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临床试验/NCT04175652
NCT04175652已完成不适用

Effects of Laughter Yoga on Hemodialysis Patients' Plasma-Beta Endorphin Levels, Pain Levels and Sleep Quality: A Randomized Controlled Trial

Istanbul Sabahattin Zaim University2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年11月15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
68
试验地点
2
主要终点
Beta-endorphin Level

研究概览

简要总结

This study aimed to assess the effectiveness of laughter yoga on HD patients' plasma beta endorphin levels, pain levels and sleep quality.

详细描述

While there are studies conducted with laughter yoga on different patient groups in Turkey, no studies have been found on hemodialysis patients specifically. For this reason, it was thought that studies are needed which will prove the effect of laughter yoga practices on the plasma beta-endorphin levels, pain levels and sleep quality of hemodialysis patients.

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 (Investigator)

盲法说明

Single

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • receiving treatment in a dialysis center
  • must be between 18 and 80 years old and willing to participate in the study
  • receiving HD treatment at least twice a week for a month or longer
  • having a pain level and above
  • level of 5 above according to the Pittsburgh Sleep Quality Index.

排除标准

  • not taking any medicine for sleeping disorder
  • not having any visual, hearing or communication impairments
  • not having any mental disorders

结局指标

主要结局

Beta-endorphin Level

时间窗: 8 week

Blood samples were taken from all individuals who participated in the study, through their AVF fistulas by using 3.5 mL gel-based tubes and following antiseptic rules. Blood samples which were fully coagulated were centrifuged at 1500xg for 10 minutes and serums were obtained. The serum samples were separated into portions and kept at -80 °C until the analysis.

Visual Analog Scale

时间窗: 8 week

The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm

Pittsburgh Sleep Quality Index

时间窗: 8 week

The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is \>5 indicates "poor sleep"

次要结局

未报告次要终点

研究者

发起方
Istanbul Sabahattin Zaim University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zülfünaz ÖZER

PhD., Assistant Prof.

Istanbul Sabahattin Zaim University

研究点 (2)

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