Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
Efficacy of Distraction on Reduction of Procedural Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2016
CompletedFirst Posted
Study publicly available on registry
December 28, 2016
CompletedStudy Start
First participant enrolled
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2018
CompletedJune 3, 2025
May 1, 2025
1.1 years
December 23, 2016
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Faces Pain Scale - Revised (FPS-R)
Faces Pain Scale is a self-report measure of pain intensity developed for children. The scale is intended to measure how children feel inside. "0" equals "No pain" and "10" equals "Very much pain."
1 minute
Secondary Outcomes (3)
Observational Scale of Behavioral Distress - revised (OSBD-r)
1 minute
Faces-Leg- Activity-Cry-Consolability (FLACC)
1 minute
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
1 minute
Other Outcomes (3)
Time to successful venipuncture
Less than 5 minutes
Number of attempts necessary for successful blood draw.
Less than 5 minutes
Satisfaction evaluation
Less than 5 minutes
Study Arms (2)
Distraction
EXPERIMENTALPatients randomized to the "Distraction" group will be permitted to choose an age appropriate application (e.g. movie, game) which will be held for them during the blood draw.
Standard of care
NO INTERVENTIONPatients randomized to the "Standard of Care" group will not be provided with an iPad.
Interventions
Distraction will be provided by allowing the patient to will choose an age appropriate application (e.g. movie, game) which will be held for them during the blood draw.
Eligibility Criteria
You may qualify if:
- History of solid organ transplantation
- Undergoing venipuncture
You may not qualify if:
- Blood being drawn from a central line
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel S Tsze, MD, MPH
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics at the Columbia University Medical Center
Study Record Dates
First Submitted
December 23, 2016
First Posted
December 28, 2016
Study Start
May 10, 2017
Primary Completion
June 13, 2018
Study Completion
June 13, 2018
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share