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

Comparison of earplugs and eye mask with relaxing music on sleep quality in critically ill patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047210
Enrollment
45
Registered
2022-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R688- Other general symptoms and signs

Interventions

Intervention1: Earplugs and eye mask: Group A participants will receive earplugs and eye mask and subjective sleep quality will be assessed by a stuctured sleep quality scale based on Richards Campbel

Sponsors

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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To compare earplugs and eye mask with relaxing music on sleep quality in critically ill patients using Richard Campbell Sleep QuestionairreTimepoint: The participants will be assessed for 2 days—

Secondary

MeasureTime frame
To compare earplugs and eye mask with relaxing music on: 1.Factors preventing sleep 2.Factors promoting sleep in critically ill patientsTimepoint: The participants will be assessed for 2 days—

Countries

India

Contacts

Public ContactVandana Talwar

Vardhman Mahavir Medical College and Safdarjung Hospital

drvandanatalwar@gmail.com9811352251

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026