Pain, ProceduralNCT03004456
Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
A study testing Distraction in people with Pain, Procedural and Distress, Procedural, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pain, Procedural, Distress, Procedural, Venipuncture
- What is being tested?
- Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 13 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- History of solid organ transplantation
- Undergoing venipuncture
Who cannot join
- Blood being drawn from a central line
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Efficacy of Distraction on Reduction of Procedural 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.
Read the 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.
- Conditions
- Pain, Procedural, Distress, Procedural, Venipuncture
- Being tested
- Distraction
- Keywords
- Phlebotomy, Pain, Distress
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DistractionOther
Also called iPad
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.
| Study group | Role | What they receive |
|---|---|---|
| Distraction | Experimental | 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. Receives: Other: Distraction |
| Standard of care | No intervention | Patients randomized to the "Standard of Care" group will not be provided with an iPad. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 1 minute
Secondary outcomes (3)
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.
Measured: 1 minute
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.
Measured: 1 minute
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).
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start10 May 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S Tsze, MD, MPH, Columbia University
- Investigators
- Daniel S Tsze, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004456
- Sponsor's protocol ID
- AAAQ8828
- Status last verified
- May 2025
- First submitted
- 23 Dec 2016
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Distraction on Reduction of Procedural Pain Associated With Venipuncture in the Pediatric Post-Transplant Population
- ClinicalTrials.gov ID
- NCT03004456
- Acronym / sponsor ID
- AAAQ8828
- Conditions
- Pain, Procedural, Distress, Procedural, Venipuncture
- Keywords
- Phlebotomy, Pain, Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distraction | Experimental | Other: DistractionPatients 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 intervention | –Patients randomized to the "Standard of Care" group will not be provided with an iPad. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- History of solid organ transplantation
- Undergoing venipuncture
Key exclusion criteria (1 listed)
- Blood being drawn from a central line
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DistractionAlso: iPadDistraction 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 | Distraction |
Primary outcome
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."
3 secondary outcomes
Observational Scale of Behavioral Distress - revised (OSBD-r)
Time frame: 1 minute
Faces-Leg- Activity-Cry-Consolability (FLACC)
Time frame: 1 minute
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Tsze, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction in people with Pain, Procedural and Distress, Procedural, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faces Pain Scale - Revised (FPS-R) (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.