Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children, a Multicenter Randomized Prospective Study.
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
- 6
- 主要终点
- Pain assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) scale.
研究概览
简要总结
Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are closely interrelated. Effective management of pain and anxiety is therefore essential to optimize the child's well-being in the short, medium, and long term.
The quality of pediatric analgesia relies on a multimodal approach combining pharmacological and non-pharmacological interventions. In recent years, several non-pharmacological strategies have been developed to reduce pain and anxiety. Among these, innovative technologies such as therapeutic assistance robots incorporating artificial intelligence have emerged; however, their clinical benefits remain to be established.
The present study aims to evaluate the effectiveness of PARO, a therapeutic assistance robot designed in the form of a baby seal, in the management of pain during peripheral intravenous catheterization in children. The investigators will compare the effects of PARO in combination with standard care versus standard care alone during needle-related procedures. The primary objective is to determine whether the use of this device improves pain management in children undergoing skin puncture.
This study is designed as a multicenter, randomized, open-label, superiority trial conducted across five pediatric centers. A total of 120 infants and children aged 12 months to 7 years undergoing peripheral intravenous catheterization will be enrolled. Pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale, which is validated for this age group.
Secondary objectives include the assessment and comparison of procedural distress between groups using the PRIC (Procedural Restraint Intensity in Children) score, evaluation of heart rate variability, number of catheterization attempts, parental anxiety measured by the STAI (State-Trait Anxiety Inventory), and satisfaction levels among both parents and healthcare staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 months and 7 years.
- •Requirement for peripheral intravenous catheterization (PIC).
- •Written informed consent obtained from at least one parent or legal guardian.
- •Affiliation with the national health insurance system (social security).
排除标准
- •Requirement for contact isolation, including colonization or infection with multidrug-resistant organisms (MDROs).
- •Visual or hearing impairment.
- •Known psychiatric disorder.
- •Inability to understand French.
- •Life-threatening emergency requiring immediate intervention.
- •Need for strong analgesic medication (e.g., morphine, ketamine, or intranasal analgesics).
研究组 & 干预措施
Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti
The child will be admitted to the emergency department.
If topical anesthesia (EMLA cream) is used to reduce pain, it will be applied to the skin 30 to 60 minutes prior to the procedure.
To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure.
If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child.
The procedure will begin with skin disinfection and identification of a suitable vein.
For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin.
The procedure will be considered complete once the needle is withdrawn and a dressing is applied.
干预措施: Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot. (Device)
Control group : standard multimodal stratgey
The child will be admitted to the emergency department.
If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin prior to the procedure.
If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, the child will inhale the gas via a mask during the procedure.
Non-pharmacological interventions, such as music therapy and/or watching cartoons, may also be used as part of standard care.
The procedure will begin with skin disinfection and identification of a suitable vein.
For the purposes of the study, the start of the procedure is defined as the moment the needle first penetrates the skin.
The procedure is considered complete once the needle is withdrawn and a dressing is applied.
干预措施: Non-pharmacological and standard pharmacological interventions. (Other)
结局指标
主要结局
Pain assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) scale.
时间窗: periprocedural
The effectiveness of PARO in reducing pain during the procedure will be assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) hetero-evaluation scale. The FLACC is a validated hetero-assessment tool used for the evaluation of pain in children aged between 12 months and 7 years old, particulary in the immediate postoperative pain and during brief pain associated with medical procedures. This scale assesses five behavioral parameters: facial expression, leg movement, activity, crying, and consolability. Each parameter is scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates a relaxed and comfortable child, while scores between 7 and 10 reflect severe pain or significant distress. A score of 3 or above is considered to be the threshold for initiating pain treatment.
次要结局
- Heart rate measure(periprocedural)
- Parental anxiety assessment using the STAI (State Trait Anxiety Inventory) questionnaire.(at the end of the procedure)
- failure rate of peripheral intravenous catheterization(periprocedural)
- questionnaire of Parental satisfaction(15 minutes after the end of the procedure)
- Questionnaire of paramedical team satisfaction(15 minutes after the end of the procedure.)
- Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization(periprocedural)