Table 1.

Observations and Measurements

Outcome DomainsMeasureAssessment PeriodInformant
Anticipatory distress-ChildPrior experience VASEP
Global Mood ScaleEI*
−1 mI*
Pain-ChildObservational Scale of Behavioral Distress0I
Pain VAS:
 Linear+1 mI, N, P
 Faces+1 mI, N, P, C
Cry duration0I
Postprocedural distress-ChildGlobal Mood Scale+1 mI
+5 mI
Distress-ParentParental distress VAS+5 mP
Satisfaction-ParentComparison VAS+5 mP
Parental preference VAS+5 mP
Willingness to pay+5 mP
  • VAS indicates visual analog scale.

    Key for assessment period information is as follows: E, Enrollment in waiting room; −1 m, 1 minute before immunization administration; 0, during immunization administration; +1 m, 1 minute after immunization administration; +5 m, 5 minutes after immunization administration.

    Key for informant information is as follows: C, Child; I, Investigator, blinded; I

  • * , Investigator, nonblinded; N, Nurse; P, Parent.