FindTrial
Sign In

comparison of an anxiolytic drug versus playing with a smartphone to allay anxiety in children scheduled to undergo surgery

Comparison of midazolam versus smartphone based behavioural intervention for pre-operative anxiolysis in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014975
Enrollment
60
Registered
2018-07-19
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: null- children scheduled to undergo elective surgeries

Interventions

Intervention1: midazolam: midazolam 0.5mg/kg + oral paracetamol 15mg/kg Intervention2: smartphone intervention: smartphone intervention + oral paracetamol 15mg/kg Control Intervention1: placebo: oral

Sponsors

sree balaji medical college
Lead Sponsor
Sree Balaji Medical College
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: children posted for elective surgeries

Exclusion criteria

Exclusion criteria: 1. Children with developmental delay 2. Chromosomal disorders 3. Cerebral palsy 4. On anticonvulsant or other medications which may interfere with the study 5. Obesity 6. Parent refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
anxiety assessed by modified Yale pre-operative anxiety scaleTimepoint: Before intervention, 20min after intervention and after shifting to operating room—

Secondary

MeasureTime frame
post- operative anxietyTimepoint: 20- 30 min after shifting to post anaesthesia care unit—

Countries

India

Contacts

Public ContactVIDHYA N

Sree Balaji Medical College

vidhya2694@yahoo.com9597836540

Outcome results

None listed

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