Using a Humanoid Robot to Distract Children With Chronic Conditions Undergoing Painful Procedures: a Pilot Randomized Controlled Trial Looking at Alterations of Children's and Parents' Pain and Fear Memories
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Pain memory bias (faces pain scale - revised) (child)
研究概览
简要总结
The aim of this study is to examine the effect of using a humanoid robot during a painful puncture procedure (e.g., portal catheter punction, IV punctures, blood withdrawal, etc.) in children with chronic conditions (e.g., chronic immune deficiency, colitis ulcerosa, metabolic disorders, cystic fibrosis, etc.) on the pain and fear memory of child and parent in comparison to usual care. The use of a humanoid robot has proven to be effective on reducing healthy children's pain and distress towards vaccinations. Still, whether these benefits generalize to chronically ill children, to pain/fear memories and to the parents needs to be examined.
The current research proposal is the first one to examine the use of a humanoid robot to distract children with chronic conditions who undergo repeated painful procedures and, compared to usual care, its effectiveness in reducing negative pain and fear experience and reducing negative pain and fear memory biases.
Children aged 8-12y with chronic conditions receiving regular treatment by painful puncture procedures, and their parents will be recruited at the University Hospital Brussels and Ghent. Baseline assessments include child's anticipated pain, pain-related fear and self-efficacy by child's self-report and parent proxy report, child's attention control, attention bias, pressure hyperalgesia, energy-balance related behavior, child's and parent's catastrophizing about the child's pain, parental behavioral responses to their child's pain and parent's emotions towards the child's painful procedure. Stratified block randomization will be used to assign the children to the control group (usual care) or intervention group (robot distraction). Immediately after the puncture procedure, experienced pain, pain-related fear, self-efficacy and pain catastrophizing (state) will be assessed again by child and parent, as well as emotions of the parent. One week post-procedure the participants will be contacted by telephone for a short interview in order to assess child's and parent's pain and pain-related fear memory, as well as child's and parent's future pain, pain-related fear and self-efficacy expectancies using the same scales as administered before and immediately after the procedure, with in addition a free recall and prompted recall about contextual details about the day of the procedure. Recalled pain and pain-related fear ratings that are higher compared to initial reports are considered indicative of negative memory biases.
详细描述
Objectives
The main objective of this pilot RCT is to examine if distraction by using a humanoid robot during a painful puncture procedure (I) contributes to less negative pain and pain-related fear memory biases (O) in comparison with the usual care (C) in children with chronic conditions between 8 and 12 years old and their parents (P). Furthermore, it wil be investigated if the use of a humanoid robot to distract these children during a puncture procedure contributes to lower levels of self-reported experienced pain-related fear and pain during the puncture and less negative expectations regarding future painful procedures. The investigators expect to see the same positive effects in the proxy reports of the parents. Also, the role of possible moderator variables such as child's self-efficacy, attention control, attention bias and energy-balance related behavior, child's and parent's pain catastrophizing about the child's pain, parent's emotions and responses to children's pain episodes will be investigated.
Methods
Participant recruitment
Patients will be recruited by the children's hospital of the University Hospital Brussels and Ghent. All children between 8-12y with chronic (non-primary pain) condition undergoing regular painful puncture procedures as part of their treatment, and their parents will be informed about the study and receive a consent form. The recruitment procedure will start in July 2019 and pursue until the calculated sample size is reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants:
- •Chronic disease
- •Willing to participate and comply with pre-determined interventions
- •8-12y (children)
- •Child and parent(s)/guardian cohabited for the past 5 years or, in case of divided custody, for at least half of the child's lifetime
- •Currently being treated (not necessarily hospitalized) in the University Hospital Brussels
排除标准
- •Developmental disabilities (e.g.: autism spectrum disorder, Attention Deficit (Hyperactivity) Disorder)
- •Psychiatric disorders (e.g.: anxiety disorder, personality disorder)
- •Significant vision or hearing impairment
- •Not able to read and speak fluent Dutch (parent and child)
研究组 & 干预措施
Usual care group (control group)
Within the usual care, no one of the attendees in the room will have specific interaction with the child during this procedure, with the exception of normal/necessary interaction by the nurse and/or parent. Only minimal distraction is allowed. The child will sit down on the treatment table with the legs stretched out in front of him and the puncture-side arm in a 90-90 position next to the head or stretched out and lying down along the body, with the nurse at the puncture side and the parent at the other side standing next to him. The researcher is also present in the room, within the child's field of vision. At the end of the procedure, the nurse tells the child that he/she did very well.
