Clinical trial NCT03702296: Can the Use of Ear Plugs and Eye Masks Help to Improve Sleep Quality After Major Abdominal Surgery?
Official title: Can the Use of Ear Plugs and Eye Masks Help to Improve Sleep Quality After Major Abdominal Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Major Abdominal Surgery
Critical Care
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The importance of good sleep has been gaining interest in critically ill patients as poor sleep is associated with increased rates of delirium, non-invasive ventilation failure and stress to the patient.

The use of earplugs and eye masks has been shown to result in longer sleep time and better sleep quality. The primary outcome of this randomized control trial is to evaluate if the use of eye masks and earplugs in patients undergoing major abdominal surgery will lead to improved sleep quality. Secondary outcomes include the level of noise intensity in the various monitored units, incidence of delirium, nursing demand, length of hospitalization and anaesthetic techniques. With these findings, we hope to be able to improve patients' overall satisfaction with the healthcare received.

Detailed description: The importance of good sleep has been gaining interest in critically ill patients as poor sleep has been found to be associated with increased rates of delirium, non-invasive ventilation failure, and may serve as a stressor to patients. The use of earplugs and eye masks to improve sleep quality has been described in the critically ill patient population and outcomes have suggested that such interventions have resulted in longer sleep time and Rapid Eye Movement sleep, shorter sleep onset latency and less awakenings, with an enhanced perceived sleep quality. In the post-anaesthesia care unit, these interventions have also led to significantly preserved sleep quality in patients. The primary outcome of this randomized control trial is to evaluate if the use of eye masks and earplugs in patients undergoing major abdominal surgery, and who will be admitted to a monitored unit postoperatively, will lead to improved sleep quality. Secondary outcomes evaluated include the level of noise intensity in the various monitored units (Intensive Care Unit/Intermediate Care Area/High Dependency Ward), incidence of delirium, nursing demand, length of hospitalization and anaesthetic techniques. With these findings, we hope to be able to improve patients' overall satisfaction with the healthcare received.

Eligibility criteria: Inclusion Criteria:

* All patients who are 21 years old and above, undergoing elective major abdominal surgery in Singapore General Hospital, and who are anticipated to require a monitored bed postoperatively will be identified via Operating Theatre Management system the day before surgery. Postoperatively, these patients must have a Glasgow Coma Scale of at least 10, able to obey verbal commands and stay in a monitored unit postoperatively (Intensive Care Unit/Intermediate Care Area/High Dependency).

Exclusion Criteria:

* Patients who have known hearing impairment, dementia, confusion, delirium or with a tracheostomy will be excluded.

Primary outcomes:
measure: Comparison of sleep quality between the 2 arms based on Richard Campbell sleep questionnaire
timeFrame: 3 days
Secondary outcomes:
measure: Comparison of overall patient satisfaction between the 2 arms based on Richard Campbell sleep questionnaire
timeFrame: 3 days
measure: Frequency of nursing interventions required during the night
timeFrame: 3 days
measure: Incidence of delirium, based on twice daily scoring on the Neecham Confusion Tool
timeFrame: 3 days
measure: Duration of hospitalisation
timeFrame: through study completion, an average of 1 year
measure: Noise intensity in the various monitored care units
timeFrame: 3 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
citation: Leong RW, Davies LJ, Fook-Chong S, Ng SY, Lee YL. Effect of the use of earplugs and eye masks on the quality of sleep after major abdominal surgery: a randomised controlled trial. Anaesthesia. 2021 Nov;76(11):1482-1491. doi: 10.1111/anae.15468. Epub 2021 Apr 21.