Sleep DisturbanceNCT04959214
The Effect Of Progressıve Relaxatıon Exercıses
A study testing progressive relaxation egzersize in people with Sleep Disturbance and Fatigue, run by Seren at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit three times a week for 1 month on sleep quality and severity of fatigue. The research is a pretest-posttest randomized controlled study with an intervention control group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Fatigue
- What is being tested?
- progressive relaxation egzersize
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2020to 29 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Without a psychiatric diagnosis,
- Having a score of PUKI ≥5 and YŞÖ≥4,
- Nurses who volunteered to participate in the study were included in the research sample.
Who cannot join
- Experience of working in intensive care for less than 3 months,
- Using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine, antidepressant, anxiolytic and narcotic analgesics that affect sleep quality,
- Pregnant nurses were not included in the research sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Relaxation Exercises Applied to Nurses Working in the Intensive Care Unit on Sleep Quality and Fatigue Severity
This study was conducted to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit three times a week for 1 month on sleep quality and severity of fatigue. The research is a pretest-posttest randomized controlled study with an intervention control group.
Read the detailed description
The Effect of Progressive Relaxation Exercises Applied to Nurses Working in The İntensive Care Unit on Sleep Quality and Fatique İntensity The study was planned to determine the effect of progressive relaxation exercises applied to nurses working in intensive care units on sleep quality and fatigue intensity.
The study will be conducted with a randomized controlled experimental research design in order to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit on sleep quality and fatigue intensity. This randomized controlled study will be conducted on nurses working in Adana City Training and Research Hospital Intensive Care Unit. Nurses will be divided into 2 groups as experiment and control. It will be carried out on 60 people in total, 30 for the experimental group, 30 for the control group. Progressive relaxation exercises will be applied by nurses for 45 minutes, 3 days a week for an average of 1 month.
The data of the study will be collected after the purpose of the study is explained to the nurses and their verbal and written consents are obtained. In the collection of research data, the Personal Information Form prepared by the researchers and containing the introductory information of the nurses, the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index Scale PSQI), the Fatigue Severity Scale for fatigue (FSS) will be collected from control and intervention groups through face-to-face interviews.
There are a limited number of studies showing the effects of progressive relaxation exercises applied to intensive care nurses on sleep quality and fatigue intensity in our country. With the study, the use of these exercise programs, which can be easily applied by nurses who work under heavy workloads in the intensive care environment, will increase, and it will be ensured that nurses work more fit and efficiently and are supported in terms of sleep fatigue.
- Conditions
- Sleep Disturbance, Fatigue
- Being tested
- progressive relaxation egzersize
- Keywords
- Nurse, Progressive Relaxation, Sleep, Intensive Care, Fatigue
- Medical subject headings
- Parasomnias, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation egzersizeBehavioural
Performing exercises in a quiet environment for 45 minutes with the Turkish Psychologists Association CD. Filling the PSQI and FSS before and 1 month after the application
| Study group | Role | What they receive |
|---|---|---|
| intervention: progressive relaxation exercise practice group | Experimental | intervention: progressive relaxation exercise practice group: A group of 30 intensive care nurses who will practice the progressive relaxation exercise at home 3 days a week for 1 month. Receives: Behavioral: progressive relaxation egzersize |
| control: uninterrupted group | No intervention | control: A group of 30 intensive care nurses who did not intervene for 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-application fatigue severity rate of nurses working in the intensive care unit
Fatigue severity scale The scale developed by Krup (1989) is a nine-item scale that evaluates the overall effect of fatigue on daily activities.In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. The total score is calculated by taking the average of nine items. The cut-off value for pathological fatigue was determined as 4 and above. The lower the total score, the less fatigue.
Measured: Scales are filled before starting the application and at the end of the application after 1 month.
Decrease in sleep quality scale scores after the application
The Pittsburgh Sleep Quality Index (PUKI, PSQI) was developed in 1989 by Buysse et al. (Buysee et al, 1989) to evaluate sleep quality in the last month. The scale consists of a total of 24 questions, 19 of which were answered by the individual and five of them by the relatives of the individual.Each item score varies between "0" and "3", and the sum of the scores of the items in the seven components gives the scale score of 18.The total PUKI score ranges from 0 to 21. If this score is above 5, it indicates that the sleep quality of the individual is poor.
