NCT01826383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

April 3, 2013

Last Update Submit

April 13, 2015

Conditions

Acute Pain

Keywords

InfantImmunization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Measure of Adult and Infant Soothing and Distress

    3 minutes post-last needle

Study Arms (2)

Active Video

EXPERIMENTAL

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

Behavioral: Active-Video

Placebo Video

PLACEBO COMPARATOR

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

Interventions

Active-VideoBEHAVIORAL

This group will watch an active-video with pain management strategies for parents

Active Video
Placebo VideoBEHAVIORAL

This group will watch a placebo-video describing immunization generally.

Placebo Video

Eligibility Criteria

Age5 Months - 20 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Saul Greenberg's Pediatric Clinic

Toronto, Ontario, M4P 3H1, Canada

Location

Dr. Hartley Garfield's Pediatric Clinic

Toronto, Ontario, M5G 1N8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 7561228BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Exergaming

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rebecca R Pillai Riddell, PhD

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 8, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

CA(2)