Condition category
Mental and Behavioural Disorders
Date applied
29/12/2018
Date assigned
19/02/2019
Last edited
22/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
36% of patients without a history of insomnia developed sleep problem in the hospital. In this study, we aimed to answer the question of whether reducing noise, light, providing quiet times, earplugs and eye masks for hospitalized patients could reduce the insomnia rate and severity at discharge.

Who can participate?
Adult patients who are admitted to the medical floors. We require that our patients must be English speakers who are able to read, to hear and to understand our questions in the survey to screen for insomnia.

What does the study involve?
All the patients consented to the study will be given earplugs and eye masks at the time of their admission. They are given instructions to use them and are advised to use ear plugs/eye masks during the day or at night if needed. Patients were also informed of routine labs and vital sign check time range in the hospital. During that month, patients will be provided quiet time from 4pm to 5pm and at night from 10:00 PM to 5AM. During quiet time, lights were dimmed down in the patients’ rooms and in the hallways. Televisions in patients’ rooms that are not in use were turned off. Nurses, physicians, physical therapists, medical assistants were encouraged not to speak loudly or interrupt patients sleep unless for emergency cases.

What are the possible benefits and risks of participating?
Benefits: there is no monetary compensation but patients will be provided with free earplugs and eye masks to take home. Risks: This study poses minimal risks to participants because it only includes giving out earplugs and eye masks, reducing light and noise. No treatment will be altered during the study period.

Where is the study run from?
Single center, Medstar Harbor hospital in Baltimore, Maryland, United States.

When is the study starting and how long is it expected to run for?
July 2018 to September 2018

Who is funding the study?
Self-paid by principal investigator.

Who is the main contact?
An Thi Nhat Ho, nhatan01@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr An Ho

ORCID ID

Contact details

1307 Missouri Ave
St Louis
63104
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2018-028

Study information

Scientific title

A pilot non-randomized control trial of providing quiet time, ear plugs, eye masks, reducing noise and light in improving sleep for patients in general medical wards

Acronym

Study hypothesis

Providing quiet time, earplugs, eye masks, reducing noise and light in general medical ward will decrease the rate of insomnia in hospitalized patients.

Ethics approval

Medstar Research Institute institutional review board, 01/07/2018, 2018-028

Study design

Interventional non-randomised single-centre pilot study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Insomnia

Intervention

All the patients consented to the study were given ear plugs and eye masks at the time of their admission. They are given verbal instructions to use them and were advised to use ear plugs/eye masks during the day or at night if needed. Patients were also informed of routine labs and vital sign check time range in the hospital. During that month, all the general medical wards in our hospital performed quiet time from 4pm to 5pm and at night from 10:00 PM to 5AM. During quiet time, lights were dimmed down in the patients’ rooms and in the hallways. Televisions in patients’ rooms that are not in use were turned off. Nurses, physicians, physical therapists, medical assistants were encouraged not to speak loudly or interrupt patients sleep unless for emergency cases. However, nurse driven protocols in our hospital to check on patient safety at night were still performed for both pre-intervention and intervention groups.

The research protocol during the research time was introduced to hospital employees during meeting sessions and by printed posters. Research staff also checked every day to maximize compliance with the protocol.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The frequency of insomnia will be determined using the percentage of patients with insomnia (ISI>7) at the time of discharge.

Secondary outcome measures

1. Insomnia severity will be determined using the ordinal score on the insomnia severity index at the time of discharge.
2. Patient satisfaction will be determined using the objective ordinal satisfaction score of the patients on the scale from 0 to 5 with 5 being the best hospital experience and duration of hospital stay.

Overall trial start date

02/01/2018

Overall trial end date

01/10/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Admitted to general medical floor
3. Able to read and write in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

1. Diagnosis of altered mental status
2. Dementia
3. Severe hearing deficit

Recruitment start date

15/07/2018

Recruitment end date

15/09/2018

Locations

Countries of recruitment

United States of America

Trial participating centre

Medstar Harbor Hospital
3001 South Hanover Street
Baltimore
212225
United States of America

Sponsor information

Organisation

Medstar Harbor Hospital

Sponsor details

3001 South Hanover Street
Baltimore
21225
United States of America

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: the datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

15/02/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/02/2019: Internal review.