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CompletedNCT03215212Updated Jul 14, 2017

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

An interventional study of eye mask and ocean sound in Sleep Quality, sponsored by Maharishi Markendeswar University (Deemed to be University). Completed. Per ClinicalTrials.gov, last updated 2017-07-14.

Sponsored by Maharishi Markendeswar University (Deemed to be University) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Nov 2015, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Sleep Quality

Keywords

  • ear plug
  • eye mask
  • ocean sound
  • sleep quality
  • intensive care unit
03

In context

Lead sponsor

Maharishi Markendeswar University (Deemed to be University) is the lead sponsor of 38 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    earplug

    Ear plug made from polyurethane with (NRR= 29 db and SNR= 37 db) administered from 10 pm to 7 am.

    Other: eye mask · Other: ocean sound · Other: ear plug

  • Experimental
    eye mask

    eye mask (18.5 cm, width 8.5cm, height -30mm )dark coloured cloth with 2 elasticised strap, covering both eyes administered from 10 pm to 7 am.

    Other: eye mask · Other: ocean sound · Other: ear plug

  • Experimental
    ocean sound

    Ocean sound a type of white noise administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm

    Other: eye mask · Other: ocean sound · Other: ear plug

Interventions

  • Othereye mask

    eye mask administered from 10 pm to 7 am

  • Otherocean sound

    Ocean sound administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm

  • Otherear plug

    ear plug administered from 10 pm to 7 am

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 10-15 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18815477 ↗
  • Spencer JA, Moran DJ, Lee A, Talbert D. White noise and sleep induction. Arch Dis Child. 1990 Jan;65(1):135-7. doi: 10.1136/adc.65.1.135. PubMed 2405784 ↗
  • 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. PubMed 10392220 ↗
  • 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. PubMed 25276688 ↗
  • Chaudhary A, Kumari V, Neetu N. Sleep Promotion among Critically Ill Patients: Earplugs/Eye Mask versus Ocean Sound-A Randomized Controlled Trial Study. Crit Care Res Pract. 2020 Dec 23;2020:8898172. doi: 10.1155/2020/8898172. eCollection 2020. PubMed 33425385 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03215212
Lead sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible party
Abhilasha Chaudhary (Student, M.sc Nursing, Maharishi Markendeswar University (Deemed to be University)) — Principal investigator
First posted
Jul 12, 2017
Start date
Nov 30, 2015
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jul 14, 2017

Study contacts

abhilasha chaudhary, M.Sc Nursing
principal investigator · Maharishi Markandeshwar University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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