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The Effect of Progressive Relaxation Exercises on Sleep Quality

Primary Purpose

Sleep Disturbance, Nursing Care

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Relaxation Exercises
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Disturbance focused on measuring sleep quality, progressive relaxation Exercises, melatonin, serotonin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atatürk UniversityRecruiting
  • Ataturk ÜniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

Control group:

Arm Description

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

no intervention

Outcomes

Primary Outcome Measures

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".
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.

Secondary Outcome Measures

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".
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.

Full Information

First Posted
November 21, 2022
Last Updated
December 2, 2022
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05647148
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Nursing Care
Keywords
sleep quality, progressive relaxation Exercises, melatonin, serotonin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
progressive relaxiation exercises Will do sixty minutes of progressive relaxation exercise for three consecutive days
Arm Title
Control group:
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Progressive Relaxation Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
sleep quality,
Description
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".
Time Frame
06.00 am the day before the progressive relaxation exercise
Title
melatonin and serotonin in urine
Description
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.
Time Frame
06.00 am the day before the progressive relaxation exercise
Secondary Outcome Measure Information:
Title
sleep quality,
Description
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".
Time Frame
06.00 am, after 3 consecutive days of progressive relaxation exercise
Title
melatonin and serotonin in urine
Description
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.
Time Frame
06.00 am the day after the progressive relaxation exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tunç ELİŞ
Phone
04742426840
Ext
5032
Email
tuncelis@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tunç ELİŞ
Organizational Affiliation
Kafkas Universıty/Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atatürk University
City
Erzurum
ZIP/Postal Code
25000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
reva balcı akpınar, prof.
Phone
0 442 2312694
Email
hemsirelikfak@hotmail.com
Facility Name
Ataturk Üniversity
City
Erzurum
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
reva balcı akpınar, prof
Phone
05327173155
Email
reva@atuni.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Progressive Relaxation Exercises on Sleep Quality

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