Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children

Abstract

IntroductionIntravenous insertion (IVI) is a very common procedure in the emergency department (ED). IVI is often painful and stressful for both children and their families. Currently, distraction therapy is not used as a standard of care for IVI in North America. We propose that interaction with a humanoid robot may effectively distract children during IVI thereby reducing their pain and distress.Methods and analysisThis randomised controlled superiority trial will be conducted in a Canadian paediatric ED. We plan to recruit 80 patients. Children will be eligible if they (1) are 6 to 11 years of age, (2) need an IVI, (3) are fully conscious and alert, (4) have sufficient knowledge of the English language to understand and complete the study assessments and (5) are accompanied by a legal guardian. Our primary objective is to compare patient-reported pain and distress with the use of distraction (via a humanoid robot) versus standard care in children. The primary outcomes will be (1) self-reported pain, as measured by the Faces Pain Scale—Revised and (2) observed distress, as measured by the Observational Scale of Behavioural Distress—Revised. Secondary outcomes will include (1) measuring parental anxiety, (2) examining the association between parental anxiety and child outcomes and (3) children’s degree of engagement with the humanoid robot via the Intrinsic Motivation Inventory tool. First enrolment occurred in April 2017 and is ongoing.Ethics and disseminationThis study has been approved by the Health Research Ethics Board (University of Alberta). Informed consent to participate will be obtained from all participants’ parents/guardian, in conjunction with assent from the participant themselves. This study data will be submitted for publication regardless of results. Purchase of the robot was facilitated through a Stollery Children’s Hospital Foundation donation. Recruitment costs are supported by the Women and Children’s Health Research Institute.Trial registration number NCT02997631; Pre-results.

RETRACTED ARTICLE: Effects of artificial intelligence aibo intervention on alleviating distress and fear in children

“…The results showed that compared to the control group, the children in the intervention group did not stop crying but smiled more during vaccination. Other studies have reported that humanoid robots intervening during the procedure can distract children [ 3 ], help reduce anxiety, cope with stress, and improve behavior during the procedure [ 4 ]. Such AI-based distraction, as a non-pharmacological method, can be widely applied in the field of pediatric medicine.…”

Socially Assistive Robots as Mental Health Interventions for Children: A Scoping Review

“…It is equipped with a camera, two microphones, beat detection, touch sensors, foot sensors, orientation sensor, infrared mouth sensor. Three articles out of the sixteen included in the review mentioned what types of sanitation the robot require between interactions with children, two reporting on Nao being wiped down [43,44] and one reporting on Huggable's fur being removed, wiped down and washed between interactions [39]. Sanitation methods are important, as the ability to sanitize the robot may determine its appropriateness to use in a hospital setting.…”

“…Four studies reported on using robots as distractions for children during a medical procedure. Ali et al [44] in their RCT protocol described a plan to use pre-programmed Nao robot to distract children during venipuncture procedure at a hospital. The robot will engage the child in conversation and activity and will invite the child to blow during intravenous needle insertion (IVI) to minimize the pain.…”

“…Other limitations appearing in the papers include: recruitment difficulties [53,54], self-selection of participants [53,54], limited followup with the participants/their parents [43], raters of behaviour not being blinded to the intervention type [43], the brevity of interaction with the robot, technical difficulties interrupting the flow of the interaction [19,47], single site of intervention [19] and lack of objective measurements [48] or controls [48]. Three studies did not report any limitations [39,40,50,51] and one paper described a study protocol [44].…”

A non-randomized controlled trial for the effectiveness of the ‘aibo’ intervention program for distraction in childhood vaccination

“…Other studies have reported that humanoid robots intervening during the procedure can distract children [3], help reduce anxiety, cope with stress, and improve behavior during the procedure [4]. Such AI-based distraction, as a non-pharmacological method, can be widely applied in the eld of pediatric medicine.…”