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临床试验/NCT05809960
NCT05809960已完成不适用

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

Mehtap Gümüşay2 个研究点 分布在 2 个国家目标入组 77 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
2
主要终点
Life quality

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Life quality

时间窗: 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

时间窗: 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

时间窗: 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".

次要结局

未报告次要终点

研究者

发起方
Mehtap Gümüşay
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehtap Gümüşay

Principal Investigator

Ordu University

研究点 (2)

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