Measured: Scales are filled before starting the application and at the end of the application after 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start9 Sep 2020
- Primary completion12 Apr 2021
- Study completion29 Jun 2021
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.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seren, Cukurova University
- Investigators
- Songül Karadağ, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959214
- Sponsor's protocol ID
- 10359740
- Status last verified
- Jul 2021
- First submitted
- 29 Jun 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of intervention and control group scales before and after administration (statistical analysis) Introductory characteristics of the participants and participant consent form
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises Applied to Nurses Working in the Intensive Care Unit on Sleep Quality and Fatigue Severity
- ClinicalTrials.gov ID
- NCT04959214
- Acronym / sponsor ID
- 10359740
- Conditions
- Sleep Disturbance, Fatigue
- Keywords
- Nurse, Progressive Relaxation, Sleep, Intensive Care, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SerenUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 13 Jul 2021 (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 was conducted to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit three times a week for 1 month on sleep quality and severity of fatigue. The research is a pretest-posttest randomized controlled study with an intervention control group.
Detailed description
The Effect of Progressive Relaxation Exercises Applied to Nurses Working in The İntensive Care Unit on Sleep Quality and Fatique İntensity The study was planned to determine the effect of progressive relaxation exercises applied to nurses working in intensive care units on sleep quality and fatigue intensity.
The study will be conducted with a randomized controlled experimental research design in order to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit on sleep quality and fatigue intensity. This randomized controlled study will be conducted on nurses working in Adana City Training and Research Hospital Intensive Care Unit. Nurses will be divided into 2 groups as experiment and control. It will be carried out on 60 people in total, 30 for the experimental group, 30 for the control group. Progressive relaxation exercises will be applied by nurses for 45 minutes, 3 days a week for an average of 1 month.
The data of the study will be collected after the purpose of the study is explained to the nurses and their verbal and written consents are obtained. In the collection of research data, the Personal Information Form prepared by the researchers and containing the introductory information of the nurses, the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index Scale PSQI), the Fatigue Severity Scale for fatigue (FSS) will be collected from control and intervention groups through face-to-face interviews.
There are a limited number of studies showing the effects of progressive relaxation exercises applied to intensive care nurses on sleep quality and fatigue intensity in our country. With the study, the use of these exercise programs, which can be easily applied by nurses who work under heavy workloads in the intensive care environment, will increase, and it will be ensured that nurses work more fit and efficiently and are supported in terms of sleep fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention: progressive relaxation exercise practice group | Experimental | Behavioral: progressive relaxation egzersizeintervention: progressive relaxation exercise practice group: A group of 30 intensive care nurses who will practice the progressive relaxation exercise at home 3 days a week for 1 month. |
| control: uninterrupted group | No intervention | –control: A group of 30 intensive care nurses who did not intervene for 1 month |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Without a psychiatric diagnosis,
- Having a score of PUKI ≥5 and YŞÖ≥4,
- Nurses who volunteered to participate in the study were included in the research sample.
Key exclusion criteria (3 listed)
- Experience of working in intensive care for less than 3 months,
- Using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine, antidepressant, anxiolytic and narcotic analgesics that affect sleep quality,
- Pregnant nurses were not included in the research sample.
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 egzersizePerforming exercises in a quiet environment for 45 minutes with the Turkish Psychologists Association CD. Filling the PSQI and FSS before and 1 month after the application | Behavioural | intervention: progressive relaxation exercise practice group |
Primary outcome
Post-application fatigue severity rate of nurses working in the intensive care unit
Time frame: Scales are filled before starting the application and at the end of the application after 1 month.
Fatigue severity scale The scale developed by Krup (1989) is a nine-item scale that evaluates the overall effect of fatigue on daily activities.In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. The total score is calculated by taking the average of nine items. The cut-off value for pathological fatigue was determined as 4 and above. The lower the total score, the less fatigue.
Decrease in sleep quality scale scores after the application
Time frame: Scales are filled before starting the application and at the end of the application after 1 month.
The Pittsburgh Sleep Quality Index (PUKI, PSQI) was developed in 1989 by Buysse et al. (Buysee et al, 1989) to evaluate sleep quality in the last month. The scale consists of a total of 24 questions, 19 of which were answered by the individual and five of them by the relatives of the individual.Each item score varies between "0" and "3", and the sum of the scores of the items in the seven components gives the scale score of 18.The total PUKI score ranges from 0 to 21. If this score is above 5, it indicates that the sleep quality of the individual is poor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: Yes. Results of intervention and control group scales before and after administration (statistical analysis) Introductory characteristics of the participants and participant consent form
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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.
Songül Karadağ principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation egzersize in people with Sleep Disturbance and Fatigue, run by Seren at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-application fatigue severity rate of nurses working in the intensive care unit (time frame: Scales are filled before starting the application and at the end of the application after 1 month.). 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 13 Jul 2021.