Clinical trial NCT05647148: The Effect of Progressive Relaxation Exercises on Sleep Quality
Official title: The Effect of Progressive Relaxation Exercises on Sleep Quality, Serotonin, and Melatonin Levels of Heart Diseases Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Nursing Care
Keywords: sleep quality
progressive relaxation Exercises
melatonin
serotonin
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: sleep quality,
timeFrame: 06.00 am the day before the progressive relaxation exercise
measure: melatonin and serotonin in urine
timeFrame: 06.00 am the day before the progressive relaxation exercise
Secondary outcomes:
measure: sleep quality,
timeFrame: 06.00 am, after 3 consecutive days of progressive relaxation exercise
measure: melatonin and serotonin in urine
timeFrame: 06.00 am the day after the progressive relaxation exercise
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
city: Erzurum
country: Turkey
facility: Ataturk Üniversity
Study officials:
affiliation: Kafkas Universıty/Turkey
name: Tunç ELİŞ
role: PRINCIPAL_INVESTIGATOR
References: