A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization

Study Overview
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Brief Summary
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Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.

Detailed Description
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Immunization injections are a significant source of pain for infants. At present, effective and feasible pain-relieving interventions include sugar water, fast injection without aspiration, and holding infants during the procedure. These methods, however, do not eliminate pain in all infants. Additional interventions are therefore needed. Tactile stimulation (rubbing/applying pressure) has been shown to reduce injection pain in children and adults, and may be a suitable intervention for infant injections. It is cost neutral, requires no preparation, and is easily incorporated into practice. The aim of this study is to determine the effectiveness of tactile stimulation when added to other proven analgesic interventions on reducing pain during infant immunization injections.

Official Title
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A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization

Conditions
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Healthy Infants, Immunization, Pain Management

Intervention / Treatment
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* Behavioral: Tactile stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto Exclusion Criteria: impaired neurological development history of seizure use of topical anesthetics use of sedatives or narcotics within 24 hours fever or illness that would prevent administration of vaccine prior participation in the trial

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tactile stimulation<br>Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s) | Behavioral: Tactile stimulation<br>* Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)<br>|
| No Intervention: No tactile stimulation<br>There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Pain as assessed by the Modified Behavioral Pain Scale | assessed from videotaped procedure | First 15 seconds after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent rating of infant pain using the Numerical Rating Scale |  | first minute after injection | 
| Immunizer rating of infant pain using the Numerical Rating Scale |  | first minute after injection | 
| Infant crying time | assessed from videotaped procedure | duration of crying after injection | 

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