干预措施: Usual care (Behavioral)
Robot-assisted puncture procedure (experimental group)
During the experimental intervention, the child, a nurse, one of the parents/guardians, a researcher and the humanoid robot NAO (H25 Academic Edition, Aldebaran Robotics, Paris, France) will be present in the same room. The child will sit down in the same position as with the usual care. Next to the patient a humanoid robot of three-foot tall will sit on eye level on a slanted reading table, at the non-puncture side. The nurse will carry out the puncture procedure as performed as usual. The robot is programmed to distract the child during the entire procedure (before, during and after the puncture) by playing a game with the child based on his/her interests. The child can therefore choose between a number of games in different themes. In the end the robot tells the child that he/she did very well. During the whole intervention, the robot will be re-activated for each phase only when the child and the nurse are ready.
干预措施: Robot-assisted puncture procedure (Behavioral)
结局指标
主要结局
Pain memory bias (faces pain scale - revised) (child)
时间窗: 1 week post-intervention (calculation method = T3-T1 and T3-T2)
Pain rated by self-report using the Faces Pain Scale Revised (FPS-R) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).
Pain-related fear memory bias (numeric rating scale) (child)
时间窗: 1 week post-intervention (calculation method = T3-T1 and T3-T2)
Pain-related fear rated by self-report on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).
Pain-related fear memory bias (children's fear scale) (child)
时间窗: 1 week post-intervention (calculation method = T3-T1 and T3-T2)
Pain-related fear rated by self-report using the Children's Fear Scale (CFS) reported 1 week post-intervention (T3) minus anticipated pain-related fear reported just before intervention (T1), and pain-related fear reported 1 week post-intervention (T3) minus experienced pain-related fear reported immediately after intervention (T2).
Pain memory bias (numeric rating scale) (child)
时间窗: 1 week post-intervention (calculation method = T3-T1 and T3-T2)
Pain rated by self-report on an 11-point numeric rating scale (NRS-11) reported 1 week post-intervention (T3) minus anticipated pain reported just before intervention (T1), and pain reported 1 week post-intervention (T3) minus experienced pain reported immediately after intervention (T2).
次要结局
- pain intensity (numeric rating scale) (proxy report parent)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- pain intensity (faces pain scale - revised) (self-report child)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- pain-related fear (numeric rating scale) (self-report child)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- pain-related fear (numeric rating scale) (proxy report parent)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- pain intensity (numeric rating scale) (self-report child)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- pain intensity (faces pain scale - revised) (proxy report parent)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- pain-related fear (children's fear scale) (proxy report parent)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- self-efficacy (numeric rating scale) (self-report child)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- pain-related fear (children's fear scale) (self-report child)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- self-efficacy (numeric rating scale) (proxy report parent)(Just before intervention (T1), immediately after intervention (T2) and recall 1 week post-intervention (T3))
- Pain memory bias (numeric rating scale) (parent)(1 week post-intervention (calculation method = T3-T1 and T3-T2))
- Pain-related fear memory bias (children's fear scale) (parent)(1 week post-intervention (calculation method = T3-T1 and T3-T2))
- Fat mass (child)(Just before intervention (T0))
- Muscle mass (child)(Just before intervention (T0))
- Pain memory bias (faces pain scale - revised) (parent)(1 week post-intervention (calculation method = T3-T1 and T3-T2))
- Pain-related fear memory bias (numeric rating scale) (parent)(1 week post-intervention (calculation method = T3-T1 and T3-T2))
- Responses to the children's pain experience (parent)(Day before the intervention (T0))
- Emotions to children's pain experience (parent)(Just before intervention (T1) and immediately after intervention (T2))
- Fat free mass (child)(Just before intervention (T0))
- Total body water (child)(Just before intervention (T0))
- Extracellular water (child)(Just before intervention (T0))
- Body mass index (child)(Just before intervention (T0))
- Visceral fat rating (child)(Just before intervention (T0))
- Duration of procedure(During intervention)
- Waist circumference (child)(Just before intervention (T0))
- Body fat percentage (child)(Just before intervention (T0))
- Intracellular water (child)(Just before intervention (T0))
- Desire for robot-interaction for future procedures(Immediately after the intervention (T2))
- Body length (child)(Just before intervention (T0))
- Body weight (child)(Just before intervention (T0))
- Attention control (child)(Day before the intervention (T0))
- Attention bias (child)(Just before intervention (T0))
- Pressure hyperalgesia (child)(Just before intervention (T0))
- Total body water percentage (child)(Just before intervention (T0))
- Basal metabolic rate (child)(Just before intervention (T0))
- Satisfaction with the robot-interaction(Immediately after the intervention (T2))
研究者
Emma Rheel
PhD student
Vrije Universiteit Brussel