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Effects of sleep enhancing methods in ICU patients

Effectiveness of Combination of Oral Melatonin with Non-Pharmacological Measures vs Non-Pharmacological measures alone on Quality of Sleep in critically ill Adult patients- Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074154
Enrollment
144
Registered
2024-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: GROUP I tablet melatonin 5mg hs: Oral melatonin 5mg hs + non-pharmacological measures like eye mask, ear plugs, ventilator to assist control in the night, decreased nursing care interve

Sponsors

AIIMS BHUBANESWAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult Patients who are expected to stay for more than 48hrs in ICU and ability to understand and communicate and able to receive their medications orally or through a nasogastric tube during the ICU stay

Exclusion criteria

Exclusion criteria: Renal failure (dialysis dependence), Liver failure (Child-Pugh class C), Patients who donâ??t have the ability to understand and communicate ?

Design outcomes

Primary

MeasureTime frame
To assess the difference in the quality of sleep in patients receiving oral melatonin 5mg along with non-pharmacological measures versus those receiving non pharmacological measures alone as measured by the mean Richards-Campbell Sleep Questionnaire scoreTimepoint: ICU admission to discharge or death or 14days of ICU stay whichever is earlier—

Secondary

MeasureTime frame
mean ICU length of stayTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death;Mean difference in number of good sleep days using RCSQ scoreTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death;Mean sleep hours measured with ActigraphyTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death ;Mean Cortisol level measured at 8AM (Alternate day)Timepoint: ICU admission to 14 days of ICU stay or till discharge or till death ;Incidence of delirium using CAM-ICU-7 ScoreTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death ;Mean patient ventilator daysTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death ;Re-intubation ratesTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death ;Mean consumption of SedativesTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death ;MortalityTimepoint: ICU admission to 14 days of ICU stay or till discharge or till death—

Countries

India

Contacts

Public ContactDr Alok Kumar Sahoo

All India Institute of Medical Sciences, Bhubaneswar

anaes_alok@aiimsbhubaneswar.edu.in9438884160

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026