Distraction and Vibration for Minimizing Pain During Childhood Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Duration of crying in seconds
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Refuses to sign the consent form.
- •Have already been included in the study previously.
研究组 & 干预措施
Video 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.
干预措施: Distraction (Behavioral)
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.
干预措施: Buzzy specific vibration device (Device)
Distraction plus vibration
Combination of the two interventions described above
干预措施: Buzzy specific vibration device (Device)
Distraction plus vibration
Combination of the two interventions described above
干预措施: Distraction (Behavioral)
Usual care
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.
结局指标
主要结局
Duration of crying in seconds
时间窗: Through study completion, an average 6 months
The duration of crying will be used as surrogate endpoint to assess pain
次要结局
- The satisfaction of parents(Through study completion, an average 6 months)
研究者
Marcio Manozzo Boniatti
Professor
Hospital Nossa Senhora da Conceicao