Clinical trial NCT03004456: Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
Official title: Efficacy of Distraction on Reduction of Procedural Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Procedural
Distress, Procedural
Venipuncture
Keywords: Phlebotomy
Pain
Distress
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* History of solid organ transplantation
* Undergoing venipuncture

Exclusion Criteria:

* Blood being drawn from a central line

Primary outcomes:
measure: Faces Pain Scale - Revised (FPS-R)
timeFrame: 1 minute
Secondary outcomes:
measure: Observational Scale of Behavioral Distress - revised (OSBD-r)
timeFrame: 1 minute
measure: Faces-Leg- Activity-Cry-Consolability (FLACC)
timeFrame: 1 minute
measure: Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
timeFrame: 1 minute
Other outcomes:
measure: Time to successful venipuncture
timeFrame: Less than 5 minutes
measure: Number of attempts necessary for successful blood draw.
timeFrame: Less than 5 minutes
measure: Satisfaction evaluation
timeFrame: Less than 5 minutes
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Daniel S Tsze, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: