Can the Use of Ear Plugs and Eye Masks Help to Improve Sleep Quality After Major Abdominal Surgery?

NCT03702296 | Completed

• 1 other identifier: 2018/2288
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Major Abdominal Surgery; Critical Care

Outcome Measures

Primary Outcomes (1)

• Comparison of sleep quality between the 2 arms based on Richard Campbell sleep questionnaire

  3 days

Secondary Outcomes (5)

• Comparison of overall patient satisfaction between the 2 arms based on Richard Campbell sleep questionnaire

  3 days

• Frequency of nursing interventions required during the night

  3 days

• Incidence of delirium, based on twice daily scoring on the Neecham Confusion Tool

  3 days

• Duration of hospitalisation

  through study completion, an average of 1 year

• Noise intensity in the various monitored care units

  3 days

Study Arms (2)

Intervention

OTHER

Patients will be provided with ear plugs and eye masks, to be used from 10pm to 6am, for 3 days post-operatively.

Other: Ear plugs and eye masks

Control

NO INTERVENTION

No ear plugs or eye masks provided.

Interventions

Ear plugs and eye masks OTHER

Patients in the intervention arm will be provided with ear plugs and eye masks and instructed on the use of these during sleep

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (1)

• 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.

  PMID: 33881774 DERIVED

MeSH Terms

Interventions

Ear Protective Devices

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors will review the patients for 3 days post-operatively and assess sleep quality using the Richard-Campbell sleep questionnaire.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: October 11, 2018
• Study Start: August 29, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)