Buffel Connor, van Aalst June, Bangels Anne-Marie, Toelen Jaan, Allegaert Karel, Verschueren Sarah, Vander Stichele Geert
MindLab Interactive AI Inc, Edmonton, AB, Canada.
Division of Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium.
JMIR Serious Games. 2019 Jun 1;7(2):e12431. doi: 10.2196/12431.
As pediatric ambulatory surgeries are rising and existing methods to reduce perioperative anxiety and pain are lacking in this population, a serious game for health (SGH), CliniPup, was developed to address this unmet need. CliniPup was generated using the SERES framework for serious game development.
The goal of the research was to clinically evaluate CliniPup as an adjunct therapy to existing pharmacological interventions aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery.
CliniPup was evaluated in a prospective randomized controlled pilot trial in 20 children aged 6 to 10 years who underwent elective surgery and their parents. Study participants were randomly assigned to the test (n=12) or control group (n=8). Children in the test group played CliniPup 2 days prior to surgery, and children in the control group received standard of care. On the day of surgery, pediatric anxiety was measured with the modified Yale Preoperative Anxiety Scale and parental anxiety was assessed with the State-Trait Anxiety Inventory. Pediatric postoperative pain was assessed by the Wong-Baker Faces Pain Rating Scale. Child and parent user experience and satisfaction were also evaluated in the test group using structured questionnaires.
Despite the small sample, preoperative anxiety scores were significantly lower (P=.01) in children who played CliniPup prior to surgery compared to controls. Parental preoperative anxiety scores were also lower in the test group (P=.10) but did not reach significance. No significant differences were observed in postoperative pain scores between groups (P=.54). The evaluation of user experience and satisfaction revealed that both children and parents were satisfied with CliniPup and would recommend the game to peers.
Results of the pilot trial introduce CliniPup as a potentially effective and attractive adjunct therapy to reduce preoperative anxiety in children undergoing ambulatory surgery with a trend toward positive impact on parental preoperative anxiety. These results support the use of the SERES framework to generate an evidence-based SGH that results in positive health outcomes for patients. Based on these preliminary findings, we propose a research agenda to further develop and investigate this tool.
ClinicalTrials.gov NCT03874442; https://clinicaltrials.gov/ct2/show/NCT03874442 (Archived by WebCite at http://www.webcitation.org/78KZab8qc).
由于儿科门诊手术数量不断增加，而现有的减少围手术期焦虑和疼痛的方法在这一人群中尚不完善，因此开发了一款健康严肃游戏（SGH）——CliniPup，以满足这一未被满足的需求。CliniPup是使用用于严肃游戏开发的SERES框架生成的。
本研究的目的是对CliniPup进行临床评估，将其作为现有药物干预措施的辅助疗法，旨在减少接受门诊手术的儿童的围手术期焦虑和疼痛。
在一项前瞻性随机对照试验中，对20名年龄在6至10岁接受择期手术的儿童及其父母进行了CliniPup评估。研究参与者被随机分配到试验组（n=12）或对照组（n=8）。试验组的儿童在手术前两天玩CliniPup，对照组的儿童接受标准护理。在手术当天，用改良的耶鲁术前焦虑量表测量儿童焦虑，用状态-特质焦虑量表评估父母焦虑。用面部表情疼痛评分量表评估儿童术后疼痛。还使用结构化问卷对试验组的儿童和家长的用户体验及满意度进行了评估。
尽管样本量较小，但与对照组相比，术前玩CliniPup游戏的儿童术前焦虑评分显著更低（P=0.01）。试验组父母的术前焦虑评分也较低（P=0.10），但未达到显著差异。两组之间术后疼痛评分未观察到显著差异（P=0.54）。用户体验和满意度评估显示，儿童和父母都对CliniPup感到满意，并会向同龄人推荐这款游戏。
试点试验结果表明，CliniPup作为一种潜在有效的、有吸引力的辅助疗法，可减少接受门诊手术儿童的术前焦虑，对父母术前焦虑有积极影响的趋势。这些结果支持使用SERES框架来生成基于证据的SGH，从而为患者带来积极的健康结果。基于这些初步发现，我们提出了一项研究议程，以进一步开发和研究这个工具。
ClinicalTrials.gov NCT03874442；https://clinicaltrials.gov/ct2/show/NCT03874442（由WebCite存档于http://www.webcitation.org/78KZab8qc）
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