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A comparative study on video distraction with or without intranasal dexmeditomedine on parental separation anxiety in children aged 2 to 6 years undergoing surgery under general anaesthesia

A comparative study on video distraction with or without intranasal dexmedetomidine on parental separation anxiety in children aged 2 to 6 years undergoing surgery under general anaesthesia. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103503
Enrollment
150
Registered
2026-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Video distraction with or without intranasal dexmeditomedine: Group V : Video distraction Video of childs choice started 20 minutes before shifting to the OT and continued through mask

Sponsors

Sir SunderLal Hospital IMS BHU Varanasi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged 2 to 6 years under ASA Physical Status I or II 2.scheduled for elective surgery under general Anesthesia 3. duration of surgery is expected up to 120 minutes. 4.Accompanied by a parent or legal guardian who consents to participate. 5.Able to watch and respond to video content (developmentally appropriate for age).

Exclusion criteria

Exclusion criteria: 1.Children with neurological disorders, developmental delay, or psychiatric illness. 2.Children with visual or hearing impairments preventing effective video distraction 3.Known allergy or hypersensitivity to dexmedetomidine. 4.Children on chronic sedatives, anticonvulsants, or other medications affecting the central nervous system. 5.History of upper respiratory tract infection. 6.Presence of cardiac conduction abnormalities, bradycardia, or hypotension. 7.Emergency surgeries or procedures. 8.Children with nasal obstruction, deformity, or active nasal infection that may interfere with intranasal drug administration. 9.Recent use of sedative. 10.Parents / Guardian not allowing mobile phone.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of video distraction alone or with intranasal dexmeditomedine on separation anxiety will be measured by using Modified Yale Preoperative Anxiety Scale (mYPAS) in different time points.Timepoint: T0 - In holding area T1- Just before shifting to OT after intervention T2 - In OT before induction.

Secondary

MeasureTime frame
Mask acceptance during induction Ease of separation Hemodynamics HR, BP, RR Emergence delirium Parental satisfaction (0-10) by VAS Adverse events - Hypoxia, BradycardiaTimepoint: T3-Mask compliance measurement Preoperative Before intubation After intubation 0 mins 15 mins 30 mins 45 mins 60 mins 75 mins 90 mins 105 mins 120 mins

Countries

India

Contacts

Public ContactDr Akash

IMS BHU VARANASI

bhuapsingh@gmail.com9794855871

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026