Nursing CareNCT06973252
Sleep Quality in Surgical Intensive Care
A study testing Eye masks in people with Nursing Care and Intensive Care Unit ICU, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Care, Intensive Care Unit ICU, Sleep Quality
- What is being tested?
- Eye masks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had undergone abdominal surgery
- over 18 years of age,
- who speak Turkish,
- who have not received any diagnosis related to mental health,
- who are open to communication and co-operation
- Patients who voluntarily agreed to participate in the study
Who cannot join
- patients with a history of neurological or psychiatric disorders
- patients with any eye disease
- patients who are unable or unwilling to wear an eye mask
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Aydin, Zafer Mahallesi, 09010
About this study
Official title: The Effect of Eye Mask on Sleep Quality in Patients Hospitalised in Surgical Intensive Care Unit: Non-Randomised Experimental Study
It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care. It is recommended that complementary interventions that can be used to improve such sleep quality should be tested and supported by new studies. In this study, it was aimed to determine the effect of eye mask on sleep quality in patients admitted to the surgical intensive care unit after abdominal surgery.
Read the detailed description
Sleep is one of the basic needs to maintain and protect health and is a physiological state that occurs as a result of loss of consciousness, slowing of muscle activities, and decrease in neural activity for a certain period of time. Sleep quality is adversely affected as a result of physiological or psychological factors occurring in the perioperative period or disruptions in normal sleep phases due to environmental factors such as light and noise in the intensive care environment. Especially in surgical intensive care units (SICU), it is one of the units where deterioration in the sleep quality of patients is frequently experienced.
It is reported that improving sleep quality in intensive care units will support the recovery processes of patients in the clinical environment and shorten the duration of hospital stay. Non-pharmacological methods are frequently used in patients hospitalised in the intensive care unit. In the literature, there are research results on the positive effects of using eye patch and earplugs, listening to audio books, massage and aromatherapy, acupressure, music therapy, white noise application, reflexology massage and foot bath interventions on sleep quality.
Sleep is an important component of nursing management in surgical intensive care units and is one of the basic needs of patients. Surgical nurses who provide nursing care here should plan, implement and evaluate environmental arrangements and non-pharmacological interventions to improve the sleep quality of patients. Especially interventions such as eye mask can be used to control the environmental factor that negatively affects sleep quality in surgical intensive care units. In systematic reviews and meta-analyses on the method of sleep in intensive care unit patients, it is reported that the use of eye mask improves sleep quality, but more studies are needed to increase the quality of evidence. It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care.
- Conditions
- Nursing Care, Intensive Care Unit ICU, Sleep Quality
- Being tested
- 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 masksBehavioural
The intervention group patients were fitted with an eye mask designed by the researcher by placing a black fabric in the size of the mask between two three-layer surgical masks with Asfor brand soft elastic earphones and stapling the edges. The designed eye mask was cut with scissors according to the shape of the nose so that the mask would fit the eye exactly and prevent the light from entering the eye. A separate mask was used for each patient in the intervention group. Patients who were admitted to the NICU after surgery were evaluated for agitation-pain-delirium at 23:00 on postoperative days 0, 1, and 2, were told to wear their eye masks after the scale application, and the patients were allowed to sleep at 23:00 at the latest. Patients were allowed to remove the eye patch for short periods of time (10 minutes or less at a time) and then put it back on when uncomfortable and when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group patients were fitted with an eye mask designed by the researcher by placing a black fabric in the size of the mask between two three-layer surgical masks with Asfor brand soft elastic earphones and stapling the edges. The designed eye mask was cut with scissors according to the shape of the nose so that the mask would fit the eye exactly and prevent the light from entering the eye. A separate mask was used for each patient in the intervention group. Patients who were admitted to the SICU after surgery were evaluated for agitation-pain-delirium at 23:00 on postoperative days 0, 1, and 2, were told to wear their eye masks after the scale application, and the patients were allowed to sleep at 23:00 at the latest. Patients were allowed to remove the eye patch for short periods of time (10 minutes or less at a time) and then put it back on when uncomfortable and when necessary. Receives: Behavioral: Eye masks |
| Control group | No intervention | Control group received the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep status
This form was developed by the researcher using the literature on the subject. The form was filled in based on the self-report of the patients. In order to determine the sleep status of the patients, the form included 5 statements: 'I feel tired and sleepy during the day despite sleeping for a sufficient amount of time', 'I have difficulty falling asleep 2-3 nights a week', 'I have to constantly move my legs in bed', 'I have to go to the toilet at least once during the night', 'I wake up tired and with a headache in the morning'.
