The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit
NCT ID: NCT06268158
Last Updated: 2024-07-08
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
45 participants
INTERVENTIONAL
2023-04-01
2024-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.Considering possible sample loss, the study was completed with 45 patients, 21 in the experimental group and 24 in the control group.
During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, were used.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Using Eye Mask and Earplugs on Prevention of Delirium
NCT05000476
Reducing Delirium in the Surgical Intensive Care Unit
NCT02856737
The Association Between the Extubation Process and Delirium in the Intensive Care Unit
NCT07196813
Preoperative Sleep Quality and Postoperative Delirium
NCT06273358
Prevention of Delirium in ICU Using Multimodal Interventions
NCT05950958
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Patients in the experimental group will wear an eye patch after 22:00, when clinical interventions are less frequent, and will be listened to calming music once a day for 1 hour for 3 days.
Eye patch
The experimental group will fill out the patient introduction form, Richmond Agitation-Sedation Scale, Nursing Delirium Screening Scale and Richard-Campbell Sleep Scale on the first day. On the 4th day of the study, the Nursing Delirium Screening Scale and the Richard-Campbell Sleep Scale will be completed.
Control group
No treatment will be performed on patients in the control group outside of their clinical routine.
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 patch
The experimental group will fill out the patient introduction form, Richmond Agitation-Sedation Scale, Nursing Delirium Screening Scale and Richard-Campbell Sleep Scale on the first day. On the 4th day of the study, the Nursing Delirium Screening Scale and the Richard-Campbell Sleep Scale will be completed.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Those who volunteer to participate in the research
* Those who are over 18 years old
* Richmond Agitation-Sedation Scale -1, 0, +1
* Those who have been in intensive care for at least 3 days
* No communication problems (language, hearing impairment, etc.)
* No mental problems
* Patients who do not use sleeping pills or sedating drugs and who do not have alcohol or substance addiction will be included in the study.
Exclusion Criteria
* There are contraindications to the use of eye masks (for example, head trauma),
* Patients with delirium before or after surgery will not be included in the study.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TC Erciyes University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yeliz Sürme
Assoc.Prof. Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yeliz Sürme, PhD
Role: PRINCIPAL_INVESTIGATOR
TC Erciyes University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erciyes University
Kayseri, Talas, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Puppo Moreno AM, Abella Alvarez A, Morales Conde S, Perez Flecha M, Garcia Urena MA. The intensive care unit in the postoperative period of major abdominal surgery. Med Intensiva (Engl Ed). 2019 Dec;43(9):569-577. doi: 10.1016/j.medin.2019.05.007. Epub 2019 Aug 1. English, Spanish.
Linke GR, Mieth M, Hofer S, Trierweiler-Hauke B, Weitz J, Martin E, Buchler MW. Surgical intensive care unit - essential for good outcome in major abdominal surgery? Langenbecks Arch Surg. 2011 Apr;396(4):417-28. doi: 10.1007/s00423-011-0758-y. Epub 2011 Mar 3.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023/45
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.