MedPath

To assess the effect of sedative drug and toys on anxiety in children

Phase 4
Completed
Conditions
posted for elective surgeries
Registration Number
CTRI/2018/03/012863
Lead Sponsor
msramaiah medical college and hospitals
Brief Summary

Allchildren fulfilling the inclusion criteria will be visited on the preoperative day for pre anaesthetic evaluationby a consultant or resident who will anaesthetize the child next day. Childrenin the behavioral intervention group will be given a basket of toys. They willbe allowed to select toy of their choice. They will also be given circuits andmasks for familiarization. They will be thought how to breathe through thecircuit. Children in the midazolam group will not be given any toys after preanesthetic evaluation. Intravenous line will be placed for all children in thewards.

Onthe day of surgery after the children are shifted to pre anaesthetic areamodified yale pre operative anxiety scale (mYPAS) Appendix 1 will be recordedin both the groups. Children in behavioral intervention group will be giventoys and allowed to play with them. Children in the midazolam group willreceive intravenous midazolam 0.1mg/kg. After 10 mins mYPAS score will berecorded in both the groups and the children will be shifted to operationtheater. The last mYPAS score will be recorded just before induction ofanaesthesia.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
64
Inclusion Criteria

children between 3 to 9 years of ASA 1 and 2 posted for elective minor surgeries.

Exclusion Criteria

children below 3 years and above 9 years.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the efficacy of behavioral intervention program by giving toys and the effects with premedication with intravenous midazolam reduce anxiety in children preoperatively10 minutes and 20 minutes after intervention
Secondary Outcome Measures
NameTimeMethod
postoperative sedation10 minutes after surgery

Trial Locations

Locations (1)

Department of anesthesiology

🇮🇳

Bangalore, KARNATAKA, India

Department of anesthesiology
🇮🇳Bangalore, KARNATAKA, India
Dr Sandya Rani D C
Principal investigator
9886127243
drsandyarani@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.