A clinical trial to compare the effect of earplugs and eye masks with that of relaxing music on the sleep quality of critical patients

Not yet recruiting

Conditions: Other general symptoms and signs,

Registration Number: CTRI/2022/11/047210

Lead Sponsor: Safdarjung Hospital and Vardhman Mahavir Medical College New Delhi India

Brief Summary: This study is a Randomised Control Trial to compare earplugs and eye mask with relaxing music on sleep quality in critically ill patients. Subjective sleep quality will be assessed by a structured sleep quality scale based on Richard Campbell Sleep Questionairre in critically ill patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

1.Duration of stay in the ICU more than or equal to 48 hrs 2.Stable haemodynamics 3.Glasgow Coma Scale(GCS) more than or equal to 12 4.Ability to communicate and understand Hindi or English 5.Lucid and capable to understand questions.

Exclusion Criteria

1.Trauma/surgery to head, eyes, ears 2.Known psychiatric disease 3.Patients with hearing impairement/Vision impairement 4.Confusion, dementia, delirium at the time of admission 5.No sedative or narcotics in last 24 hrs 6.Baseline disturbed sleep pattern when patient was at home.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare earplugs and eye mask with relaxing music on sleep quality in critically ill patients using Richard Campbell Sleep Questionairre	The participants will be assessed for 2 days

Secondary Outcome Measures

Name	Time	Method
To compare earplugs and eye mask with relaxing music on:	1.Factors preventing sleep

Trial Locations

Locations (1): Safdarjung Hospital and Vardhman Mahavir Medical College
🇮🇳
Delhi, DELHI, India
Safdarjung Hospital and Vardhman Mahavir Medical College
🇮🇳Delhi, DELHI, India
Shikha Teny
Principal investigator
9131275807
shikhateny@gmail.com