Effectiveness of Ear Plug, Eye Mask and Ocean Sound on Sleep Quality Among ICU Patients

Sleep Quality Clinical Trial

Official title:

A Comparative Study to Assess the Effectiveness of Ear Plug, Eye Mask and Ocean Sound on Sleep Quality Among ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03215212
• Other study ID #: 770
• Status: Completed
• Phase: N/A
• First received: July 11, 2017
• Last updated: July 12, 2017
• Start date: November 30, 2015
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2017
• Source: Maharishi Markendeswar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the effectiveness of ear plug, eye mask and ocean sound on sleep quality among ICU patients. 60 patients were randomly allocated to group 1 and group 2 by lottery method i.e 30 in each group. Group 1 received earplugs and eye masks on the first night followed by washout period on second night and received ocean sound on third night, while the group 2 received ocean sound on the first night followed by washout period on second night and received earplugs and eye mask on third night.

Description:

a comparative study was done to assess the effectiveness of ear plug, eye mask and ocean sound on sleep quality.

Ear plug used in this study is a foam earplug made from polyurethane with noise reduction rating (NRR=29 dB, SNR=37dB). It is inserted into the ear canal to protect the user's ear from loud noise. The earplug used was manufactured by 3 M occupational health and environmental safety division company of India manufactured in Bengalaru560.Ear plug helps to reduce noise intensity which helps to decrease auditory perceptual processing.

Eye mask used in this study is a delicate dark colored cloth (black and blue) of fabric material, length -18.5 cm, width- 8.5cm, height- 30 millimeter filled with soft cushions like substance inside which cover both eyes and 2 elasticized strap that holds the mask on patients head which prevents incoming light away from patient's eyes and induces a state of pure darkness. The product detail of Eye mask was, model number-SM004 and was ordered from Amazon.Eye mask decreases the intensity of the light which enhances melatonin secretion (involve endocrine system). Additionally, eye mask helps to use of cognator subsystem as eye mask also helps to reduce visual perceptual processing.

Ocean sound is a type of white noise which is a soothing sound of waves crashing on the beach which is provided via ear phone for 30 min. It was delivered via the android application name relax melodies meditation of Ipnos software. Ocean sound is a type of white noise which prevents intense auditory stimuli less capable of stimulating the cerebral cortex during sleep which helps to decrease auditory perceptual processing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patients who are 18 or more than 18 years of age.

• Patients who were oriented to the time and individual.

• Patients who could understand and respond in Hindi/English.

• Patients having no history of head trauma.

• Patients having no mental diseases.

Exclusion Criteria:

• Patients having any trauma in head, ears, and eyes.

• Patients reporting discomfort with eye mask and ear plug.

• Patients who had a hearing deficit.

• Patients taking sleep inducing drugs like Narcotics, Sedatives.

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Other:
• eye mask
eye mask administered from 10 pm to 7 am
• ocean sound
Ocean sound administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
• ear plug
ear plug administered from 10 pm to 7 am

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University

References & Publications (4)

Daneshmandi M, Neiseh F, SadeghiShermeh M, Ebadi A. Effect of eye mask on sleep quality in patients with acute coronary syndrome. J Caring Sci. 2012 Aug 25;1(3):135-43. doi: 10.5681/jcs.2012.020. eCollection 2012 Sep. — View Citation

Patel M, Chipman J, Carlin BW, Shade D. Sleep in the intensive care unit setting. Crit Care Nurs Q. 2008 Oct-Dec;31(4):309-18; quiz 319-20. doi: 10.1097/01.CNQ.0000336816.89300.41. Review. — View Citation

Spencer JA, Moran DJ, Lee A, Talbert D. White noise and sleep induction. Arch Dis Child. 1990 Jan;65(1):135-7. — View Citation

Wallace CJ, Robins J, Alvord LS, Walker JM. The effect of earplugs on sleep measures during exposure to simulated intensive care unit noise. Am J Crit Care. 1999 Jul;8(4):210-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep quality	structured sleep quality scale Scores for each question ranges from 0 to 3, with higher scores indicating poor sleep quality and lower score indicating good sleep quality	10-15 minutes