Pain ReliefNCT02969902
Buzzy Distraction During Venipuncture
A study testing Buzzy® device and Hand-held computer in people with Pain Relief, run by IRCCS Burlo Garofolo.
Trial summary
Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pain Relief
- What is being tested?
- Buzzy® device and Hand-held computer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Feb 2015
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children from 4 to 12 years of age needing venipuncture
Who cannot join
- the presence of damage, denuded or broken skin in the site of Buzzy application;
- use of topical, enteral or parenteral analgesics within eight hours before enrolment;
- the presence of cognitive impairment or the inability to report pain verbally;
- the presence of chronic disease, included epilepsy, or of diseases associated with cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease).
About this study
Official title: Randomized Controlled Trial to Compare Buzzy and Hand-held Computer Distraction for Pain Control in Children Underwent Venipuncture.
Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Pain and anxiety management is even more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture related pain and distress, with a strong evidence supporting its efficacy in children and adolescents.
In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines distraction and physical analgesia (vibration and cold) and it was positively tested during venipuncture, intravenous cannulation and painful injections in children. Even though its efficacy it's well established, most of the published trials did not compare Buzzy with other interventions, so that little data are available about its usefulness compared with other distractions techniques.
Read more
Hand-held computers are reusable tools, which offer a technological-based active distraction. There is evidence supporting their used during painful procedures such as venipuncture and a recent published study showed that hand-held computer distraction was as effective as nurse-led passive distraction techniques in children.
The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in pain relief during venipuncture.
- Conditions
- Pain Relief
- Being tested
- Buzzy® device, Hand-held computer
- Keywords
- Procedural pain, Phlebotomy, Distraction, Hand-held computer, Children
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy® deviceDevice
Hand-held computerDevice
| Study group | Role | What they receive |
|---|---|---|
| Buzzy® device | Experimental | The Buzzy® device is applied just above the selected site of the venipuncture; an ice pack is attached under the device; the device is turned on and after 15 second the venipuncture is made. Receives: Device: Buzzy® device |
| Hand-held computer | Active comparator | Using an hand-held computer, children start to play with an age-appropriate videogame three minutes before the procedure. They continue to play during the venipuncture. Receives: Device: Hand-held computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain
Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10.
Measured: Within 5 minutes after the procedure
Secondary outcomes (4)
Pain evaluated by parents
Pain evaluated using a Numerical Rating Scale, with scores from zero to 10
Measured: Within 5 minutes after the procedure
Pain evaluated by nurses
Pain evaluated using a Numerical Rating Scale, with scores from zero to 10
Measured: Within 5 minutes after the procedure
Success at first attempt
Percentage of success at first attempt
Measured: Intraprocedural
Adverse events
The number and the type of adverse events
Measured: Up to 15 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ReliefStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ronfani, IRCCS Burlo Garofolo
- Investigators
- Egidio Barbi, MD, Study chair, IRCCS Burlo GarofoloFranca Crevatin, RN, Study director, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969902
- Sponsor's protocol ID
- RC 19/13
- Status last verified
- Aug 2017
- First submitted
- 17 Nov 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Compare Buzzy and Hand-held Computer Distraction for Pain Control in Children Underwent Venipuncture.
- ClinicalTrials.gov ID
- NCT02969902
- Acronym / sponsor ID
- RC 19/13
- Conditions
- Pain Relief
- Keywords
- Procedural pain, Phlebotomy, Distraction, Hand-held computer, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Nov 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.
Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Pain and anxiety management is even more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture related pain and distress, with a strong evidence supporting its efficacy in children and adolescents.
In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines distraction and physical analgesia (vibration and cold) and it was positively tested during venipuncture, intravenous cannulation and painful injections in children. Even though its efficacy it's well established, most of the published trials did not compare Buzzy with other interventions, so that little data are available about its usefulness compared with other distractions techniques.
Hand-held computers are reusable tools, which offer a technological-based active distraction. There is evidence supporting their used during painful procedures such as venipuncture and a recent published study showed that hand-held computer distraction was as effective as nurse-led passive distraction techniques in children.
The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in pain relief during venipuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy® device | Experimental | Device: Buzzy® deviceThe Buzzy® device is applied just above the selected site of the venipuncture; an ice pack is attached under the device; the device is turned on and after 15 second the venipuncture is made. |
| Hand-held computer | Active comparator | Device: Hand-held computerUsing an hand-held computer, children start to play with an age-appropriate videogame three minutes before the procedure. They continue to play during the venipuncture. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children from 4 to 12 years of age needing venipuncture
Key exclusion criteria (4 listed)
- the presence of damage, denuded or broken skin in the site of Buzzy application;
- use of topical, enteral or parenteral analgesics within eight hours before enrolment;
- the presence of cognitive impairment or the inability to report pain verbally;
- the presence of chronic disease, included epilepsy, or of diseases associated with cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease).
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 |
|---|---|---|
| Buzzy® device | Device | Buzzy® device |
| Hand-held computer | Device | Hand-held computer |
Primary outcome
Self-reported pain
Time frame: Within 5 minutes after the procedure
Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10.
4 secondary outcomes
Pain evaluated by parents
Time frame: Within 5 minutes after the procedure
Pain evaluated by nurses
Time frame: Within 5 minutes after the procedure
Success at first attempt
Time frame: Intraprocedural
Adverse events
Time frame: Up to 15 minutes after the procedure
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 21 Aug 2017.
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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.
Egidio Barbi, MD study chair
IRCCS Burlo Garofolo
Franca Crevatin, RN study director
IRCCS Burlo Garofolo
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy® device and Hand-held computer in people with Pain Relief, run by IRCCS Burlo Garofolo.
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 1 inclusion and 4 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Self-reported pain (time frame: Within 5 minutes after the procedure). 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 21 Aug 2017.