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NCT Number: NCT03702296

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

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.

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Key information

Conditions

Sleep Critical Care Major Abdominal Surgery

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore General Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2018
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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