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Clinical Trials/CTRI/2025/07/091838
CTRI/2025/07/091838Not yet recruitingPhase 4

Comparison of Toy Car, Video Display and Premedication in Reducing Preoperative Anxiety in Children Undergoing Elective Surgery- An Open Labelled Randomised Control Trial

All India Institute of Medical Sciences AIIMS Jodhpur1 site in 1 country132 target enrollmentStarted: August 6, 2025Last updated:
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Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
132
Locations
1
Primary Endpoint
The difference in anxiety scoring mYPAS-SF score when shifting to OR with Parental separation versus baseline
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
2.00 Year(s) to 7.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Pediatric patients belonging to the group of ASA I/II and in the age group of 2-7 years scheduled to undergo elective surgeries.

Exclusion Criteria

  • •ASA III/ IV
  • •Children undergoing emergency surgery
  • •Neuropsychiatry disease with delayed psychomotor development
  • •Onset or H/O sleep apnea or adenoid hypertrophy.

Outcomes

Primary Outcomes

The difference in anxiety scoring mYPAS-SF score when shifting to OR with Parental separation versus baseline

Time Frame: Baseline, Parental separation

Secondary Outcomes

  • Compare the difference in mYPAS-SF score when shifting to OR Table versus baseline (A2-A0), difference in mYPAS-SF when shifting to OR table versus at the time of parental separation ( A2-A1)(Baseline, Parental separation, While shifting to OR table)

Investigators

Sponsor
All India Institute of Medical Sciences AIIMS Jodhpur
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dhikshitha P

Department of Anaesthesiology and Critical Care Medicine

Study Sites (1)

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