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临床试验/NCT04515381
NCT04515381已完成不适用

Mardin Artuklu University Of Scientific Research Projects

Mardin Artuklu University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2018年4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
104
试验地点
1
主要终点
Change in Pittsburgh Sleep Quality Index

研究概览

简要总结

Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery.

Design: Randomized placebo-controlled study.

详细描述

The trial was conducted between April and July 2018. The students who met the inclusion criteria were separated into three groups through randomization method as in therapeutic touch (n=32), placebo (n=32) and control (n=32), and a total of 96 students participated in the study. In this randomized placebo controlled study, the therapeutic touch group were subjected to therapeutic touch for twice a week throughout 4 weeks with each session of 20 minutes. The data was acquired via Student Information Form, Epworth Sleepiness Scale, Pittburgh Sleep Quality Index, Perceived Stress Scale and Visual Analogue Scale for Fatigue.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • students who were at and above the age of 18,
  • were the 1st year, 2nd year, 3rd year or 4th year students of nursing or midwifery,
  • did not receive any energy therapy (Reiki, healing touch, therapeutic touch),
  • received a score above 10 from the Epworth sleepiness scale (ESS),
  • did not have any communication problem,
  • and accepted to take part in the study were included in the study.

排除标准

  • Students who were getting a psychologic and/or pharmacologic treatment in regard to their sleep, fatigue and stress problems,
  • previously got a psychiatric diagnosis, still had a psychiatric illness,
  • previously or still used anxiety (psychotropic) medicines were excluded from the study.

结局指标

主要结局

Change in Pittsburgh Sleep Quality Index

时间窗: Change from baseline and 4 weeks.

In PSQI analysis, 18 items were scored and there are 7 categories as in subjective sleep quality, delayed sleep, sleep duration, accustomed sleep activity, sleep disorder, use of sleeping pill and daytime dysfunction. Total score varies from 0 to 21. If the total PSQI score is ≤5, it stands for "good sleep quality", and if the score is \>5, it stands for "bad sleep quality"

Change in Perceived Stress Scale

时间窗: Change from baseline and 4 weeks.

The score of PSS-10 varied from 0 to 40. High score shows the excessiveness of the perceived stress of the individual

Change in Visual Analogue Scale

时间窗: Change from baseline and 4 weeks.

The scale of fatigue is a scale of 10 cm that assesses the severity of the fatigue in the last week. The left side of the scale contains the label of "I do not feel fatigue", while the right side of the scale contains the label of "I Feel Extreme Fatigue and Exhaustion". VASF value is determined through the measurement of the distance between the very left side of the scale and the marked point

Change in Epworth Sleepiness Scale

时间窗: Change from baseline and 4 weeks.

The scale consists of 8 items and score varies from 0-24. If the total score is between 2-10, it is considered as normal, pathological sleepiness indicator is greater than 10, thirteen and higher values are considered excessive daytime sleepiness.

次要结局

未报告次要终点

研究者

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

Birgül Vural Doğru

Assistant Professor

Mardin Artuklu University

研究点 (1)

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