The Effect of Nursing Support Program Developed in Accordance With Roy Adaptation Model for Women in Surgical Menopause on Their Life Quality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 77
- Locations
- 2
- Primary Endpoint
- Life quality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Life quality
Time Frame: 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
Time Frame: 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
Time Frame: 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".
Secondary Outcomes
No secondary outcomes reported
Investigators
Mehtap Gümüşay
Principal Investigator
Ordu University