Improving Parental Soothing by Video
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active-Video
Placebo Video
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Infant, Immunization
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.
Sites / Locations
- Dr. Saul Greenberg's Pediatric Clinic
- Dr. Hartley Garfield's Pediatric Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Video
Placebo Video
Arm Description
This is a five-minute video that coaches parents about how to soothe their infant post-immunization.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01826383
Brief Title
Improving Parental Soothing by Video
Official Title
Improving Parental Soothing by Video: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Infant, Immunization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Video
Arm Type
Experimental
Arm Description
This is a five-minute video that coaches parents about how to soothe their infant post-immunization.
Arm Title
Placebo Video
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Active-Video
Intervention Description
This group will watch an active-video with pain management strategies for parents
Intervention Type
Behavioral
Intervention Name(s)
Placebo Video
Intervention Description
This group will watch a placebo-video describing immunization generally.
Primary Outcome Measure Information:
Title
Modified Behaviour Pain Scale
Description
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)
Time Frame
3 minutes post-last needle
Secondary Outcome Measure Information:
Title
Measure of Adult and Infant Soothing and Distress
Description
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).
Time Frame
3 minutes post-last needle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
20 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca R Pillai Riddell, PhD
Organizational Affiliation
York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Saul Greenberg's Pediatric Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 3H1
Country
Canada
Facility Name
Dr. Hartley Garfield's Pediatric Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
7561228
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.
Results Reference
background
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.
Results Reference
background
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Improving Parental Soothing by Video
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