Distraction and Vibration for Minimizing Pain During Childhood Vaccination
- Conditions
- Pain Due to Childhood Vaccination
- Interventions
- Device: Buzzy specific vibration deviceBehavioral: Distraction
- Registration Number
- NCT03540589
- Lead Sponsor
- Hospital Nossa Senhora da Conceicao
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
- 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.
- Refuses to sign the consent form.
- Have already been included in the study previously.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vibration device Buzzy specific vibration device Buzzy® 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 Buzzy specific vibration device Combination of the two interventions described above Distraction plus vibration Distraction Combination of the two interventions described above Video distraction Distraction 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.
- Primary Outcome Measures
Name Time Method Duration of crying in seconds Through study completion, an average 6 months The duration of crying will be used as surrogate endpoint to assess pain
- Secondary Outcome Measures
Name Time Method The satisfaction of parents Through study completion, an average 6 months The satisfaction of parents will be evaluated through a questionnaire
Trial Locations
- Locations (1)
Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil