Effect of use of combination of ear plugs, eye mask and a drug called melatonin in icu patients to prevent sleep disturbances and mental disturbances.

Effect of combination of melatonin with non pharmacological strategies on delirium prevention in ICU- a randomised controlled trial - N/A

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061285

Enrollment

Registered

2024-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: A00-B99- Certain infectious and parasitic diseases Health Condition 2: I00-I99- Diseases of the circulatory system Health Condition 3: N00-N99- Diseases of the genitourinary system Health Condition 4: J00-J99- Diseases of the respiratory system Health Condition 5: L00-L99- Diseases of the skin and subcutaneous tissue Health Condition 6: E00-E89- Endocrine, nutritional and metabolic diseases Health Condition 7: S00-T88- Injury, poisoning and certain other consequences of exter

Interventions

Intervention1: tablet melatonin 3mg orally ear plugs eye mask: before sleeping, patients will be made to take tablet melatonin 3mg orally with sips of water at 9pm and ear plugs and eye mask will b

Eligibility

Inclusion criteria

Inclusion criteria: 1 adults admitted to icu expected to stay for more than 24 hours 2 ability of patients to understand and communicate 3 patients should be enrolled within 24 hours of ICU admission

Exclusion criteria

Exclusion criteria: invasive ventilation altered sensorium or psychiatric illness or seizure or sleep apnoea hearing or vision impairment pregnancy and breast feeding nil bh mouth hepatic impairment or liver transplant history of substance abuse severe heart failure or hypotension hight blood sugar already on melatonin therapy or drug allergy to melatonin

Design outcomes

Primary

Measure	Time frame
occurrence of delirium in ICU patients 1 incidence of delirium 2 duration of deliriumTimepoint: CAM ICU will be assessed at 8am 2pm and 8pm everyday for 3 consecutive days in both groups	—

Secondary

Measure	Time frame
compliance and comfort of ear plugs and eye maskTimepoint: ease of use, effectiveness and comfort shall be assessed at 8am for 3 consecutive days;indirect markers of delirium severityTimepoint: need for antipsychotic or sedation or physical restraints or participation in physiotherapy sessions or patient removal of IV lines or catheters shall be assessed daily for 3 consecutive days;length of stay in icu or hospital and impact on outcomeTimepoint: till discharge from icu or hospital;sleep quality assessment by Richards Campbell sleep questionnaireTimepoint: sleep questionnaire shall be answered everyday in the morning at 8am for 3 consecutive days	—

Measure

Time frame

compliance and comfort of ear plugs and eye maskTimepoint: ease of use, effectiveness and comfort shall be assessed at 8am for 3 consecutive days;indirect markers of delirium severityTimepoint: need for antipsychotic or sedation or physical restraints or participation in physiotherapy sessions or patient removal of IV lines or catheters shall be assessed daily for 3 consecutive days;length of stay in icu or hospital and impact on outcomeTimepoint: till discharge from icu or hospital;sleep quality assessment by Richards Campbell sleep questionnaireTimepoint: sleep questionnaire shall be answered everyday in the morning at 8am for 3 consecutive days

—

Countries

India

Contacts

Public ContactDr. Ankhitha R S

Narayana hrudayalaya Surgical hospital mysore

naveen.s.dr@narayanahealth.org9448922780

Outcome results

None listed

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