CClinicalTrials.gg
Status unknownNCT05647148Updated Dec 12, 2022

The Effect of Progressive Relaxation Exercises on Sleep Quality

An interventional study of Progressive Relaxation Exercises in Sleep Disturbance and Nursing Care, sponsored by Ataturk University. Status unknown at 2 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-12.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled May 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Sleep Disturbance
  • Nursing Care

Keywords

  • sleep quality
  • progressive relaxation Exercises
  • melatonin
  • serotonin
03

In context

Dyssomnias

324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 251 interventional studies indexed under Dyssomnias.

Browse Dyssomnias studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    intervention group

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

    Behavioral: Progressive Relaxation Exercises

  • No intervention
    Control group:

    no intervention

Interventions

  • BehavioralProgressive 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.

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 06.00 am the day before the progressive relaxation exercise

  2. 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.

    Time frame: 06.00 am the day before the progressive relaxation exercise

Secondary outcomes

  1. 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".

    Time frame: 06.00 am, after 3 consecutive days of progressive relaxation exercise

  2. 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.

    Time frame: 06.00 am the day after the progressive relaxation exercise

07

Study locations

2 of 2 sites recruiting
  • Atatürk University
    Erzurum, 25000, Turkey
    Recruiting
  • Ataturk Üniversity
    Erzurum, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05647148
Lead sponsor
Ataturk University
Responsible party
Tunc ELIS (LECTURER, Ataturk University) — Principal investigator
First posted
Dec 12, 2022
Start date
May 9, 2022
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Dec 12, 2022

Study contacts

Tunç ELİŞ
Contact
tuncelis@hotmail.com
04742426840 ext. 5032
Tunç ELİŞ
principal investigator · Kafkas Universıty/Turkey

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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