Background: Infant immunization pain is not currently well managed despite effective strategies. Objective: To determine the effectiveness of tactile stimulation when added to a combination of pain-reducing interventions in infants undergoing immunization. Methods: Healthy infants aged 4-6 months undergoing immunization in primary care were randomized to tactile stimulation or usual care. All infants also received pain-relieving interventions. A validated measure of acute pain in infants, the Modified Behavioral Pain Scale (MBPS), was the primary outcome. Results: Altogether, 120 infants participated. Characteristics did not differ (p > 0.05) between those allocated to tactile stimulation and usual care groups. Mean MBPS pain scores did not differ between groups: 8.2 (1.1) vs. 8.0 (1.3); p = 0.57, respectively. Conclusions: Parent-led tactile stimulation did not improve pain relief in infants when added to other interventions. Parental attention could have been focused on tactile stimulation, preventing parents from performing appropriate soothing activities. Additional investigation of the effectiveness of clinician-led tactile stimulation is recommended.

Background: Infant immunization pain is not currently well managed despite effective strategies. Objective: To determine the effectiveness of tactile stimulation when added to a combination of pain-reducing interventions in infants undergoing immunization. Methods: Healthy infants aged 4-6 months undergoing immunization in primary care were randomized to tactile stimulation or usual care. All infants also received pain-relieving interventions. A validated measure of acute pain in infants, the Modified Behavioral Pain Scale (MBPS), was the primary outcome. Results: Altogether, 120 infants participated. Characteristics did not differ (p > 0.05) between those allocated to tactile stimulation and usual care groups. Mean MBPS pain scores did not differ between groups: 8.2 (1.1) vs. 8.0 (1.3); p = 0.57, respectively. Conclusions: Parent-led tactile stimulation did not improve pain relief in infants when added to other interventions. Parental attention could have been focused on tactile stimulation, preventing parents from performing appropriate soothing activities. Additional investigation of the effectiveness of clinician-led tactile stimulation is recommended.