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

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ClinicalTrials.gov Identifier: NCT03702296
Recruitment Status : Completed
First Posted : October 11, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sleep Major Abdominal Surgery Critical Care Other: Ear plugs and eye masks Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinded assessors will review the patients for 3 days post-operatively and assess sleep quality using the Richard-Campbell sleep questionnaire.
Primary Purpose: Prevention
Official Title: Can the Use of Ear Plugs and Eye Masks Help to Improve Sleep Quality After Major Abdominal Surgery?
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Intervention
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
Patients in the intervention arm will be provided with ear plugs and eye masks and instructed on the use of these during sleep
No Intervention: Control
No ear plugs or eye masks provided.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of sleep quality between the 2 arms based on Richard Campbell sleep questionnaire [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Comparison of overall patient satisfaction between the 2 arms based on Richard Campbell sleep questionnaire [ Time Frame: 3 days ]
  2. Frequency of nursing interventions required during the night [ Time Frame: 3 days ]
    Subjective assessment by nurses

  3. Incidence of delirium, based on twice daily scoring on the Neecham Confusion Tool [ Time Frame: 3 days ]
    Neecham Confusion Tool consists of 9 scoring components: Attention (score of 0-4), Command (score of 0-5), Orientation (0-5), Appearance (0-2), Motor Behaviour (0-4), Verbal Behaviour (0-4), Vital Function Stability (0-2), Oxygen Saturation Stability (0-2) and Urinary Continence Control (0-2). The sum of the scores from each component is combined into a Total Neecham Score, with higher scores indicating that the patient is less likely at risk of delirium.

  4. Duration of hospitalisation [ Time Frame: through study completion, an average of 1 year ]
  5. Noise intensity in the various monitored care units [ Time Frame: 3 days ]
    Measured using a sound detector, in decibels


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702296


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03702296    
Other Study ID Numbers: 2018/2288
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No