Acute Pain Clinical Trial
Official title:
Improving Parental Soothing by Video: A Randomized Controlled Trial
Verified date | April 2015 |
Source | York University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Months to 20 Months |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Dr. Hartley Garfield's Pediatric Clinic | Toronto | Ontario |
Canada | Dr. Saul Greenberg's Pediatric Clinic | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
York University |
Canada,
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.
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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