The Effect of Progressive Relaxation Exercises on Sleep Quality

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance; Nursing Care
• Intervention / Treatment: Behavioral: Progressive Relaxation Exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tunç ELİŞ; Phone Number: 5032 04742426840; Email: tuncelis@hotmail.com

Study Locations

• Turkey
  • Erzurum, Turkey
    • Recruiting
    • Ataturk University
    • Contact: reva balcı akpınar, prof; Phone Number: 05327173155; Email: reva@atuni.edu.tr
  • Erzurum, Turkey, 25000
    • Recruiting
    • Ataturk University
    • Contact: reva balcı akpınar, prof.; Phone Number: 0 442 2312694; Email: hemsirelikfak@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; progressive relaxiation exercises Will do sixty minutes of progressive relaxation exercise for three consecutive days	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.
No Intervention: Control group: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: Tunç ELİŞ, Kafkas Universıty/Turkey

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: melatonin; sleep quality; serotonin; progressive relaxation Exercises
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: AU-TELIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No