CraniotomyNCT04959968
The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.
A study testing eye patch and earplug in people with Craniotomy, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of using eye patch and earplugs on anxiety, patient comfort, and sleep quality after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Craniotomy
- What is being tested?
- eye patch and earplug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2021to 17 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective craniotomy and intensive care for at least 48 hours
- Glasgow Coma Scale score = 15
- Turkish literate
Who cannot join
- Diagnosis of sleep disorder
- Hearing and/or vision loss
- Hearing aid use
- Pregnant women
- Communication and/or cooperation problem
- Chronic pain medication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul
About this study
Official title: The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery
This study aims to evaluate the effects of using eye patch and earplugs on anxiety, patient comfort, and sleep quality after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.
Read the detailed description
This study was designed as a non-drug clinical study with 2 randomly selected groups to evaluate the effect of eye patch and earplug use on sleep quality, anxiety and comfort level in patients hospitalized in the intensive care unit after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.
- Conditions
- Craniotomy
- Being tested
- eye patch and earplug
- Keywords
- Anxiety, Sleep, Intensive Care, Surgical, Craniotomy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye patch and earplugDevice
The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00 Receives: Device: eye patch and earplug |
| Control group | No intervention | Standard care procedure will be applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Richards-Campbell Sleep Questionnaire
Sleep quality levels of the craniotomy cases
Measured: On the 1 day of craniotomy
The Richards-Campbell Sleep Questionnaire
Sleep quality levels of the craniotomy cases
Measured: Post-operative second day of craniotomy
Secondary outcomes (3)
The Hospital Anxiety and Depression Scale
Anxiety levels of the craniotomy cases
Measured: On the 1 day of craniotomy
The Hospital Anxiety and Depression Scale
Anxiety levels of the craniotomy cases
Measured: Post-operative second day of craniotomy
The General Comfort Questionnaire
General comfort levels of the craniotomy cases
Measured: Post-operative second day of craniotomy
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 start10 Jul 2021
- Primary completion10 Apr 2023
- Study completion17 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies 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
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959968
- Sponsor's protocol ID
- TaksimEğitim
- Status last verified
- Oct 2022
- First submitted
- 25 Jun 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery
- ClinicalTrials.gov ID
- NCT04959968
- Acronym / sponsor ID
- TaksimEğitim
- Conditions
- Craniotomy
- Keywords
- Anxiety, Sleep, Intensive Care, Surgical, Craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 17 Jun 2023 (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 aims to evaluate the effects of using eye patch and earplugs on anxiety, patient comfort, and sleep quality after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.
Detailed description
This study was designed as a non-drug clinical study with 2 randomly selected groups to evaluate the effect of eye patch and earplug use on sleep quality, anxiety and comfort level in patients hospitalized in the intensive care unit after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: eye patch and earplugAn eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00 |
| Control group | No intervention | –Standard care procedure will be applied to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective craniotomy and intensive care for at least 48 hours
- Glasgow Coma Scale score = 15
- Turkish literate
Key exclusion criteria (6 listed)
- Diagnosis of sleep disorder
- Hearing and/or vision loss
- Hearing aid use
- Pregnant women
- Communication and/or cooperation problem
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 patch and earplugThe use of eye patch and ear plugs in post-operative intensive care in craniotomy cases. | Device | Intervention group |
Primary outcome
The Richards-Campbell Sleep Questionnaire
Time frame: On the 1 day of craniotomy
Sleep quality levels of the craniotomy cases
The Richards-Campbell Sleep Questionnaire
Time frame: Post-operative second day of craniotomy
Sleep quality levels of the craniotomy cases
3 secondary outcomes
The Hospital Anxiety and Depression Scale
Time frame: On the 1 day of craniotomy
The Hospital Anxiety and Depression Scale
Time frame: Post-operative second day of craniotomy
The General Comfort Questionnaire
Time frame: Post-operative second day of craniotomy
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 21 Aug 2023.
- 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.
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 patch and earplug in people with Craniotomy, run by Taksim Egitim ve Arastirma Hastanesi 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 6 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 21 Aug 2023. 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?
The Richards-Campbell Sleep Questionnaire (time frame: On the 1 day of craniotomy). 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 21 Aug 2023.