SOULMAN Study - A Randomized Controlled Trial of Sound and Light Manipulation in the Emergency Department to Improve Sleep and the Patient Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Sleep Quality
研究概览
简要总结
Background The emergency department is a chaotic place with high levels of noise and light 24 hours a day. Patients are often boarded overnight while they await tests or consultations scheduled for the morning. Sleep deprivation, high noise levels have been associated with negative patient experiences and outcomes in other clinical settings. Interventions to counter the effects of noise and light in the emergency department for patients staying overnight have not been investigated.
Objective To determine if sleep and other aspects of the patient experience can be improved for patients boarded overnight in the Emergency Department with the use of a sleep mask and ear plugs.
Methods A randomized control study will take place in the Emergency Department of Kingston General Hospital. Eligible patients will randomized to receive either sleep aids (sleep mask and ear plugs) or standard treatment (no sleep aids). The primary outcome will be sleep quality, assessed by Richards-Campbell Sleep Questionnaire. Secondary outcomes include patient satisfaction, hours of sleep, blood pressure, heart rate, new-onset delirium, patient's sense of feeling well-rested and patient overall sense of well-being. The primary analysis will be intention-to-treat comparing primary and secondary outcomes between the two groups in an unadjusted fashion. A secondary analysis will involve linear regression to explore the association between treatment group and Richards-Campbell Sleep Score, controlling for potential confounders.
Importance Determining the feasibility and efficacy of sleep masks and earplugs for patients in the emergency department to improve sleep and the patient experience has never been done before. If found to be effective, this relatively low- cost intervention could be implemented in emergency departments across the country and around the world.
详细描述
Study Design This will be a randomized controlled trial.
Setting Kingston General Hospital is the Regional Trauma and Tertiary Care Center in Kingston, Ontario. The Emergency Department sees approximately 56,000 patients annually. It is staffed by Emergency Medicine Physicians, and residents in both the FRCP and CCFP-EM Emergency Medicine programs, as well as off-service residents.
Population This study will include a convenience sample of recruitment on weekdays when we have research assistance available. Specifically included are emergency department patients aged ≥18 years, GCS 15, who at 2300h are deemed likely by study personnel to board in the Emergency Department until at least 0700h the following morning while they wait for consultant assessments, investigations, or transfers.
Excluded patients include those previously enrolled in this study or involved in sleep research within last month, those who are legally blind or have a history of hearing impairment, a documented history of cognitive impairment, a positive delirium screen at enrollment, and those with a presenting complaint of head trauma. Also excluded are prisoners and those who cannot comprehend English.
Outcomes The primary outcome will be sleep quality as measured by a modified Richards-Campbell Sleep Questionnaire (RCSQ), completed by the patient at the termination of intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥18 years
- •At 2300h are deemed likely to board in the Emergency Department until 0700h the following morning, waiting for: Consultant assessments, investigations, transfers (including waiting for family members to drive them home in the morning)
排除标准
- •Previously included in this study
- •Engaged sleep research within the last month
- •Legally blind or history of hearing impairment.
- •Documented history of cognitive impairment
- •Delirious at initial assessment
- •Presenting complaint of head trauma
- •Admitted to an inpatient service
- •Poor English comprehension
结局指标
主要结局
Sleep Quality
时间窗: Measured following morning at approx. 0800h (up to 9hrs)
Richards Campbell Sleep Questionnaire
次要结局
- Patient satisfaction(Measured following morning at approx. 0800h (up to 9hrs))
- Perceived hours of sleep(Measured following morning at approx. 0800h (up to 9hrs))
- Heart Rate(Measured following morning at approx. 0800h (up to 9hrs))
- Delirium(Measured following morning at approx. 0800h (up to 9hrs))
- Individual domains of Richards Campbell Sleep Questionnaire(Measured following morning at approx. 0800h (up to 9hrs))
- Blood Pressure(Measured following morning at approx. 0800h (up to 9hrs))
- Changes in patient's overall sense of wellbeing(Measured following morning at approx. 0800h (up to 9hrs))
研究者
Stuart Douglas
Dr Stuart Douglas - PGY3 Emergency Medicine
Queen's University