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临床试验/NCT05850338
NCT05850338已完成不适用

Determination of the Effects of Autogenic Relaxation Exercise and Cold Pillow Application on Vasomotor Symptom Control and Quality of Life in Postmenopausal Women

Aylin Güneş2 个研究点 分布在 2 个国家目标入组 88 人开始时间: 2018年6月22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
88
试验地点
2
主要终点
frequency of vasomotor symptoms number

研究概览

简要总结

The aim of this study was to determine the effect of autogenic relaxation exercise and cold pillows on vasomotor symptom control and quality of life. This randomized controlled study was carried out at Kirikkale University Faculty of Medicine Hospital, Department of Obstetrics and Gynecology, Gynecology Department between 22.06.2018 and 02.01.2019. The sample of the study consisted of 88 people, 44 in the intervention group and 44 in the control group. Since there were case losses in the research, the research was completed with a total of 69 people, 34 in the intervention group and 35 in the control group. The women in the intervention group performed autogenic relaxation exercises and cold pillow application for 8 weeks, and the women in the control group received outpatient care in the hospital. Research data were collected using Descriptive Characteristics Form, Menopause-Specific Quality of Life Scale, Vasomotor Symptom and Practice Follow-up Diary. Data collection tools were applied to the women during the first interview, and at the 4th and 8th weeks after the women were included in the study. In the analysis of descriptive data; number, percentage, mean and standard deviation were used. Independent groups t test was used to determine the difference between groups. The relationship between two independent categorical variables was analyzed using the chi-square test. Variables between dependent groups were compared in repeated measurements with anova test and mixed anova test

详细描述

Aims:The aim of this study was to determine the effect of autogenic relaxation exercise and cold pillows on vasomotor symptom control and quality of life.

Hypothesis:H0-1: In the postmenopausal period, there was no difference in the frequency of vasomotor symptoms between the group that received autogenic relaxation exercise and cold pillows and the control group.

H1-1: In the postmenopausal period, there is a time difference in vasomotor symptom frequency between the autogenic relaxation exercise and cold pillow group and the control group.

H0-2: In the postmenopausal period, there was no difference in vasomotor symptom duration between the group that was applied autogenic relaxation exercise and cold pillow and the control group.

H1-2: In the postmenopausal period, there is a time difference in vasomotor symptom duration between the autogenic relaxation exercise and cold pillow group and the control group.

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 (Outcomes Assessor)

盲法说明

The data of the study were entered by a person other than the researcher. Statistical analysis was performed by a person other than the researcher. Blinding was done during the evaluation of the data. Intervention and control groups were coded as 1 and 2. The analysis of the data coded in terms of groups was made by the statistician. After the statistical analysis, the coding for the intervention and control groups was explained. Statistical bias was controlled by this blanking technique.

入排标准

年龄范围
45 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Experiencing vasomotor symptoms at least twice a day Least literate Living within the borders of Kirikkale province Women who consented to participate in the study

排除标准

  • Those with hyperthyroidism, pheomacrocytoma, carcinoid syndrome, diabetes mellitus, cancer, tuberculosis, and other chronic infections (Since the symptoms in these diseases can mimic vasomotor symptoms or the disease may cause hot flashes)
  • Receiving hormone therapy other than estrogen in the last 12 months (as it affects ovarian function and increases the symptoms of hot flashes)
  • Receiving antidepressant and anxiolytic treatment regularly in the last 3 months (because these drugs reduce the symptoms of hot flashes)
  • Receiving herbal alternative treatment in the last 4 weeks (since these treatments have a prolonged effect)
  • Using other alternative and complementary medicine methods (as it may cause errors while evaluating the study results)
  • Having a Body Mass Index of 35 and above
  • Using Hormone Replacement Therapy
  • Women who had a condition that prevented them from using cold pillows (sensory disorder, mental state disorder, circulatory disorder, open wound, cold allergy, hypersensitivity to cold)

结局指标

主要结局

frequency of vasomotor symptoms number

时间窗: eight weeks

vasomotor symptoms experienced per day

次要结局

  • vasomotor symptom duration(eight weeks)

研究者

发起方
Aylin Güneş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aylin Güneş

Asistant Professor

Kırıkkale University

研究点 (2)

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