Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population

Overview

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.

Full Title of Study: “Efficacy of Distraction on Reduction of Procedural Pain Associated With Venipuncture in the Pediatric Post-Transplant Population”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 13, 2018

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.

Interventions

  • Other: Distraction
    • 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.

Arms, Groups and Cohorts

  • Experimental: Distraction
    • Patients 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.
  • No Intervention: Standard of care
    • Patients randomized to the “Standard of Care” group will not be provided with an iPad.

Clinical Trial Outcome Measures

Primary Measures

  • Faces Pain Scale – Revised (FPS-R)
    • Time Frame: 1 minute
    • 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.”

Secondary Measures

  • Observational Scale of Behavioral Distress – revised (OSBD-r)
    • Time Frame: 1 minute
    • OSBD-r is an observational measure of procedural distress. The behaviors assessed in the OSBD-r include cry, scream, restraint, verbal resistance, information seeking, emotional support, verbal pain and flail. Distress behaviors are weighted on a 1-4 point scale to reflect the intensity of distress. The higher scores indicated a greater level of distress.
  • Faces-Leg- Activity-Cry-Consolability (FLACC)
    • Time Frame: 1 minute
    • FLACC is an observational measure of procedural pain. Categories for scoring include Face, Legs, Activity, Cry, and Consolability. Total points assigned for each category may be from zero to ten. The numeric rating scale may be categorized into no pain, mild pain, moderate pain, and severe pain based on the 0 (representing no pain) -10 (severe pain) self-report scale.
  • Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS)
    • Time Frame: 1 minute
    • CHEOPS is an observational scale for evaluating postoperative pain in young children. It includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).

Participating in This Clinical Trial

Inclusion Criteria

  • History of solid organ transplantation – Undergoing venipuncture Exclusion Criteria:

  • Blood being drawn from a central line

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Columbia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Daniel S Tsze, MD, MPH, Assistant Professor of Pediatrics at the Columbia University Medical Center – Columbia University
  • Overall Official(s)
    • Daniel S Tsze, MD, MPH, Principal Investigator, Columbia University

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