Sleep QualityNCT05970614
The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients
A study testing Eye masks and ear plugs in people with Sleep Quality and Vital Signs, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Vital Signs
- What is being tested?
- Eye masks and ear plugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 16 Jan 2024
- 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
- 18 years and over,
- Able to answer all questions and communicate,
- Those who agreed to participate in the research
- Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index,
- Not sedating
- Not connected to a ventilator
- No hearing problem
- Glasgow Coma Score of 15
Who cannot join
- Connecting to the ventilator during operation
- Sedation during the study
- Wanting to leave the research during the study
- Being in the intervention group and removing the eye patch or earplug during sleep
- GCS falling below 15
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Osmaniye Public Hospital
Osmaniye, Merkez, 80000
About this study
Official title: The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients
This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.
Read the detailed description
The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.
- Conditions
- Sleep Quality, Vital Signs
- Being tested
- Eye masks and ear plugs
- Keywords
- sleep quality, vital signs, intensive care, ear plugs, eye masks
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye masks and ear plugsOther
Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No application will be made to the participants. Participants will receive routine care. |
| intervention group | Other | In addition to routine care, participants will be given eye masks and ear plugs for 3 days. Receives: Other: Eye masks and ear plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal questionnaire
It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.
Measured: Only one times. At the first meeting (up to one day).
Vital signs follow-up form
It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.
Measured: up to 3 days
Insomnia Severity Index
It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.
Measured: up to 3 days
Richards-Campbell Sleep Scale
The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Sep 2023
- Primary completion15 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies 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
- Model description
- randomized controlled trial with control and intervention groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, onur çetinkaya, PhD, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970614
- Sponsor's protocol ID
- OKU-SHMYO-OC-01
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2023
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT05970614
- Acronym / sponsor ID
- OKU-SHMYO-OC-01
- Conditions
- Sleep Quality, Vital Signs
- Keywords
- sleep quality, vital signs, intensive care, ear plugs, eye masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 1 Aug 2023 (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 planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.
Detailed description
The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial with control and intervention groups
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No application will be made to the participants. Participants will receive routine care. |
| intervention group | Other | Other: Eye masks and ear plugsIn addition to routine care, participants will be given eye masks and ear plugs for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and over,
- Able to answer all questions and communicate,
- Those who agreed to participate in the research
- Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index,
- Not sedating
Key exclusion criteria (5 listed)
- Connecting to the ventilator during operation
- Sedation during the study
- Wanting to leave the research during the study
- Being in the intervention group and removing the eye patch or earplug during sleep
- GCS falling below 15
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 |
|---|---|---|
| Eye masks and ear plugsEye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00. | Other | intervention group |
Primary outcome
Personal questionnaire
Time frame: Only one times. At the first meeting (up to one day).
It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.
Vital signs follow-up form
Time frame: up to 3 days
It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.
Insomnia Severity Index
Time frame: up to 3 days
It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.
Richards-Campbell Sleep Scale
Time frame: up to 3 days
The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.
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 7 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye masks and ear plugs in people with Sleep Quality and Vital Signs, run by Osmaniye Korkut Ata University 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 8 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: finished, as of the sponsor's last update on 7 Nov 2024. 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?
Personal questionnaire (time frame: Only one times. At the first meeting (up to one day).). The study lists 4 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 7 Nov 2024.