The Effect of Progressive Relaxation Exercises on Sleep Quality

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647148
• Other study ID #: AU-TELIS
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2022
• Source: Ataturk University
• Contact: Tunç ELIS
• Phone: 04742426840
• Email: tuncelis[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Nursing Care
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Progressive Relaxation Exercises
In the first part of this audio material, which consists of three parts; The definition of deep relaxation, its purpose and points to be considered during exercise are included. The second part, consisting of an average of thirty minutes, includes the explanation of relaxation exercises with verbal commands accompanied by the sound of the stream. In the last part, there is only relaxation music without any commands.

Locations

Country	Name	City	State
Turkey	Ataturk Üniversity	Erzurum
Turkey	Atatürk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep quality,	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".	06.00 am the day before the progressive relaxation exercise
Primary	melatonin and serotonin in urine	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.	06.00 am the day before the progressive relaxation exercise
Secondary	sleep quality,	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".	06.00 am, after 3 consecutive days of progressive relaxation exercise
Secondary	melatonin and serotonin in urine	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.	06.00 am the day after the progressive relaxation exercise