The Effect of Progressive Relaxation Exercises on Sleep Quality
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2022
CompletedFirst Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedDecember 12, 2022
December 1, 2022
8 months
November 21, 2022
December 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
sleep quality,
06.00 am, after 3 consecutive days of progressive relaxation exercise
melatonin and serotonin in urine
06.00 am the day after the progressive relaxation exercise
Study Arms (2)
intervention group
EXPERIMENTALprogressive relaxiation exercises Will do sixty minutes of progressive relaxation exercise for three consecutive days
Control group:
NO INTERVENTIONno intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Atatürk University
Erzurum, 25000, Turkey (Türkiye)
Ataturk Üniversity
Erzurum, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tunç ELİŞ
Kafkas Universıty/Turkey
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- LECTURER
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 12, 2022
Study Start
May 9, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
December 12, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share