Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tactile stimulation | Experimental | Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s) |
|
| No tactile stimulation | No Intervention | There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tactile stimulation | Behavioral | Immunizer will rub the ipsilateral limb before, during and after immunization injection(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant Pain as assessed by the Modified Behavioral Pain Scale | assessed from videotaped procedure | First 15 seconds after injection |
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Taddio, PhD | Contact | 416-978-8822 | anna.taddio@utoronto.ca | |
| Mary-Ellen Hogan, PharmD | Contact | 416-978-1466 | me.hogan@utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Tommy Ho Pediatric Clinic | Recruiting | Toronto | Ontario | M5G 1Z6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24634424 | Derived | Taddio A, Ho T, Vyas C, Thivakaran S, Jamal A, Ilersich AF, Hogan ME, Shah V. A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants. Clin Pediatr (Phila). 2014 Jun;53(7):639-44. doi: 10.1177/0009922814526976. Epub 2014 Mar 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Infant crying time |
assessed from videotaped procedure |
| duration of crying after injection |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |