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Assessment of pain perception in children during LA administration while active, passive and active-passive distraction

Comparative Evaluation of Active, Passive and Active- Passive Distraction Methods To Assess Pain Perception in Pediatric Patients Aged 4 to 8 Years During Administration Of Local Anaesthesia - A Randomised Double Blinded Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030286
Enrollment
108
Registered
2021-01-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: LA administration and assessing pain perception using FLACC scale.: Distracting tool will be provided, LA will be administered and pain perception will be recorded using FLACC scale, ch

Sponsors

Dr Sabreen Gujral
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 4-8 years 2. Presence of teeth with pulp involvement in which need of pulpal therapy necessitates the administration of local anaesthesia. 3. Co-operative patients (Franklââ?¬•s Behaviour Rating Scale ââ?¬â?? Positive + and Definitely Positive ++)

Exclusion criteria

Exclusion criteria: 1. Children with sensory disabilities 2. Previous experience with intraoral injections. 3. Allergy to Lignocaine Hydrochloride 4. History of systemic illness

Design outcomes

Primary

MeasureTime frame
To find a effective distraction technique for LA administration among VR glasses, softball compression or combination of both.The effectiveness will be measured using FLACC scale.The FLACC scale includes components of Face, Legs, Activity, Cry and Consolability. The primary outcome is to check if the given distraction tool is effectively distracting the child during LA administration which will be observed using the FLACC scale. Timepoint: Baseline—

Secondary

MeasureTime frame
To compare between active distraction (softball compression), passive distraction (VR eye glasses) and active-passive distraction (VR eye glasses and softball compression) method for LA administration. The secondary outcome includes assessing which group out of the three were effectively distracted with the tool they were provided with.Timepoint: Baseline—

Countries

India

Contacts

Public ContactDr Sabreen Gujral

MRIIRS

hindbhatia@gmail.com9811100192

Outcome results

None listed

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