The Effect of White and Pink Noise on Hospitalized Older Adults
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|ClinicalTrials.gov Identifier: NCT03485183|
Recruitment Status : Not yet recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Delirium in Old Age||Device: White/Pink Noise Other: Control Group||Not Applicable|
The purpose of this study is to determine if using an over-the-counter, commercially available sleep noise machine playing pink or white noise will reduce the incidence of delirium in hospitalized patients over the age of 65. Delirium is an acute change in cognition which commonly occurs in hospitalized older adults, and is linked with sleep-wake cycle disturbance. Delirium is associated with increased morbidity and mortality as well as longer hospital stays. This project will record Nursing Delirium Screening (Nu-DESC) scores for those receiving the intervention and comparing them to baseline data. Reducing delirium rates using a noninvasive, inexpensive method in a hospital setting could have a significant impact on patient outcomes and potentially reduce costs associated with longer hospital stays.
This protocol is based on two concepts. The first is that white/pink noise aids in promoting both sleep quality and quantity and the second is that poor sleep is associated with delirium. Therefore, it stands to reason that improving sleep may decrease the rate of delirium. It is well documented that the elderly are affected by delirium more than other demographics, therefore the benefits to this group would be the greatest in terms of decreasing morbidity and mortality.
White/pink noise was first described as a successful sleep intervention more than 30 years ago in a cardiac intensive care unit study. From that time to present there have been many studies that describe positive effects on sleep by noise machines as a single intervention, but typically they are bundled with other interventions such as earplugs and eye masks. Within the last 5 years, there has been a resurgence in the clinical study of white/pink noise on sleep quality and many of these studies use the gold standard of polysomnography, which employs many sensors to continuously monitor brain waves and sleep patterns. These studies also show a positive impact on both duration and quality of sleep.
More than 15 recent studies were identified that found a correlation between the sleep cycle and delirium. In these studies, sleep disturbance is present in the majority of patients with delirium. There is a clear link between sleep-wake cycle disturbance and delirium, but it is unclear whether an interrupted sleep-wake cycle causes delirium or vice versa. Despite the uncertainty, studies do show that sleep-enhancing interventions decrease rates of delirium and the duration of the delirium. The principal investigator would like to determine if white/pink noise can improve sleep quality and/or quantity, thereby decreasing the incidence of delirium.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be recruited for the intervention group and receive the intervention. Their data will be compared to baseline data--data without personal identifiers retrieved from chart review. These data will serve as the control group.|
|Masking:||None (Open Label)|
|Official Title:||The Effect of White and Pink Noise on Hospitalized Older Adults|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||October 2019|
Experimental: Intervention Group
The PI will set up the PicTek white/pink noise machine on the bedside table, and it will automatically turn on at 2200 and off at 0800 to the patient's preferred sound. The staff nurses will chart Nu-DESC scores every shift and as needed for change in mental status as is the current policy. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid.
Device: White/Pink Noise
White and/or pink noise will be played from 2200 to 0800 using the PicTek® white noise machine.
The PI will perform a chart review of patients who were admitted the month prior to the intervention being implemented. The PI will collect Nu-DESC scores for the duration of the participants' hospital stays, age, race, gender, presence of a dementia diagnosis, and use of a pharmacological sleep aid. These patients will receive the standard of care for delirium prevention.
Other: Control Group
Standard of care including lights on during the day and off at night, getting the patient out of bed for meals, presence of a large wall clock in the room, updating the whiteboard with current day, consistent reorientation of patient, geriatrician consults as needed, and pain management.
- Nursing Delirium Screening Scale (Nu-DESC) Score [ Time Frame: Collected every 12-hours shift and as needed for acute change in mental status from baseline through discharge for a minimum of 3 nights not to exceed 14 days. ]Nursing Delirium Screening Scale (Nu-DESC) scores, which are already routinely charted by staff nurses, will be collected after the PI sets up the white/pink noise intervention. A score of >2 is indicative of delirium.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485183
|Contact: Callie R Sullivan, BSN||(256) email@example.com|
|Contact: Latricia D Weed, PhD|
|United States, Alabama|
|UAB Highlands Hospital||Not yet recruiting|
|Birmingham, Alabama, United States, 35205|
|Contact: Callie R Sullivan, BSN 256-694-4399 firstname.lastname@example.org|
|Principal Investigator:||Latricia D Weed, PhD||Troy University|