Measured: On the 3rd postoperative day
Richmond Agitation Sedation Scale (RASS) Score
It is a ten-level scale developed by Cook and Palma (1989) in which eye contact, which is not present in other scales, is evaluated following the verbal stimulus. In the scale, a score of '0' indicates the ideal level where the patient is awake and calm, while values up to '+4' reflect increasing agitation and values up to '-5' reflect increasing sedation level. As the scale score increases, it is interpreted as the agitation status of the patients worsens.
Measured: Postoperative 1st, 2nd and 3rd days
Richard-Campbell Sleep Scale (RCS) Score
Richard-Campbell Sleep Scale (RCS): In 1987, the Turkish validity and reliability study of the scale was conducted by Richards in 2015 by Özlü and Özer. The scale consists of 6 items evaluating sleep quality, depth of sleep at night, frequency of awakening, ambient sound level, time of staying awake and time to fall asleep. Each item is evaluated on a scale ranging from 0 to 100. A score between '0-25' indicates very poor sleep and a score between '76-100' indicates very good sleep. As the scale score increases, patients' It is interpreted that sleep quality has increased.
Measured: Postoperative 1st, 2nd and 3rd days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start15 Nov 2022
- Primary completion15 Feb 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CareStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Arslan, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973252
- Sponsor's protocol ID
- Sleep Quality
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Mask on Sleep Quality in Patients Hospitalised in Surgical Intensive Care Unit: Non-Randomised Experimental Study
- ClinicalTrials.gov ID
- NCT06973252
- Acronym / sponsor ID
- Sleep Quality
- Conditions
- Nursing Care, Intensive Care Unit ICU, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 15 May 2025 (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.
It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care. It is recommended that complementary interventions that can be used to improve such sleep quality should be tested and supported by new studies. In this study, it was aimed to determine the effect of eye mask on sleep quality in patients admitted to the surgical intensive care unit after abdominal surgery.
Detailed description
Sleep is one of the basic needs to maintain and protect health and is a physiological state that occurs as a result of loss of consciousness, slowing of muscle activities, and decrease in neural activity for a certain period of time. Sleep quality is adversely affected as a result of physiological or psychological factors occurring in the perioperative period or disruptions in normal sleep phases due to environmental factors such as light and noise in the intensive care environment. Especially in surgical intensive care units (SICU), it is one of the units where deterioration in the sleep quality of patients is frequently experienced.
It is reported that improving sleep quality in intensive care units will support the recovery processes of patients in the clinical environment and shorten the duration of hospital stay. Non-pharmacological methods are frequently used in patients hospitalised in the intensive care unit. In the literature, there are research results on the positive effects of using eye patch and earplugs, listening to audio books, massage and aromatherapy, acupressure, music therapy, white noise application, reflexology massage and foot bath interventions on sleep quality.
