Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2022-11-15
2023-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients
NCT07309406
Effects of Acupressure Applied to Intensive Care Patients on Physiological Parameters, Pain, Sleep Quality, Anxiety and Perception of Nursing Presence
NCT06994715
Use of Comfort Theory In Intensive Care
NCT06781671
Multisensory and Cognitive Interventions in the ICU: Effects on Health and Recovery
NCT07116941
Eye Masks and Earplugs for Delirium and Pain Prevention in Pediatric Intensive Care Unit
NCT06867523
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
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.
Eye masks
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.
Control group
Control group received the usual care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eye masks
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* patients with any eye disease
* patients who are unable or unwilling to wear an eye mask
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aydin Adnan Menderes University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ezgi Arslan
PhD, Research Assisstant (Principal Investigator)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aydın Adnan Menderes University
Aydin, Zafer Mahallesi, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sleep Quality
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.