title: A randomized-controlled trial of parent-led tactile stimulation to reduce pain during infant immunization injections.
abstract: OBJECTIVE
  To determine the effectiveness of parent-led tactile stimulation for pain reduction when added to a combination of evidence-based pain-reducing interventions in infants undergoing immunization injections.
  
  
  METHODS
  Healthy infants aged 4 to 6 months undergoing routine immunization at a primary care practice were eligible. Infants were randomized to tactile stimulation by a parent or usual care. Parents in the tactile stimulation group rubbed the ipsilateral thigh distal to the site for 15 seconds before, during, and after injections. In addition, all infants received evidence-based pain-relieving interventions including: sucrose solution, holding by a parent, and intramuscular injection without aspiration. The primary outcome was pain, measured by a validated tool, the Modified Behavioral Pain Scale (MBPS), by an observer unaware of treatment allocation using videotapes of the procedure. MBPS scores could range from 0 (no pain) to 10 (maximum pain). Parents, unaware of the study hypothesis, also rated infant pain in real time using a 100 mm visual analogue scale.
  
  
  RESULTS
  One hundred twenty infants participated. Infant characteristics did not differ (P>0.05) between the tactile stimulation and control groups. Mean MBPS scores and parent visual analogue scale scores did not differ between groups (8.2 [1.1] vs. 8.0 [1.3]; P=0.57) and (60 [20] vs. 53 [22] mm; P=0.10), respectively.
  
  
  CONCLUSIONS
  Parent-led tactile stimulation did not reduce pain in infants undergoing immunization injections when combined with other pain-relieving interventions. Potential reasons for the lack of effectiveness are discussed. Investigation of the effectiveness of clinician-led tactile stimulation in this population is recommended.
authors.affiliation: *Leslie Dan Faculty of Pharmacy, University of Toronto †Women's College Hospital Family Practice Health Centre ‡Department of Psychology, York University §Department of Psychiatry Research, Hospital for Sick Children ∥Toronto General Research Institute ¶Department of Anesthesia and Pain Management, University Health Network #Department of Child Health Evaluative Sciences, Pharmacy, Hospital for Sick Children, Toronto, ON, Canada.
authors.forename: Mary-Ellen
authors.initials: ME
authors.lastname: Hogan
authors.forename: Janet
authors.initials: J
authors.lastname: Probst
authors.forename: Karen
authors.initials: K
authors.lastname: Wong
authors.forename: Rebecca Pillai
authors.initials: RP
authors.lastname: Riddell
authors.forename: Joel
authors.initials: J
authors.lastname: Katz
authors.forename: Anna
authors.initials: A
authors.lastname: Taddio
mesh_terms: D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects* / Q000379:methods; D007223:Infant; D007267:Injections / Q000009:adverse effects* / Q000379:methods; D007273:Injections, Intramuscular; D007866:Leg; D008297:Male; D010146:Pain / Q000209:etiology*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D010290:Parents; D010812:Physical Stimulation / Q000379:methods; D013395:Sucrose; D013997:Time Factors; D014110:Touch; D016896:Treatment Outcome; D014741:Video Recording
chemical_list: D013395:Sucrose