The Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
NCT Number: NCT03774212
It is well established that patients sleep poorly in the Intensive Care Unit (ICU), and excessive noise is considered to be a modifiable cause of this. Previous studies have tried to reduce ambient noise by educating staff and fixing noisy equipment. Other studies have tried to reduce the noise experienced by patients by supplying them with active noise cancelling headphones and earplugs. In this study we are combining Active Noise Cancelling headphones with white noise to try and reduce noise experienced by patients, with the aim of improving their sleep. Sleep deprivation is known to negatively impact health, and so improving sleep may improve patient outcomes as well as improve the patient's experience in critical care.
The Investigators will screen all patients in the critical care wards in the Royal Infirmary of Edinburgh. Patients that are receiving ventilation, are delirious or have already been enrolled in the study will be excluded. After allowing patients to give informed consent, we will randomise them into one of two study groups:
Study group A will receive standard care on the 1st night (no headphones), and will receive the intervention (active noise cancelling headphones with white noise) on the 2nd night.
Study group B will receive the intervention on the 1st night, and will receive standard care on the 2nd night.
All patients will wear a Xiaomi MiBand 2 wrist band, that tracks movement and sleep.
Patients will fill in the Pittsburgh Sleep Quality Index at the beginning of the study to establish usual sleeping habits.
Our primary outcome measure is the mean score on the Richard Campbell Sleep Questionnaire (RCSQ), which will be filled in by the patient the morning after each night.
Our secondary outcome measure is the data from the wrist band, noise levels measured overnight, and patient experience of the intervention.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Edinburgh, EH16 4SA, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.
Other names: White noise masking
Time frame: Day 1 and day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Richards-Campbell sleep questionnaire is a series of 5 Visual analog scales that are 100mm long, and range from "best possible" to "worst possible". The final result is calculated by taking a mean of the distances along each line (from left to right).
Time frame: Day 2 after participant's enrolment. Completed throughout the 6 month study duration.
Patients will fill out a questionnaire about their experience. Participants will be required to circle an appropriate descriptive word to answer each question.
Time frame: Night 1 and 2 of participant's enrolment. Completed throughout the 6 month study duration.
The wrist band provides:
University of Edinburgh
Other
Do Active Noise Cancelling Headphones With White Noise Masking Improve Sleep in Non-ventilated, Non-delirious Critical Care Patients?
Acronym: SHH: Noise!
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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