NCT03215212

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

July 11, 2017

Last Update Submit

July 12, 2017

Conditions

Sleep Quality

Keywords

ear plugeye maskocean soundsleep qualityintensive care unit

Outcome Measures

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

    10-15 minutes

Study Arms (3)

earplug

EXPERIMENTAL

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

Other: eye maskOther: ocean soundOther: ear plug

eye mask

EXPERIMENTAL

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 maskOther: ocean soundOther: ear plug

ocean sound

EXPERIMENTAL

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

Other: eye maskOther: ocean soundOther: ear plug

Interventions

eye maskOTHER

eye mask administered from 10 pm to 7 am

earplugeye maskocean sound
ocean soundOTHER

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

earplugeye maskocean sound
ear plugOTHER

ear plug administered from 10 pm to 7 am

earplugeye maskocean sound

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 18815477BACKGROUND

  • 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.

    PMID: 2405784BACKGROUND

  • 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.

    PMID: 10392220BACKGROUND

  • 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.

    PMID: 25276688RESULT

  • 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.

    PMID: 33425385DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesProtective ClothingClothingManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • abhilasha chaudhary, M.Sc Nursing

    Maharishi Markandeshwar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student, M.sc Nursing

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 12, 2017

Study Start

November 30, 2015

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share