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

July 12, 2017 updated by: Abhilasha Chaudhary, Maharishi Markendeswar University (Deemed to be University)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
eye mask administered from 10 pm to 7 am
Other: ocean sound
Ocean sound administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
Other: ear plug
ear plug administered from 10 pm to 7 am
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
eye mask administered from 10 pm to 7 am
Other: ocean sound
Ocean sound administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
Other: ear plug
ear plug administered from 10 pm to 7 am
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
eye mask administered from 10 pm to 7 am
Other: ocean sound
Ocean sound administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
Other: ear plug
ear plug administered from 10 pm to 7 am

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: 10-15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Principal Investigator: abhilasha chaudhary, M.Sc Nursing, Maharishi Markandeshwar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2015

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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