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Comparison between Music interventions of Raga music and 528 Hz music with intravenous Midazolam to control agitation in patents on mechanical ventilation in an intensive care unit of a tertiary care hospital of India

Comparison of Music interventions (528 Hz music and Raga music) with intravenous Midazolam to control agitation in patents on mechanical ventilation: a randomized controlled trial in an intensive care unit of a tertiary care hospital of India - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089742
Enrollment
240
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services Health Condition 2: J962- Acute and chronic respiratory failure

Interventions

Intervention1: RAGA THERAPY AND 528Hz frequency music: The music interventions to be used will be a single session of Raga Ahir Bhairav (Group A) or 528 Hz music (Group F) to be played over a period o

Sponsors

Dr Nirnoy Das
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) Patients on day 2 to day 4 of mechanical ventilation [volume control ventilation: VCV mode] with oro-tracheal intubation between 18 to 70 years weighing 50 to 75 kgs (2) experiencing agitation on mechanical ventilation [RAAS +1 to +3]

Exclusion criteria

Exclusion criteria: (1) patient is extremely agitated posing a danger to healthcare providers [RASS +4] (2) patient already sedated [RASS below -1], delirious, with cognitive disabilities, decreased consciousness, comatose or brain dead (3) history of bilateral hearing loss (4) history of known psychiatric diseases or known addictions to psychoactive substances or opioids (5) patients with unstable haemodynamics (6) pregnant (7) trauma

Design outcomes

Primary

MeasureTime frame
PRIMARY AIM IS TO COMPARE THE EFFECTIVENESS OF 30 MINUTES OF INTERVENTION RAGA AHIR BHAIRAV MUSIC , 528HZ MUSIC ,SINGLE DOSE INTRAVENOUS MIDAZOLAM (0.05mg/kg) AND A PLACEBO INTERVENTION (USE OF HEADPHONES WITHOUT PLAYING ANY MUSIC) ON AGITATION AMONG MECHANICALY VENTILATED PATIENTS BY MEASURING RASS (RICHMOND AGITATION AND SEDATION SCALE)SCORETimepoint: ASSESMENT OF RASS (RICHMOND AGITATION AND SEDATION SCALE) SCORE BEFORE AND AFTER EACH INTERVENTION OF 30 MIN

Secondary

MeasureTime frame
To compare the effectiveness of 528 Hz music (30 minutes), Raga Ahir Bhairav music (30 minutes), single dose intravenous midazolam (0.05 mg/kg: for 50 to 75 kg patients) and a placebo intervention on heart rate (HR), systolic blood pressure (sBP), diastolic blood pressure (dBP), mean BP (MBP), respiratory rate (RR), oxygen saturation (SpO2), mean airway pressure and pain (measured by critical care pain observation tool). To compare the usage of rescue medicine [in form of intravenous fentanyl (1 microgram/ kg)] if any to control increased agitation [RASS +4], in the four groups.Timepoint: o compare the effectiveness of 528 Hz music (30 minutes), Raga Ahir Bhairav music (30 minutes), single dose intravenous midazolam (0.05 mg/kg) and a placebo intervention (use of headphones without playing any music) on agitation [measured by Richmond agitation and sedation scale: RASS] among patients on mechanical ventilation admitted in an ICU of a tertiary care hospital, Kolkata.

Countries

India

Contacts

Public ContactNIRNOY DAS

KPC MEDICAL COLLEGE AND HOSPITAL

nirnoydas@gmail.com09831781424

Outcome results

None listed

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