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

Not Applicable

Completed

• Conditions: Sleep Quality
• Interventions: Other: eye mask; Other: ocean sound; Other: ear plug

• Registration Number: NCT03215212
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

Brief 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.

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 Timeline

• Study Start: 2015-11-30
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-07
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
earplug	ear plug	Ear plug made from polyurethane with (NRR= 29 db and SNR= 37 db) administered from 10 pm to 7 am.
eye mask	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.
ocean sound	ocean sound	Ocean sound a type of white noise administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
earplug	eye mask	Ear plug made from polyurethane with (NRR= 29 db and SNR= 37 db) administered from 10 pm to 7 am.
ocean sound	eye mask	Ocean sound a type of white noise administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
ocean sound	ear plug	Ocean sound a type of white noise administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
earplug	ocean sound	Ear plug made from polyurethane with (NRR= 29 db and SNR= 37 db) administered from 10 pm to 7 am.
eye mask	ocean sound	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.
eye mask	ear plug	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.

Primary Outcome Measures

Name	Time	Method
sleep quality	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