An interventional study of Tactile stimulation added to Standard care and Standard care in Pain From Immunization, sponsored by Women's College Hospital. Completed at 1 site in Canada. Open to participants aged 4 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-01.
Sponsored by Women's College Hospital · Not applicable, Interventional, and Treatment
The aim of this study is to answer the following question: In healthy infants aged four to six months undergoing routine immunization for diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type B (DTaP-IPV-Hib) and pneumococcal conjugate vaccine (PCV) while receiving a combination of proven analgesic interventions (least painful injection technique, holding by parent, and oral sucrose solution) and non-procedural talk by the parent, does the addition of rubbing near the site of injection reduce pain as measured by the Modified Behavioral Pain Scale (MBPS) to a greater extent than no rubbing?
Immunization is a significant source of pain and distress for infants. At present pain-relieving interventions are rarely employed to manage this pain.
There are many non-pharmacological methods that can be used to reduce immunization pain. These include: sugar water, fast injection without aspiration, holding infants during the procedure, and non-procedural related parental behaviours such as distraction. At present, there are no studies of tactile stimulation during noxious procedures in infants and its effectiveness, therefore, is unclear. Light rubbing of the skin near the injection site that is administered by a parent immediately before, during and immediately after immunization is an easily learned, cost neutral intervention that could offer improved pain management.
Women's College Hospital is the lead sponsor of 83 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Standard care
Behavioral: Tactile stimulation added to Standard care
* Parent rubs the infant's skin near the injection site just before, during and after the injection. * Fast injection technique without aspiration. * Oral sucrose 2 minutes before first injection. * Parent holds infant close.
* Fast injection technique without aspiration. * Oral sucrose 2 minutes before first injection. * Parent holds infant close.
Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS).
Time frame: at time of injection on day 1
Pain response to immunization as measured by observer Visual Analogue Scale (VAS).
Time frame: at time of injection on day 1
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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