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A study to assess the efficacy of a combined stimulation with mild vibration and cold at the skin site where vaccine will be administered in children who come for immunization

A randomized control trial to assess the efficacy of thermomechanical stimulation during vaccination on pain in pediatric patients attending the immunization clinic in a tertiary care centre

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016332
Enrollment
60
Registered
2018-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Thermomechanical stimulation & placebo: Vibration & cold stimulation for intervaention group & placebo for controlled group both concealed in similar looking device Intervention2: cold

Sponsors

Brinda P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: babies who visit to get immunized with pentavalent vaccine

Exclusion criteria

Exclusion criteria: sensitivity to cold,not accompanied by primary care giver,hungry & sick babies

Design outcomes

Primary

MeasureTime frame
Reduction of pain during and after the procedureTimepoint: 1min—

Secondary

MeasureTime frame
adherence to vaccination sheduleTimepoint: nil—

Countries

India

Contacts

Public ContactBrinda P

College of Nursing,AFMC,pune

rekhasadan@gmail.com9051432773

Outcome results

None listed

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