Sleep is an important component of nursing management in surgical intensive care units and is one of the basic needs of patients. Surgical nurses who provide nursing care here should plan, implement and evaluate environmental arrangements and non-pharmacological interventions to improve the sleep quality of patients. Especially interventions such as eye mask can be used to control the environmental factor that negatively affects sleep quality in surgical intensive care units. In systematic reviews and meta-analyses on the method of sleep in intensive care unit patients, it is reported that the use of eye mask improves sleep quality, but more studies are needed to increase the quality of evidence. It is thought that transferring low-cost and easily applicable interventions that can be used to control environmental stressors such as noise and light that negatively affect sleep quality, especially in intensive care environments, into clinical practice will improve the quality of nursing care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Eye masksThe intervention group patients were fitted with an eye mask designed by the researcher by placing a black fabric in the size of the mask between two three-layer surgical masks with Asfor brand soft elastic earphones and stapling the edges. The designed eye mask was cut with scissors according to the shape of the nose so that the mask would fit the eye exactly and prevent the light from entering the eye. A separate mask was used for each patient in the intervention group. Patients who were admitted to the SICU after surgery were evaluated for agitation-pain-delirium at 23:00 on postoperative days 0, 1, and 2, were told to wear their eye masks after the scale application, and the patients were allowed to sleep at 23:00 at the latest. Patients were allowed to remove the eye patch for short periods of time (10 minutes or less at a time) and then put it back on when uncomfortable and when necessary. |
| Control group | No intervention | –Control group received the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- had undergone abdominal surgery
- over 18 years of age,
- who speak Turkish,
- who have not received any diagnosis related to mental health,
- who are open to communication and co-operation
Key exclusion criteria (3 listed)
- patients with a history of neurological or psychiatric disorders
- patients with any eye disease
- patients who are unable or unwilling to wear an eye mask
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 masksThe intervention group patients were fitted with an eye mask designed by the researcher by placing a black fabric in the size of the mask between two three-layer surgical masks with Asfor brand soft elastic earphones and stapling the edges. The designed eye mask was cut with scissors according to the shape of the nose so that the mask would fit the eye exactly and prevent the light from entering the eye. A separate mask was used for each patient in the intervention group. Patients who were admitted to the NICU after surgery were evaluated for agitation-pain-delirium at 23:00 on postoperative days 0, 1, and 2, were told to wear their eye masks after the scale application, and the patients were allowed to sleep at 23:00 at the latest. Patients were allowed to remove the eye patch for short periods of time (10 minutes or less at a time) and then put it back on when uncomfortable and when necessary. | Behavioural | Intervention group |
Primary outcome
Sleep status
Time frame: On the 3rd postoperative day
This form was developed by the researcher using the literature on the subject. The form was filled in based on the self-report of the patients. In order to determine the sleep status of the patients, the form included 5 statements: 'I feel tired and sleepy during the day despite sleeping for a sufficient amount of time', 'I have difficulty falling asleep 2-3 nights a week', 'I have to constantly move my legs in bed', 'I have to go to the toilet at least once during the night', 'I wake up tired and with a headache in the morning'.
Richmond Agitation Sedation Scale (RASS) Score
Time frame: Postoperative 1st, 2nd and 3rd days
It is a ten-level scale developed by Cook and Palma (1989) in which eye contact, which is not present in other scales, is evaluated following the verbal stimulus. In the scale, a score of '0' indicates the ideal level where the patient is awake and calm, while values up to '+4' reflect increasing agitation and values up to '-5' reflect increasing sedation level. As the scale score increases, it is interpreted as the agitation status of the patients worsens.
Richard-Campbell Sleep Scale (RCS) Score
Time frame: Postoperative 1st, 2nd and 3rd days
Richard-Campbell Sleep Scale (RCS): In 1987, the Turkish validity and reliability study of the scale was conducted by Richards in 2015 by Özlü and Özer. The scale consists of 6 items evaluating sleep quality, depth of sleep at night, frequency of awakening, ambient sound level, time of staying awake and time to fall asleep. Each item is evaluated on a scale ranging from 0 to 100. A score between '0-25' indicates very poor sleep and a score between '76-100' indicates very good sleep. As the scale score increases, patients' It is interpreted that sleep quality has increased.
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 22 May 2025.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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 in people with Nursing Care and Intensive Care Unit ICU, run by Aydin Adnan Menderes 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 6 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 22 May 2025. 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?
Sleep status (time frame: On the 3rd postoperative day). The study lists 3 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 22 May 2025.