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临床试验/NCT05697133
NCT05697133尚未招募不适用

The Effect of Symptom Management Program Based on Story Theory on Vasomotor Symptoms and Sleep Quality in Postmenopausal Women

Ondokuz Mayıs University0 个研究点目标入组 76 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
主要终点
Menopause Symptoms Rating Scale

研究概览

简要总结

Purpose: To investigate the effect of the Symptom Management Program Based on Story Theory on vasomotor symptoms and sleep quality in postmenopausal women.

Design: The type of this research is mixed method (qualitative and quantitative research design together). It enables to strengthen the weaknesses of mixed method research, to increase the generalizability of the results, and to produce more reliable outputs regarding theory and practice. The quantitative research dimension is a randomized single-blind pretest-posttest experimental model with a control group. The qualitative research dimension is the descriptive phenomenological design.

Method: The research will be carried out at Ömürevleri, Atakum, Mimar Sinan, Çobanlı and Yenimahalle Family Health Centers located in different regions of the Atakum District of Samsun. After informing the women who come to the Family Health Centers about the face-to-face research, the research will be conducted completely online (due to the COVID-19 pandemic) after the verbal consent of the women who volunteered to participate in the research and their contact numbers are obtained. The postmenopausal women who apply to the institutions where the research will be conducted and meet the inclusion criteria constitute the population of the research. When the sample size calculated with the G.Power program was taken as Pittsburgh Sleep Quality Index score mean and standard deviation value as 6.57±1.23, with 5% significance level, 80% test power, 0.700 effect size, there were at least 68 groups, 34 for the experimental group and 34 for the control group. identified as a person. Considering the sample loss in the experimental and control groups, with 10% more sampling, a total of 76 women will be included in the sample, with 38 women in each group. n the study, the data will be collected with the Personal Information Form, the Menopause Symptoms Assessment Scale, the Pittsburgh Sleep Quality Index and the Story Theory Based Semi-Structured Interview Form (for qualitative research) developed by the researchers in line with the literature. As a result of the study, the data will be evaluated separately as qualitative and quantitative.

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
Single (Participant)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Be a volunteer,
  • To be literate to have a smart mobile phone/computer
  • To be in the first 2 years after menopause
  • Experiencing vasomotor symptoms

排除标准

  • Having a communication barrier
  • Having problems with internet access
  • Being in the premenopausal period
  • Undergoing surgical menopause
  • Getting a diagnosis of respiratory system
  • Getting a diagnosis of hypertension and cardiovascular disease
  • Getting treatment for menopause, getting training on breathing exercises
  • Treatment for sleep disorders receive

结局指标

主要结局

Menopause Symptoms Rating Scale

时间窗: 1st months

It will be used to evaluate menopaus symptoms of postmenoposal women

The Pittsburgh Sleep Quality Index

时间窗: 1st months

It will be used to measure sleep qualıty of postmenoposal women

次要结局

  • The Pittsburgh Sleep Quality Index(3rd months)
  • Menopause Symptoms Rating Scale:(3rd months)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emel Guven

Research Assistant

Ondokuz Mayıs University

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