Animal Assisted Activity, Clowns and Music for the Reduction of Distress and Pain in Children During Venipuncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Distress
研究概览
简要总结
To evaluate the efficacy of Health Support Activities (Animal Assisted Intervention, Clows, Musicians) in the reduction of pain and distress in children undergoing venipuncture.
Hypothesis: the investigators expect a reduction in in pain and distress.
详细描述
Venipuncture is one of the most unpleasant procedures for children. Previous studies demonstrated the effectiveness of distraction techniques in reducing anxiety and pain but no one compares the specific activities of animals assisted intervention (AAI), clowns and musicians for this procedure.
In the Hospital involved in the present study, venipuncture service has a week schedule for Health Support Activities. In specific days children can benefit of Health Support Activities as part of routine care.
Aims of the present study are: evaluate efficacy of AAI, clowns and musicians in the reduction of childrens' distress and pain during venipuncture with respect of a control group undergoing venipuncture in the days where Health Support Activities are not scheduled; compare distress and pain levels between groups; evaluate caregiver's anxiety and its influence on child pain and distress; explore parents' and staff opinion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatients
- •scheduled to venipuncture
- •Italian speaking
排除标准
- •cognitive and/or developmental impairment
结局指标
主要结局
Distress
时间窗: Distress assessment is one for every participant and begins when child enter in the venipuncture room and lasts until the child exit the venipuncture room, in the day of recruitment. .
Brief Behavioral Distress Scale - BBDS is an observational measure that assess children's procedure-related distress with 12 discrete component steps involved in venipuncture, in order to observe specific demands for compliance on the child during the procedure. Observers record the occurrence or nonoccurrence of the target behaviors during each step. Operational definitions of the target behaviors for each category are: 1) Non interfering Distress Behaviors; 2) Potentially Interfering Distress Behaviors; 3) Interfering Distress Behaviors. The number of steps in which a behavior occur is summed and divided by the total number of steps, then multiplied by 100 to yield percentage of steps with occurrence scores for each behavioral category. The number of steps in which behaviors from any of the three distress behavior categories occur is summed and divided by the total number of steps multiplied by three, then multiplied by 100 to obtain the Total Distress Score.
Pain perception 3-6 years old
时间窗: Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment
Numerical scales, based on age, Wong Baker Scale. The Wong Baker Faces Pain Rating Scale (Wong \& Baker, 1998) is a self-report scale for children older than 3 years old, that shows a sequence of faces ranging from a happy face at 0 level, that means "No hurt", to a crying face at 10th level, that means "Hurts worst".
Pain perception from 7 years old
时间窗: Pain assessment is one for every participant, measured immediately after the child exit the venipuncture room, in the day of recruitment
Numerical scale, Visual Analogue Scale - VAS. VAS is used from the age of 7 years old, is a self-report numerical scale ranging from 0, that means "No pain", to 10, that means "worst pain".
次要结局
- Parent's state and trait anxiety(Parent's anxiety assessment is one for every participant, measured in the waiting room before child enters in the venipuncture room, in the day of recruitment)
研究者
Laura Vagnoli
Principal Investigator
Meyer Children's Hospital IRCCS