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临床试验/NCT06196372
NCT06196372已完成不适用

The Effect of Online Cognitive Awareness-Based Nursing Support for Premenopausal Women on Vasomotor Symptoms, Stress and Quality of Life

Bandırma Onyedi Eylül University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2022年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Personal Information Form

研究概览

简要总结

This randomized controlled study was conducted at Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital between 16.05.2022-30.06.2023. Research data were collected at the gynecology outpatient clinic. The sample of the study consisted of 74 (37-intervention, 37-control) premenopausal women who met the inclusion criteria and were placed by randomization. The data of the study were collected using "Personal Information Form, Mindful Attention Awareness Scale (MAAS), Visual Analogue Scale for Vasomotor Symptoms (VAS), Perceived Stress Scale (PSS) and Menopause-Specific Quality of Life Scale (MENQOL)". First, the pretests of the study were applied to women in the intervention and control groups. Afterwards, women in the intervention group underwent the MenoMind program for eight weeks, and women in the control group were left with routine clinical care. In the eighth week of the research, the "MenoMind Evaluation Form" was applied to the women in the intervention group to evaluate the MenoMind program. One month after the study was completed, post-tests were performed on the intervention and control groups.

详细描述

METHOD Purpose of the research This study aims to examine the effect of online cognitive awareness-based nursing support (MenoMind) for premenopausal women on vasomotor symptoms, stress and quality of life.

Type of research This study was planned as a randomized controlled experimental study. The study was conducted according to CONSORT guidelines.

Hypotheses of the research Hypothesis 1: MenoMind program increases the conscious awareness level of premenopausal women.

Hypothesis 2: The MenoMind program reduces vasomotor symptoms of premenopausal women.

Hypothesis 3: The MenoMind program reduces the stress level of premenopausal women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

入排标准

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

入选标准

  • •Being able to read and write,
  • •Being able to use the internet,
  • •Having a device that can use the internet (such as a smartphone or computer),
  • •Not having a diagnosed psychiatric disease,
  • •Not having a chronic disease
  • •Not using hormone replacement therapy,
  • •Age 40 and above and having symptoms of menstrual irregularity,
  • •Receiving an average score of two or more from Menopause-Specific Quality of Life Scale,
  • •Scoring three or more on the Visual Analogue Scale for Vasomotor Symptoms

排除标准

  • •There are situations that prevent the exercises from being performed,
  • •Participating in a mindfulness training program before.

研究组 & 干预措施

Control

No Intervention

The control group received no intervention and the women were left to routine clinical care.

Experimental: Intervention

Experimental

An online mindfulness nursing support program (MenoMind) was applied to this group for 8 weeks and lasting an average of 50 minutes.

干预措施: MenoMind intervention group (Other)

结局指标

主要结局

Personal Information Form

时间窗: 5th minute

The personal information form, created in line with the literature, aims to determine the socio-demographic characteristics of women in the premenopausal period; It is a form consisting of 13 items containing descriptive information specific to the individual (age, education, marital status, employment status, income level, vasomotor symptoms, smoking status and regular exercise status).

次要结局

  • Menopause-Specific Quality of Life Scale (MENQOL)(10th minute)
  • Perceived Stress Scale (PSS)(5th minute)
  • Visual Analog Scale for Vasomotor Symptoms (VAS)(2th minute)
  • Mindful Attention Awareness Scale (MAAS)(5th minute)

研究者

发起方
Bandırma Onyedi Eylül University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Aslan Demirtaş

Research Assistant

Bandırma Onyedi Eylül University

研究点 (1)

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