A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization
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|ClinicalTrials.gov Identifier: NCT01601197|
Recruitment Status : Unknown
Verified October 2012 by Anna Taddio, University of Toronto.
Recruitment status was: Recruiting
First Posted : May 17, 2012
Last Update Posted : October 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy Infants Immunization Pain Management||Behavioral: Tactile stimulation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||May 2013|
Experimental: Tactile stimulation
Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s)
Behavioral: Tactile stimulation
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
No Intervention: No tactile stimulation
There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s)
- Infant Pain as assessed by the Modified Behavioral Pain Scale [ Time Frame: First 15 seconds after injection ]assessed from videotaped procedure
- Parent rating of infant pain using the Numerical Rating Scale [ Time Frame: first minute after injection ]
- Immunizer rating of infant pain using the Numerical Rating Scale [ Time Frame: first minute after injection ]
- Infant crying time [ Time Frame: duration of crying after injection ]assessed from videotaped procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601197
|Contact: Anna Taddio, PhDemail@example.com|
|Contact: Mary-Ellen Hogan, PharmDfirstname.lastname@example.org|
|Dr. Tommy Ho Pediatric Clinic||Recruiting|
|Toronto, Ontario, Canada, M5G 1Z6|
|Contact: Anna Taddio, PhD 416-978-8822 email@example.com|
|Contact: Mary-Ellen Hogan, PharmD 416-978-1466 firstname.lastname@example.org|
|Principal Investigator:||Anna Taddio, PhD||Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada|