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

Pain, Procedural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004456
• Other study ID #: AAAQ8828
• Status: Completed
• Phase: N/A
• Start date: May 10, 2017
• Est. completion date: June 13, 2018

Study information

• Verified date: April 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• History of solid organ transplantation

• Undergoing venipuncture

Exclusion Criteria:

• Blood being drawn from a central line

Related Conditions & MeSH terms

• Distress, Procedural
• Pain, Procedural
• Venipuncture

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to successful venipuncture	Defined as the time from placing of tourniquet to completion of collection of the first tube.	Less than 5 minutes
Other	Number of attempts necessary for successful blood draw.		Less than 5 minutes
Other	Satisfaction evaluation	Satisfaction of phlebotomists and parents will be assessed by a Likert-type survey administered immediately after the blood draw	Less than 5 minutes
Primary	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	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.	1 minute
Secondary	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.	1 minute
Secondary	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).	1 minute