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Completed

NCT Number: NCT03004456

Distraction for Reduction of 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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of solid organ transplantation
  • Undergoing venipuncture

Exclusion criteria

  • Blood being drawn from a central line

Treatment and study plan

Distraction

Other

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.

Other names: iPad

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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).

Other outcomes

  1. Time to successful venipuncture

    Time frame: Less than 5 minutes

    Defined as the time from placing of tourniquet to completion of collection of the first tube.

  2. Number of attempts necessary for successful blood draw.

    Time frame: Less than 5 minutes

  3. Satisfaction evaluation

    Time frame: Less than 5 minutes

    Satisfaction of phlebotomists and parents will be assessed by a Likert-type survey administered immediately after the blood draw

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Efficacy of Distraction on Reduction of Procedural Pain Associated With Venipuncture in the Pediatric Post-Transplant Population

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2016
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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