The Effect of White and Pink Noise on Hospitalized Older Adults

NCT03485183 | Completed

• 1 other identifier: IRB-300001385
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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 delirium screening 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. It is anticipated that white/pink noise played at night will decrease rates of delirium in hospitalized older adults.

Conditions

Delirium in Old Age

Keywords

delirium; white noise; pink noise

Outcome Measures

Primary Outcomes (1)

• Nursing Delirium Screening Scale (Nu-DESC) Score

  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.

  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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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 0700 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

Control Group

OTHER

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

Interventions

White/Pink Noise DEVICE

White and/or pink noise will be played from 2200 to 0700 using the PicTek® white noise machine.

Intervention Group

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• English-speaking
• years of age or older
• have an estimated hospital stay of 3 or more nights
• have no known hearing deficits or wear hearing aids
• be free of delirium on admission
• be legally able to consent

You may not qualify if:

• non-English-speaking
• less than 65 years of age
• have known hearing deficits or wear hearing aids
• have delirium on admission
• cannot legally consent to participation
• transferred to/from the ICU before/during being enrolled in the study

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Highlands Hospital

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Latricia D Weed, PhD

  Troy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: October 1, 2018
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)