Pain Due to Childhood VaccinationNCT03540589
Distraction and Vibration for Minimizing Pain During Childhood Vaccination
A study testing Buzzy specific vibration device and Distraction in people with Pain Due to Childhood Vaccination, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
Vaccine pain control is one of the actions suggested to support the delivery of vaccines that are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main reasons why children and their parents fail to do them properly. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Due to Childhood Vaccination
- What is being tested?
- Buzzy specific vibration device and Distraction
- Type of treatment
- Vaccines, Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteBrazil
- Study dates
- 21 May 2018to 30 Oct 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 1 year and 3 years, 11 months and 29 days of life.
- Be accompanied by legal guardian.
- Apply only one injectable vaccine at the time of the research.
Who cannot join
- Refuses to sign the consent form.
- Have already been included in the study previously.
Trial locations and contacts
1 site in 1 country.
About this study
Vaccine pain control is one of the actions suggested to support the delivery of vaccines that are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main reasons why children and their parents fail to do them properly. Thus, it is very important to investigate which interventions can bring greater benefit in the control of pain.This is a randomized clinical trial aiming to assess the impact of video distraction and vibration device on pain during the vaccination of children between one and three years.
- Conditions
- Pain Due to Childhood Vaccination
- Being tested
- Buzzy specific vibration device, Distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy specific vibration deviceDevice
It is a device that produces vibration
DistractionBehavioural
The distraction will be obtained through tablet with videos
| Study group | Role | What they receive |
|---|---|---|
| Video distraction | Experimental | A video will be available as soon as the child is randomized to this group, thus enabling the child to become more involved with distraction. A tablet will be delivered to the parents in the reception room to be viewed by the child before entering the vaccine room. After entering the room, the parents will keep the child entertained with the videos. There will be several videos, and it may be optional for the parents to choose according to their preferences. Receives: Behavioral: Distraction |
| Vibration device | Experimental | Buzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure. Receives: Device: Buzzy specific vibration device |
| Distraction plus vibration | Experimental | Combination of the two interventions described above Receives: Device: Buzzy specific vibration device; Behavioral: Distraction |
| Usual care | No intervention | The vaccine will be carried out according to the routine of the Vaccine Center. Lidocaine plus prilocaine, non-nutritive sucking or breastfeeding may be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of crying in seconds
The duration of crying will be used as surrogate endpoint to assess pain
Measured: Through study completion, an average 6 months
Secondary outcomes (1)
The satisfaction of parents
The satisfaction of parents will be evaluated through a questionnaire
Measured: Through study completion, an average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start21 May 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Due to Childhood VaccinationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcio Manozzo Boniatti, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540589
- Sponsor's protocol ID
- PCV-001
- Status last verified
- Feb 2019
- First submitted
- 23 Apr 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction and Vibration for Minimizing Pain During Childhood Vaccination
- ClinicalTrials.gov ID
- NCT03540589
- Acronym / sponsor ID
- PCV-001
- Conditions
- Pain Due to Childhood Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 30 May 2018 (actual)
- 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.
Vaccine pain control is one of the actions suggested to support the delivery of vaccines that are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main reasons why children and their parents fail to do them properly. Thus, it is very important to investigate which interventions can bring greater benefit in the control of pain.This is a randomized clinical trial aiming to assess the impact of video distraction and vibration device on pain during the vaccination of children between one and three years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Video distraction | Experimental | Behavioral: DistractionA video will be available as soon as the child is randomized to this group, thus enabling the child to become more involved with distraction. A tablet will be delivered to the parents in the reception room to be viewed by the child before entering the vaccine room. After entering the room, the parents will keep the child entertained with the videos. There will be several videos, and it may be optional for the parents to choose according to their preferences. |
| Vibration device | Experimental | Device: Buzzy specific vibration deviceBuzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure. |
| Distraction plus vibration | Experimental | Device: Buzzy specific vibration device, Behavioral: DistractionCombination of the two interventions described above |
| Usual care | No intervention | –The vaccine will be carried out according to the routine of the Vaccine Center. Lidocaine plus prilocaine, non-nutritive sucking or breastfeeding may be used. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 1 year and 3 years, 11 months and 29 days of life.
- Be accompanied by legal guardian.
- Apply only one injectable vaccine at the time of the research.
Key exclusion criteria (2 listed)
- Refuses to sign the consent form.
- Have already been included in the study previously.
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 specific vibration deviceIt is a device that produces vibration | Device | Distraction plus vibration, Vibration device |
| DistractionThe distraction will be obtained through tablet with videos | Behavioural | Distraction plus vibration, Video distraction |
Primary outcome
Duration of crying in seconds
Time frame: Through study completion, an average 6 months
The duration of crying will be used as surrogate endpoint to assess pain
1 secondary outcome
The satisfaction of parents
Time frame: Through study completion, an average 6 months
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 22 Feb 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy specific vibration device and Distraction in people with Pain Due to Childhood Vaccination, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
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 2 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 22 Feb 2019. 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 Brazil. 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?
Duration of crying in seconds (time frame: Through study completion, an average 6 months). 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 22 Feb 2019.