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A study to assess the effect of maternal audio taped voice on selected clinical parameters of sedated children in PICU of AIIMS, New Delhi

A randomized controlled trial to assess the effect of maternal audio taped voice on selected clinical parameters of sedated children in PICU of AIIMS, New Delhi

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027378
Enrollment
60
Registered
2020-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Double blinding ,randomised controlled trial: 1.Mother of sedated children meeting the eligibility criteria will be requested to come to CMET facility 2.The maternal voice will be reco

Sponsors

AII INDIA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children who are sedated and have a sedation score of 17-26 as per Comfort Sedation scale, 2.Post neonatal age to 5 years 3.Whose mother is available and willing to record her voice

Exclusion criteria

Exclusion criteria: Sedated children with: 1.Documented h/o Hearing problem/Ear discharges. 2.Diagnosed with developmental delay or neurological diseases associated with symptoms of agitation 3.Increased intracranial pressure. 4.Uncontrolled seizure disorder and mental disorder 5.Children sedated with neuromuscular blockade like Atracurium 6.Extremely sick children. 7.Children with shock. Likely to stay less than 24hours in ICU

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of maternal audio taped voice on selected clinical parameters of sedated childrenTimepoint: twice a day (7-8am) to (5-6 pm)uptill 6 days

Secondary

MeasureTime frame
To compare the duration of ventilation period/ (sedation dose) in sedated children exposed vs. not exposed to maternal audio taped voice To compare the period of hospital stay in sedated children exposed vs. not exposed to maternal audio taped voice Timepoint: twice a day (7-8am) to (5-6 pm)uptill 6 days

Countries

India

Contacts

Public Contactshreelata Mandal

AIIMS New Delhi Ansari Nagar

levis.murry@gmail.com9319800810

Outcome results

None listed

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