Clinical trial NCT01826383: Improving Parental Soothing by Video
Official title: Improving Parental Soothing by Video: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Keywords: Infant
Immunization
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 128
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Infants must be 6 or 18 months old receiving a routine immunization injection.
* Parents must be fluent in English.
* Only one child per family can be enrolled.

Exclusion Criteria:

* No suspected developmental delays or chronic illnesses.
* Time spent in a Neonatal Intensive Care Unit.
* Born more than 3 weeks premature.

Primary outcomes:
measure: Modified Behaviour Pain Scale
timeFrame: 3 minutes post-last needle
Secondary outcomes:
measure: Measure of Adult and Infant Soothing and Distress
timeFrame: 3 minutes post-last needle
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dr. Saul Greenberg's Pediatric Clinic
state: Ontario
city: Toronto
country: Canada
facility: Dr. Hartley Garfield's Pediatric Clinic
state: Ontario
Study officials:
affiliation: York University
name: Rebecca R Pillai Riddell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taddio A, Nulman I, Koren BS, Stevens B, Koren G. A revised measure of acute pain in infants. J Pain Symptom Manage. 1995 Aug;10(6):456-63. doi: 10.1016/0885-3924(95)00058-7.
citation: Cohen, L.L., Bernard, R., McClellan, C., MacLaren, J. (2005). Assessing Medical Room Behaviour During Infants' Painful Procedures: The Measure of Adult and Infant Soothing and Distress (MAISD). Children's Health Care., 34, p. 81-94.