Improving Parental Soothing by Video

Improving Parental Soothing by Video: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Behavioral: Active-Video; Behavioral: Placebo Video

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4P 3H1
      • Dr. Saul Greenberg's Pediatric Clinic
    • Toronto, Ontario, Canada, M5G 1N8
      • Dr. Hartley Garfield's Pediatric Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Video; This is a five-minute video that coaches parents about how to soothe their infant post-immunization.	Behavioral: Active-Video; This group will watch an active-video with pain management strategies for parents
Placebo Comparator: Placebo Video; 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.	Behavioral: Placebo Video; This group will watch a placebo-video describing immunization generally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Behaviour Pain Scale	Infant pain regulation was operationalized using The Modified Behaviour Pain Scale (MBPS), modified by Taddio et al. (1995) for use with infants during office procedures. The measure rates the severity of distress reflected in three types of infant pain behaviours: (1) facial expressions; (2) cry; and (3) body movements during 15-second epochs post-immunization (for 3 minutes). Infants are assigned a score from 0 to 3 (or 0 to 4 on the cry scale), with larger values indicating a more intense behavioural response (Total Range 0-10)	3 minutes post-last needle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Adult and Infant Soothing and Distress	The MAISD (Measure of Adult and Infant Soothing and Distress; Cohen et al., 2005) is a behavior observation scale that was developed to examine the discrete behaviors exhibited by parents during children's invasive medical procedures. Rather than attempting to examine all behaviors, only those that were viewed as being potentially impacted by the treatment video will be included. Thus, distraction, rocking, physical comfort were selected. Each behaviour is coded every 5 seconds for either presence or absence (0 or 1). Three separate scores will be derived for each behaviour (distraction, rocking, physical comfort).	3 minutes post-last needle

Collaborators and Investigators

• Sponsor: York University
• Investigators: Principal Investigator: Rebecca R Pillai Riddell, PhD, York University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Infant; Immunization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: York HPRC 2013-004