Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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Reducing Pain in Four- to Six-month Old Infants Undergoing Immunization Using a Multi-modal Approach

Conditions
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Pain From Immunization

Intervention / Treatment
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* Behavioral: Tactile stimulation added to Standard care
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy infants 4 to 6 months old routine immunization with DTaP-IPV-Hib and PCV Exclusion Criteria: impaired neurological development history of seizure use of topical local anaesthetics at the injection site use of sedatives or narcotics in the preceding 24 hours fever or illness that would prevent administration of the vaccine parent is unable to use the assessment tools in the study parent does not speak English prior participation in this trial

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br> | Behavioral: Standard care<br>* Fast injection technique without aspiration. Oral sucrose 2 minutes before first injection. Parent holds infant close.<br>|
| Experimental: Tactile stimulation<br> | Behavioral: Tactile stimulation added to Standard care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response to immunization, as measured by the Modified Behavioral Pain Scale (MBPS). |  | at time of injection on day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain response to immunization as measured by observer Visual Analogue Scale (VAS). |  | at time of injection on day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tactile stimulation, pain, immunization, infant