The Effect of Nursing Support Program for Women in Surgical Menopause on Their Life Quality
1 other identifier
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
1 active site
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
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2021
CompletedFirst Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedApril 12, 2023
March 1, 2023
1.1 years
March 30, 2023
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Life quality
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.
6 months
Sleep quality
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.
6 months
Depressive symptom status
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".
6 months
Study Arms (2)
Investigation Group
EXPERIMENTALEducation 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.
Control Group
ACTIVE COMPARATORRoutine nursing care was given to the control group. The clinical routine has not been exceeded.
Interventions
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.
Routine nursing care was given to the control group. The clinical routine has not been exceeded. It includes discharge training for the surgery.
Eligibility Criteria
You may qualify if:
- To have undergone surgical menopause
- To be literate
- To agree to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mehtap Gümüşaylead
Study Sites (1)
Ordu University
Ordu, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 12, 2023
Study Start
January 20, 2020
Primary Completion
February 18, 2021
Study Completion
July 30, 2021
Last Updated
April 12, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share