Sleep DisturbanceNCT05647148
The Effect of Progressive Relaxation Exercises on Sleep Quality
A study testing Progressive Relaxation Exercises in people with Sleep Disturbance and Nursing Care, run by Ataturk University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Nursing Care
- What is being tested?
- Progressive Relaxation Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 9 May 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Atatürk University
Erzurum, 25000
reva balcı akpınar, prof., 0 442 2312694, hemsirelikfak@hotmail.com
- Recruiting
Ataturk Üniversity
Erzurum
reva balcı akpınar, prof, 05327173155, reva@atuni.edu.tr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Sleep Disturbance, Nursing Care
- Being tested
- Progressive Relaxation Exercises
- Keywords
- sleep quality, progressive relaxation Exercises, melatonin, serotonin
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | progressive relaxiation exercises Will do sixty minutes of progressive relaxation exercise for three consecutive days Receives: Behavioral: Progressive Relaxation Exercises |
| Control group: | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 06.00 am the day before the progressive relaxation exercise
Secondary 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".
Measured: 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.
Measured: 06.00 am the day after the progressive relaxation exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start9 May 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tunc ELIS, Ataturk University
- Investigators
- Tunç ELİŞ, Principal investigator, Kafkas Universıty/Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647148
- Sponsor's protocol ID
- AU-TELIS
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Sleep Quality, Serotonin, and Melatonin Levels of Heart Diseases Patients
- ClinicalTrials.gov ID
- NCT05647148
- Acronym / sponsor ID
- AU-TELIS
- Conditions
- Sleep Disturbance, Nursing Care
- Keywords
- sleep quality, progressive relaxation Exercises, melatonin, serotonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Progressive Relaxation Exercisesprogressive relaxiation exercises Will do sixty minutes of progressive relaxation exercise for three consecutive days |
| Control group: | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Relaxation ExercisesIn 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. | Behavioural | intervention group |
Primary outcome
sleep quality,
Time frame: 06.00 am the day before the progressive relaxation exercise
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
Time frame: 06.00 am the day before the progressive relaxation exercise
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.
2 secondary outcomes
sleep quality,
Time frame: 06.00 am, after 3 consecutive days of progressive relaxation exercise
melatonin and serotonin in urine
Time frame: 06.00 am the day after the progressive relaxation exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tunç ELİŞ principal investigator
Kafkas Universıty/Turkey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercises in people with Sleep Disturbance and Nursing Care, run by Ataturk University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tunç ELİŞ (04742426840 ext. 5032, tuncelis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality, (time frame: 06.00 am the day before the progressive relaxation exercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.