Improving Parental Soothing by Video
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      This study sets out to compare the effectiveness of a parent pain management coaching video
      that is 5-minutes in length. The investigators will be comparing an active-video to a
      placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month
      infants undergoing routine immunization. The investigators hypothesize the active video will
      result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase
      in the parental use of distraction, physical comfort, and rocking.
    

Detailed description: 
      Our goal is to determine if a video instructing parents on the principles of soothing their
      infant following immunization will influence soothing behaviours exhibited by parents, and
      pain reactivity and regulation in infants. We plan to present parents of young infants (6
      months) and older infants (18 months) with either a Treatment Video instructing them on the
      ABCD's (Assess Anxiety, Belly Breathe, Calm Close Cuddle, Distraction; Copyright R. Pillai
      Riddell) of pain management or a Placebo Video with neutral information. There is very
      minimal risk because our suggestions are based on what parents deemed 'sensitive' (in our
      ongoing longitudinal study) were doing naturally i.e., without any intervention in their
      day-to-day lives. Additionally, in a separate study, that already received ethics approval,
      parents viewed these videos without any negative side effects.

      Participants will be adult parents from one of two clinics in the Greater Toronto Area who
      bring their infant in for a routine immunization (12 or 18 months). In our cohort study
      (where we simply videotape dyads in the clinic).

      Parents will be asked to complete a brief questionnaire (Parent Information Sheet) entailing
      basic demographic information and preimmunization ratings of their worry about their infant's
      pain from the immunization. The parents will also be asked to complete the 18-item Brief
      Symptom Inventory (BSI-18) and the Negative Affect subscale (IBQ-R Very short form), in
      addition to demographic information. The parents will subsquently be asked to view a brief
      video (Treatment or Placebo Video) discussing the ABCD's of pain management described above.
      During the infant's routine immunization procedure the parents and infant will be videotaped
      for approximately 10 minutes, and the parent will be asked a few brief questions post
      immunization including ratings of their infant's pain from the immunization procedure and the
      helpfulness of the video.
    

Intervention name(s): Active-Video; Placebo Video
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This group will watch an active-video with pain management strategies for parents; This group will watch a placebo-video describing immunization generally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infant; Immunization