Can providing quiet time, ear plugs, eye masks and reducing noise and light in general medical wards improve the quality of sleep for patients?
| ISRCTN | ISRCTN15393303 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15393303 |
| Secondary identifying numbers | 2018-028 |
- Submission date
- 29/12/2018
- Registration date
- 19/02/2019
- Last edited
- 21/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Public
1307 Missouri Ave
St Louis
63104
United States of America
Study information
| Study design | Interventional non-randomised single-centre pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| 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 |
| 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(s) | Medstar Research Institute institutional review board, 01/07/2018, 2018-028 |
| 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 |
| 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 study start date | 02/01/2018 |
| Overall study end date | 01/10/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 190 |
| Total final enrolment | 215 |
| Participant inclusion criteria | 1. Aged 18 years or over 2. Admitted to general medical floor 3. Able to read and write in English |
| 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
Study participating centre
Baltimore
212225
United States of America
Sponsor information
Hospital/treatment centre
3001 South Hanover Street
Baltimore
21225
United States of America
"ROR" |
https://ror.org/05mdb5j94 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | Presented at the American Thoracic Society International Conference | 19/05/2019 | 21/09/2021 | No | No |
Editorial Notes
21/09/2021: The following changes have been made:
1. Abstract added.
2. The final enrolment number has been added from the abstract.
22/02/2019: Internal review.
