Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction: Extra-can Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Observation Scale of Behavioral Distress (OSBD) registered at baseline, during and immediately after the intervention
研究概览
简要总结
The purpose of the present study is to evaluate the efficacy of Animal Assisted Therapy (AAT) during blood extraction or dental procedures in a Primary Care Pediatric Service. Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals. Estimate the reduction in the child's emotional stress during these procedures with the support of a therapy dog. Evaluate the emotional stress in the accompanying family member. These objectives will be accomplished through a randomized open label two-arm controlled study of AAT for children who need a blood or dental extraction.
详细描述
INTRODUCTION
Venous puncture for routine blood sampling can be distressing for many children, leading to heightened anxiety both before and during the procedure. Dental anxiety affects around 9% of European children and adolescents, potentially persisting into adulthood and resulting in dental avoidance behaviors. Animal-assisted therapy (AAT) is viewed as a distraction technique that could play a vital role in managing pain and distress for children. AAT is a planned, structured therapeutic intervention with specific goals, facilitated by healthcare professionals.
OBJECTIVES: Evaluate the efficacy of AAT during blood or dental extraction in a Primary Care Pediatric Service. Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals. Estimate the reduction in the child's emotional stress during these procedures with the support of a therapy dog. Evaluate the emotional stress in the accompanying family member.
METHODOLOGY: Randomized two-arm clinical trial (control group and intervention group) involving children aged 3 to 8 requiring blood analysis or dental extraction in a Primary Health Care Center. Patients will be randomly assigned to the control and intervention groups. Sample size calculations suggest 60 patients in each group to detect statistically significant differences. The control group follows standard protocols, while the intervention group includes AAT with 10 minutes of pre-procedure interaction with the therapy dog, extraction performed with the therapy dog, and 5 minutes of post-procedure interaction. Personnel includes nurses or dentists, a pediatrician, and an AAT technician. Response variables include various scales measuring anxiety and distress, while control variables encompass age, gender, pathologies, extraction type, and pet ownership.
EXPECTED RESULTS: The implementation of AAT as an emotional support intervention, utilizing a therapy dog for distraction, is anticipated to improve symptomatology in the intervention group by reducing fear and anxiety post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Age between 3 and 12 years old.
- •Need a blood or dental extraction.
- •Willing to participate in the study on a voluntary basis.
- •Delivery of the information sheet and signature the informed consent.
排除标准
- •If in the initial interview they declared having allergy or fear of dogs.
- •Have aggression disorder towards dogs.
- •Not want to participate in the study.
结局指标
主要结局
Observation Scale of Behavioral Distress (OSBD) registered at baseline, during and immediately after the intervention
时间窗: This scale registered behaviors in continuous 15-second intervals at baseline, during and immediately after the intervention
Is an instrument for measuring children's distress during painful medical procedures, assessed by an external observer. It is a 4-point Likert-type scale instrument (where the numerical values are weighted from 0 (not at all) to 3 (very much)) that evaluates 11 different behaviors
次要结局
- State-Trait Anxiety Inventory Questionnaire (STAI) registered at baseline and immediately after the intervention(This questionnaire will be administered at baseline and immediately after the intervention, post-extraction.)
- Wong-Baker Faces Scale registered at baseline and immediately after the intervention(This scale will be administered at baseline and immediately after the intervention, post-extraction.)
研究者
Esther Rodrigo Claverol
Graduate in Medicine
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina