SleepSure: A Randomised Controlled Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 主要终点
- SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.
研究概览
简要总结
The aim of this study is to determine whether routinely providing patients admitted to hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients having a better quality of sleep and/or longer, more satisfying sleep.
详细描述
This is a prospective, investigator blinded, randomised controlled study involving all patients admitted to any of ten acute wards in a large, busy hospital serving both the local population of about 700,000 people and a wider area for specialist services.
Patients will be identified at the time of admission and recruited as soon as possible by nursing and medical staff involved in the admission process. The primary exclusion criterion is some obvious reason that using the equipment is not possible (e.g. allergy to materials used).
After gaining consent, from the patient, or assent from a relative if the person is unable to consent at the time, the patient will be registered and allocated a number. Each ward will have prefilled envelopes with a randomly determined group allocation within it, and after registration this will be opened to determine the patient's group. Each patient will be given a short information leaflet and consent form.
Patients allocated to the intervention will be given the ear plugs and eye mask (in a plastic wallet, with instructions) and will be informed about their use.
On the next morning (i.e. after the first night in hospital) the patient will be approached and asked if he or she agrees to provide outcome information. Specifically patients who were unable to give consent initially (or do not recall doing so) will have the project explained again.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age.
- •Be expected to stay in Oxford University Hospitals National Health Service (NHS) Foundation Trust for at least one night.
- •Be able to understand and use earplugs and eye mask.
- •Have basic understanding of English reading and writing.
- •Be considered likely to have the Mental Capacity to give consent for use of personal data in the study at the point of filling in the SleepSure Questionnaire (time of discharge). Data will not be collected from individuals who are unable to give consent with the filling in of the SleepSure questionnaire.
- •Be expected to be able to fill in the SleepSure Questionnaire at the point of discharge with or without assistance.
排除标准
- •They have or are expected to have an obvious medical contra-indication to the use of earplugs and eye mask at the point of enrollment e.g. eye infection, as per clinical judgement of recruiter.
- •They are unlikely to benefit from the intervention in the judgement of the recruiter (i.e. individuals who are deaf and blind).
研究组 & 干预措施
Control
Patients in this arm will continue current standard management for sleep, which is largely reactive; if a patient requests night sedation or complains that they cannot sleep and that they want help, then zopiclone is prescribed, starting at 3.75 mg.
干预措施: Zopiclone (Drug)
Eye mask and ear plugs
General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment.
干预措施: Ear plugs (Device)
Eye mask and ear plugs
General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment.
干预措施: Eye Mask (Device)
Eye mask and ear plugs
General management will be as for the control group. In addition, patients in this group will be given ear plugs and eye shades (masks) to use when trying to sleep. The patient will generally be responsible for using or not using the equipment, though ward nurses may remind patients if they notice that the patient has the equipment.
干预措施: Zopiclone (Drug)
结局指标
主要结局
SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.
时间窗: At end of first night in hospital after recruitment (i.e. the next morning)
SleepSure is a short questionnaire which asks the patient to rate their sleep using a 1-10 numerical rating scale for eight items covering the quality of their sleep (e.g. difficulty getting to sleep, interruptions). Two additional questions recorded the use of aids. It takes no more that 2-3 minutes to complete. The eight numerical rating scores are summed and divided by 8 to give a score from 1 (very good sleep) to 10 (very poor sleep).
次要结局
- Use of Zopiclone (Night Sedation)(From date of admission to date of discharge, up to 90 days)
- Length of Stay(From date of admission to date of discharge, up to 90 days)
- Number of Falls(From date of admission to date of discharge, up to 90 days)
研究者
Adam Monk
Principle Investigator
Oxford University Hospitals NHS Trust