跳至主要内容
临床试验/NCT06730178
NCT06730178已完成不适用

Calo Psychiatric Center

Calo Psychiatric Center0 个研究点目标入组 24 人开始时间: 2009年1月1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
24
主要终点
the improvement of relaxation training tape

研究概览

简要总结

Background: The purpose of this study was to examine the improvement in insomnia patients using Relaxation Training, and to use the Generalized Estimating Equation model (GEE-I) to analyze the results of repeated measurements and observe the difference between the subjective perception and the objective measurement of sleep duration.

Methods: There were 24 subjects diagnosed as insomnia who completed the treatment course and 5 times evaluation. Of the 24 subjects, 7 accepted the sleep electroencephalogram (EEG). Relaxation training shortened the duration of sleep onset time and decreased the frequency of night awakening.

详细描述

Of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process.The patients were asked to keep a sleep diary. In the diaries, they recorded the time they went to bed and fell asleep, the duration to sleep onset (from "go to the bed" to "fall asleep"), the frequency of night waking, the time of getting up, and any medication history. Patients were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process. All subjects had been diagnosed as having primary insomnia or insomnia related to medical and psychiatric comorbid diagnoses using the D Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria.

入排标准

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

入选标准

  • All subjects had been diagnosed as having primary insomnia or insomnia related to medical and psychiatric comorbid diagnoses using the D Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria.

排除标准

  • Patients who had comorbid serious medical illnesses, and pregnant and lactating women were excluded.

结局指标

主要结局

the improvement of relaxation training tape

时间窗: 4 weeks

Participants were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.

次要结局

未报告次要终点

研究者

发起方
Calo Psychiatric Center
申办方类型
Other
责任方
Sponsor

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