Pain, Procedural Clinical Trial
Official title:
Efficacy of Distraction on Reduction of Procedural Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
Children with chronic diseases, particularly those who have received transplantation (e.g. cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as venipuncture multiple times per week. There is currently no standard of care for pain reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an outpatient. The study aims to determine the efficacy of distraction in reducing procedural pain and distress associated with venipuncture in pediatric post-transplant patients.
Children with chronic illnesses experience frequent painful experiences over extended periods
of time, and may develop long-term physiological, psychological and behavioral sequelae
including increased sensitivity to pain and higher levels of anxiety before painful
procedures. There is strong evidence to show that distraction is effective in reducing
children's pain and distress during painful procedures. However, the evidence to support
distraction, as well as other methods of pain reduction during venipuncture (i.e. vibration,
topical anesthetics, sucrose), has primarily focused on children who are previously well, as
those with chronic disease are an understudied population with regards to pain reduction
during simple procedures. Children with chronic disease or pathology, particularly those who
have received transplantation (e.g. cardiac, renal, liver), are a population who undergo
frequent painful procedures, such as venipuncture multiple times per week. There is currently
no standard of care for pain reduction during venipuncture for pediatric patients having
blood drawn in phlebotomy or in the transplant clinics as an outpatient.
The investigators will conduct a randomized control trial comparing two groups: Distraction
versus standard of care (i.e. no distraction). The intervention (distraction) will be
administered using an iPad and allowing the child to self-select a developmentally
appropriate distraction (e.g. game, movie, music). Participants will be videotaped for
approximately 1 minute, starting from the time of the venipuncture. This video will be viewed
at a later date by two trained study investigators to assess the patient's pain and distress
associated with venipuncture, as measured by the OSBD-r, CHEOPS, and FLACC.
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