Completed

Improving Parental Soothing by Video: A Randomized Controlled Trial

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What is being tested

Active-Video

+ Placebo Video

Behavioral
Who is being recruted

Neurologic Manifestations+2

+ Pain

+ Signs and Symptoms

From 5 to 20 Months
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorYork University
Last updated: April 14, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorYork University
Last updated: April 14, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

128 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 20 Months

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsAcute Pain

Criteria

3 inclusion criteria required to participate
Infants must be 6 or 18 months old receiving a routine immunization injection

Only one child per family can be enrolled

Parents must be fluent in English

3 exclusion criteria prevent from participating
Born more than 3 weeks premature

No suspected developmental delays or chronic illnesses

Time spent in a Neonatal Intensive Care Unit

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Dr. Saul Greenberg's Pediatric Clinic

Toronto, CanadaOpen Dr. Saul Greenberg's Pediatric Clinic in Google Maps

Dr. Hartley Garfield's Pediatric Clinic

Toronto, Canada
Completed2 Study Centers