barrier to communication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ordu University	Ordu		Turkey

Sponsors and Collaborators

Mehtap Gümüşay

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehtap Gümüşay, Principal Investigator, T.C. ORDU ÜNİVERSİTESİ

ClinicalTrials.gov Identifier:

NCT05809960

Other Study ID Numbers:

OrduU-SBF-MG-1

First Posted:

Apr 12, 2023

Last Update Posted:

Apr 12, 2023

Last Verified:

Mar 1, 2023

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 Mehtap Gümüşay, Principal Investigator, T.C. ORDU ÜNİVERSİTESİ

Nursing support program

Roy Adaptation Model

Depressive symptom status

Sleep quality

Study Results

No Results Posted as of Apr 12, 2023