Improving Parental Soothing by Video

York University

Status: Completed

Conditions: Acute Pain

Treatments: Behavioral: Placebo Video; Behavioral: Active-Video

Study type: Interventional

Funder types: Other

Identifiers

NCT01826383

York HPRC 2013-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 5 to 20 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Active Video

Experimental group

Description:

This is a five-minute video that coaches parents about how to soothe their infant post-immunization.

Treatment:

Behavioral: Active-Video

Placebo Video

Placebo Comparator group

Description:

This is a video identical to that of the active video, except no specific instructions regarding how to soothe an infant post-immunization are given.

Treatment:

Behavioral: Placebo Video