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临床试验/NCT05647148
NCT05647148招募中不适用

The Effect of Progressive Relaxation Exercises on Sleep Quality, Serotonin, and Melatonin Levels of Heart Diseases Patients

Ataturk University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
melatonin and serotonin in urine

研究概览

简要总结

This study; In order to investigate the effect of progressive relaxation exercises on sleep quality, serotonin and melatonin levels in cardiac patients with sleep problems, a pretest/posttest experimental design study will be conducted with a control group.

The data of this study will be collected between May 2022 and December 2022. The research will be carried out with a total of 60 (experimental group=30, control group=30) patients treated for heart failure, myocardial infarction and angina pectoris in the cardiology clinic of a university hospital.

The data of the study will be collected using the Richard's Campbell Sleep Scale and the Commercial ELISA kit.

Progressive relaxation exercises will be applied to the patients included in the experimental group for 3 consecutive days.

Before relaxation exercises, urine melatonin, serotonin level [5-hydroxyindolacetic acid (5-HIAA) and 6-sulphatoxymelatonin(6-HMS)] measurement and sleep quality will be measured according to the kit procedure.

In the analysis of the data, significance p <0.05 will be accepted. Institutional permission, ethics committee approval, and written consent from the participants were obtained before the study.

详细描述

The data of this study will be collected between May 2022 and December 2022. The research will be carried out with a total of 60 (experimental group=30, control group=30) patients treated for heart failure, myocardial infarction and angina pectoris in the cardiology clinic of a university hospital.

The study was planned as a randomized controlled experiment. Patients meeting the research criteria will be randomly assigned to 30 experimental-30 control groups by randomization method.

Information Form, Richard's Campbell Sleep Scale and commercial ELISA kit will be used as data collection tools in the research.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •older than 18 years of age,
  • •who reported sleep problems
  • •scored 25 or less on the Richard's Campbell Sleep Scale,
  • •were scheduled to be hospitalized for at least 4 days,
  • •had no pain, were able to give urine samples,
  • •were lying in a single or double room,
  • •had serotonin-containing or decreased serotonin secretion.
  • •do not take any medication that provides medical treatment,
  • •can do PGE,
  • •do not have a hearing problem or a communication disability will be admitted.

排除标准

  • •who were discharged early,
  • •had an unexpected change in their condition,
  • •started to experience pain,
  • •could not adapt to the working principles,
  • •gave up volunteering will be excluded from the study.

研究组 & 干预措施

intervention group

Experimental

progressive relaxiation exercises Will do sixty minutes of progressive relaxation exercise for three consecutive days

干预措施: Progressive Relaxation Exercises (Behavioral)

Control group:

No Intervention

no intervention

结局指标

主要结局

melatonin and serotonin in urine

时间窗: 06.00 am the day before the progressive relaxation exercise

In order to determine the levels of serotonin metabolite 5-hydroxyindolacetic acid (5-HIAA) and melatonin metabolite 6-sulphatoxymelatonin from patients in the experimental and control groups, urine samples will be taken between 23:00 at night and 07:00 in the morning at the end of the first and fourth day. On the 5th day, after the last urine taken in the morning is added, a urine sample will be taken into a sample container containing 10-15 ml of 6 M HCl and stored at -80 degrees for analysis in the biochemistry laboratory.

sleep quality,

时间窗: 06.00 am the day before the progressive relaxation exercise

Richard's Campbell Sleep Scale (RCS) consists of 6 items. In the scale, patients are asked to evaluate between 0 and 100 points for each item. The 6th item, which evaluates the noise level in the environment, is not included in the total score evaluation. The result is obtained by dividing the total score obtained from the scale by the number of questions, and "0-25" points indicate "very bad sleep" and "76-100" points indicate "very good sleep".

次要结局

  • melatonin and serotonin in urine(06.00 am the day after the progressive relaxation exercise)
  • sleep quality,(06.00 am, after 3 consecutive days of progressive relaxation exercise)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tunc ELIS

LECTURER

Ataturk University

研究点 (2)

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