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A comparison between smartphone usage and medication like midazolam to assess which is better in reducing preoperative anxiety in paediatric patients

A comparative evaluation of efficacy of smartphone based intervention v/s standard premedication using oral midazolam for preoperative anxiety in paediatric patients. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098625
Enrollment
60
Registered
2025-12-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: smartphone based intervention: To study anxiety using mYPAS-SF scale, quality of induction using icc score, peri operative hemp dynamic stability, parental anxiety using state trait anx

Sponsors

Pt. B.D Sharma, PGIMS, Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children between age 2-6 years which fall under American society of Anaesthesiology(ASA) physical status 1 and 2 posted for elective surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: Patient/guardian who refuses to give consent, child with history of any psychiatric illness, child with ongoing psychiatric medications, child with known intellectual disability, child with known severe visual and hearing impairment, child with previous anaesthetic exposure, child requiring emergency surgery.

Design outcomes

Primary

MeasureTime frame
Anxiety using mYPAS-SF scoreTimepoint: 1. A day before surgery during pre anaesthesia checkup 2. After entry in the preoperative room 3. During leaving preoperative room to operating room(30mins after the intervention) 4. Just before induction

Secondary

MeasureTime frame
Parental anxiety using STAITimepoint: Arrival in the preoperative holding room(P0), child leaving the preoperative room for operating room(P1)(that is 30mins after the intervention);Induction compliance using ICC (induction compliance checklist)scoreTimepoint: During induction;Hemodynamic parameters( heart rate, oxygen saturation, non invasive blood pressure)Timepoint: Day before surgery during Pre anaesthetic checkup(H0), after arrival in the holding area(H1), just before induction(H2), 1min after induction(H3), 5min after induction(H4)

Countries

India

Contacts

Public ContactVasudha Govil

Pt. B.D Sharma PGIMS Rohtak

dakshmalik315@gmail.com9466236862

Outcome results

None listed

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