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

Primary Purpose

Pain, Procedural, Distress, Procedural, Venipuncture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Distraction
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Procedural focused on measuring Phlebotomy, Pain, Distress

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of solid organ transplantation
  • Undergoing venipuncture

Exclusion Criteria:

  • Blood being drawn from a central line

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Distraction

Standard of care

Arm Description

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.

Patients randomized to the "Standard of Care" group will not be provided with an iPad.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Observational Scale of Behavioral Distress - revised (OSBD-r)
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)
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)
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).

Full Information

First Posted
December 23, 2016
Last Updated
April 17, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03004456
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural, Distress, Procedural, Venipuncture
Keywords
Phlebotomy, Pain, Distress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distraction
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Patients randomized to the "Standard of Care" group will not be provided with an iPad.
Intervention Type
Other
Intervention Name(s)
Distraction
Other Intervention Name(s)
iPad
Intervention Description
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.
Primary Outcome Measure Information:
Title
Faces Pain Scale - Revised (FPS-R)
Description
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."
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Observational Scale of Behavioral Distress - revised (OSBD-r)
Description
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.
Time Frame
1 minute
Title
Faces-Leg- Activity-Cry-Consolability (FLACC)
Description
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.
Time Frame
1 minute
Title
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
Description
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).
Time Frame
1 minute
Other Pre-specified Outcome Measures:
Title
Time to successful venipuncture
Description
Defined as the time from placing of tourniquet to completion of collection of the first tube.
Time Frame
Less than 5 minutes
Title
Number of attempts necessary for successful blood draw.
Time Frame
Less than 5 minutes
Title
Satisfaction evaluation
Description
Satisfaction of phlebotomists and parents will be assessed by a Likert-type survey administered immediately after the blood draw
Time Frame
Less than 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of solid organ transplantation Undergoing venipuncture Exclusion Criteria: Blood being drawn from a central line
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Tsze, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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