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

Not Applicable

Completed

• Conditions: Quality of Life; Nursing Caries; Surgical Menopause

• Registration Number: NCT05809960
• Lead Sponsor: Mehtap Gümüşay

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Primary Completion: 2021-02-18
• Study Completion: 2021-07-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

Ordu University; 🇹🇷 Ordu, Turkey