Clinical trial NCT06268158: The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit
Official title: The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit Following Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Surgery
Keywords: abdominal surgery
delirium
sleep quality
eye patch
music
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.

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.


Eligibility criteria: Inclusion Criteria:

* Those who have had abdominal surgery
* 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:

* Those who experience blood loss and fluid electrolyte imbalance after surgery
* 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.

Primary outcomes:
measure: Richard-Campbell Sleep Scale
timeFrame: day 1 and 4 of the study
measure: Nursing Delirium Screening Scale
timeFrame: day 1 and 4 of the study
Secondary outcomes:
measure: Richmond Agitation-Sedation Scale
timeFrame: day 1
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
state: Talas
Study officials:
affiliation: TC Erciyes University
name: Yeliz Sürme, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.