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Study the effect of Music therapy & noise cancellation in PICU patient

Study of the effect of Music & Noise cancellation as an adjuvant therapy for sedation in a mechanically ventilated patient in PICU : a multiarm parallel group randomised open labelled controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053914
Enrollment
225
Registered
2023-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: F439- Reaction to severe stress, unspecified

Interventions

Intervention1: Study the effect of music therapy and noise cancellation in mechanically ventillated patient, for sedation requirements to: 3 groups are made one given music therapy other receive noise

Sponsors

Dr Mrunal kamble
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: all patients admitted in PICU AND RECEIVING INVASIVE MECHANICAL VENTILATION FOR >24 HRA WITHIN 48 HRS OF ADMISSION

Exclusion criteria

Exclusion criteria: 1) ill patient with end of life care is expected 2) Patient seriously with known hearing deficit 3)Parents declining consent 4) Traumatic brain injury 5) infant 12 years 6) Patients requiring continuse infusion of paralytic agents 7) Patients not on any sedatives after ventilation

Design outcomes

Primary

MeasureTime frame
1.comfort behaviour SCALE score 2.CHANGE IN VITAL SIGNS BEFORE AND DURING INTERVENTION 3.FEASIBILITY OF MUSIC TRIAL IN PICU Timepoint: AT THE START AND END OF EACH INTERVENTION 3 TIMES A DAY FOR 7 DAYS OF THERAPY OR TILL MECHANICAL VENTILATION.

Secondary

MeasureTime frame
To study the changes in heart rate, respiratory rate, systolic B.P., diastolic B.P., & Oxygen saturation before, during, and after the music & Noise cancellation therapy. 2. To assess the feasibility of Music & Noise cancellation therapy in mechanically ventilated PICU Patients. 3.To assess the length of Mechanical ventilation(Hrs ) and PICU stay(days) in both groupsTimepoint: AT THE START AND END OF 7 DAYS OF THERAPY

Countries

India

Contacts

Public ContactDR MRUNAL KAMBLE

Government Medical College Aurangabad

SMITA.MUNDADA@gmail.com9224287215

Outcome results

None listed

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