A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants

Abstract

Background: Clinician-led tactile stimulation (rubbing the skin adjacent to the injection site or applying pressure) has been demonstrated to reduce pain in children and adults undergoing vaccination.

Objective: To evaluate the analgesic effectiveness of clinician-led tactile stimulation in infants undergoing vaccination.

Methods: This was a partially blinded randomized controlled trial that included infants undergoing vaccination in a private clinic in Toronto. Infants were randomly allocated to tactile stimulation or no tactile stimulation immediately prior to, during, and after vaccination. The primary outcome was infant pain, assessed using a validated observational measure, the Modified Behavioral Pain Scale (MBPS; range = 0-10).

Results: Altogether, 121 infants participated (n = 62 tactile stimulation; n = 59 control); demographics did not differ (P > .05) between groups. MBPS scores did not differ between groups: mean = 7.2 (standard deviation = 2.4) versus 7.6 (1.9); P = .245.

Conclusion: Tactile stimulation cannot be recommended as a strategy to reduce vaccination pain in infants because of insufficient evidence of a benefit.

Trial registration: ClinicalTrials.gov NCT01601197.

Keywords: pain management; randomized controlled trial; tactile stimulation; vaccination.