Pain ReliefPhase 3NCT02614391
Tablet Distraction for Pain Control During Venipuncture
A Phase 3 study testing Active distraction using a tablet and Passive distraction in people with Pain Relief, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted. The base for pain management starts with behavioural and environmental support and distraction. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Pain Relief
- What is being tested?
- Active distraction using a tablet and Passive distraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Jun 2013
- Phase
- Phase 3
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 to 13 years
- Need for venipuncture
- Informed consent signed by parents or legal guardians
Who cannot join
- Children with epilepsy
- Use of topical, enteral or parenteral analgesics within 8 hours before the procedure
- Inability to perform venipuncture on hand or arm
- Children with cognitive impairment or unable to report their pain verbally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Evaluate Tablet Distraction for Pain Control in Children Underwent Venipuncture
Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted.
The base for pain management starts with behavioural and environmental support and distraction. Distraction is a cognitive strategy trying to divert the child's attention from a noxious stimulus. Active distraction involves the child in a different performance, e.g. playing, during pain procedures. Passive distraction redirects the child's attention to visual or auditory stimuli using toys, songs, movies or blowing bubbles.
Read more
Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a limited time. Patients usually arrive without a pharmacological premedication and go away immediately after procedure. In this context distraction is an excellent pain relief tool.
The aim of the study is to compare the effectiveness of an active distraction (playing a videogame using a computer tablet) with a passive distraction technique in pain relief during venipuncture in a blood-drawing centre.
- Conditions
- Pain Relief
- Being tested
- Active distraction using a tablet, Passive distraction
- Keywords
- Procedural pain, Phlebotomy, Distraction, Videogame, Computer tablet, Child
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active distraction using a tabletOther
Playing a videogame using a computer tablet
Passive distractionOther
A nurses singing a song, reading a book, blowing bubbles and playing a puppet show
| Study group | Role | What they receive |
|---|---|---|
| Active distraction using a tablet | Experimental | Children were admitted in a comfortable room with a parent and started to play with a videogame suitable for their age three minutes before procedure. They continued to play the videogame during venipuncture. The use of a computer tablet permitted to play with one hand only. Receives: Other: Active distraction using a tablet |
| Passive distracion | Active comparator | Children were admitted in a comfortable room with a parent and received various kinds of passive distractions: nurses singing a song, reading a book, blowing bubbles and playing a puppet show. The technique that most engaged the child, was continued during procedure. Receives: Other: Passive distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score recorded by the Faces Pain Scale-Revised (FPS-R)
The pain during the procedure will be evaluated using the self-reported FPS-R scale
Measured: Intraprocedural (an average of 5 minutes)
Secondary outcomes (2)
Success at first attempt
Percentage of success at first attempt
Measured: Intraprocedural (an average of 5 minutes)
Adverse events
The number and the type of adverse events will be recorded
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 posted25 Nov 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
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 3
- 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, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Franca Crevatin, RN, Study chair, IRCCS Burlo GarofoloFranca Crevatin, RN, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614391
- Sponsor's protocol ID
- RC 38/12
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Tablet Distraction for Pain Control in Children Underwent Venipuncture
- ClinicalTrials.gov ID
- NCT02614391
- Acronym / sponsor ID
- RC 38/12
- Conditions
- Pain Relief
- Keywords
- Procedural pain, Phlebotomy, Distraction, Videogame, Computer tablet, Child
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Nov 2015 (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 painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted.
The base for pain management starts with behavioural and environmental support and distraction. Distraction is a cognitive strategy trying to divert the child's attention from a noxious stimulus. Active distraction involves the child in a different performance, e.g. playing, during pain procedures. Passive distraction redirects the child's attention to visual or auditory stimuli using toys, songs, movies or blowing bubbles.
Blood-drawing centre is a peculiar setting in which many procedures have to be performed in a limited time. Patients usually arrive without a pharmacological premedication and go away immediately after procedure. In this context distraction is an excellent pain relief tool.
The aim of the study is to compare the effectiveness of an active distraction (playing a videogame using a computer tablet) with a passive distraction technique in pain relief during venipuncture in a blood-drawing centre.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active distraction using a tablet | Experimental | Other: Active distraction using a tabletChildren were admitted in a comfortable room with a parent and started to play with a videogame suitable for their age three minutes before procedure. They continued to play the videogame during venipuncture. The use of a computer tablet permitted to play with one hand only. |
| Passive distracion | Active comparator | Other: Passive distractionChildren were admitted in a comfortable room with a parent and received various kinds of passive distractions: nurses singing a song, reading a book, blowing bubbles and playing a puppet show. The technique that most engaged the child, was continued during procedure. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 4 to 13 years
- Need for venipuncture
- Informed consent signed by parents or legal guardians
Key exclusion criteria (4 listed)
- Children with epilepsy
- Use of topical, enteral or parenteral analgesics within 8 hours before the procedure
- Inability to perform venipuncture on hand or arm
- Children with cognitive impairment or unable to report their pain verbally
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 |
|---|---|---|
| Active distraction using a tabletPlaying a videogame using a computer tablet | Other | Active distraction using a tablet |
| Passive distractionA nurses singing a song, reading a book, blowing bubbles and playing a puppet show | Other | Passive distracion |
Primary outcome
Pain score recorded by the Faces Pain Scale-Revised (FPS-R)
Time frame: Intraprocedural (an average of 5 minutes)
The pain during the procedure will be evaluated using the self-reported FPS-R scale
2 secondary outcomes
Success at first attempt
Time frame: Intraprocedural (an average of 5 minutes)
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 30 Nov 2015.
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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.
Franca Crevatin, RN study chair
IRCCS Burlo Garofolo
Franca Crevatin, RN principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active distraction using a tablet and Passive distraction in people with Pain Relief, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 3 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 30 Nov 2015. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain score recorded by the Faces Pain Scale-Revised (FPS-R) (time frame: Intraprocedural (an average of 5 minutes)). 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 30 Nov 2015; AzTrials last refreshed its copy on 29 Oct 2026.