School of Nursing, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.
Evidence-to-Practice Program, Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.
Pediatr Blood Cancer. 2018 Sep;65(9):e27242. doi: 10.1002/pbc.27242. Epub 2018 Jun 12.
Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses.
This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims.
Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm.
The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739.
癌症患儿皮下端口针插入操作会引起疼痛和不适。互动式 MEDiPORT 机器人经过编程，可以实施心理策略，以减轻该过程中的疼痛和不适。本研究评估了未来 MEDiPORT 试验的可行性。次要目标是确定 MEDiPORT 在减轻儿童皮下端口进入时的疼痛和不适方面的初步效果。
这是一项为期 5 个月的试点随机对照试验，使用基于网络的服务将 4 至 9 岁的癌症患儿随机分配到 MEDiPORT 认知行为组（机器人使用基于证据的认知行为干预）或主动分散注意力组（机器人跳舞和唱歌），同时护士进行针插入操作。我们评估了入组和保留率；技术困难；儿童、家长和护士完成的结果测量；完成研究和临床程序的时间；以及儿童、家长和护士对可接受性的评价。采用描述性分析和对儿童疼痛和痛苦数据的探索性推断性检验来解决研究目的。
40 名儿童随机分配到研究组。大多数（85%）符合条件的儿童参与了研究，没有儿童退出。认知行为组的技术困难更为常见。研究和针插入的完成时间可接受，超过 96%的结果测量项目完成。总体而言，MEDiPORT 和研究对参与者是可接受的。两组之间的疼痛没有差异，但主动分散注意力组的过程中痛苦程度较轻。
对干预措施和研究方案进行修改后，MEDiPORT 研究似乎可以实施为一项具有足够效力评估的试验。ClinicalTrials.gov NCT02611739。
