Dataset Information

A Web-Based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND: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. OBJECTIVE: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. METHODS: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. RESULTS: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. CONCLUSIONS: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. TRIAL REGISTRATION:ClinicalTrials.gov NCT03874442; https://clinicaltrials.gov/ct2/show/NCT03874442 (Archived by WebCite at http://www.webcitation.org/78KZab8qc).

SUBMITTER: Buffel C

PROVIDER: S-EPMC6592396 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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A Web-Based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial.

Buffel Connor C van Aalst June J Bangels Anne-Marie AM Toelen Jaan J Allegaert Karel K Verschueren Sarah S Vander Stichele Geert G

JMIR serious games 20190601 2

<h4>Background</h4>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.<h4>Objective</h4>The goal of the research was to clinically evaluate CliniPup as an adjunct therapy to existing pharmacological interventions aimed at reducing perioperative anxi ...[more]

PMID: 31199324

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Project description:BackgroundAn increasing number of children undergo ambulatory surgery each year, and a significant proportion experience substantial preoperative anxiety and postoperative pain. The management of perioperative anxiety and pain remains challenging in children and is inadequate, which negatively impacts the physical, psychosocial, and economic outcomes. Existing nonpharmacological interventions are costly, time consuming, vary in availability, and lack benefits. Therefore, there is a need for an evidence-based, accessible, nonpharmacological intervention as an adjunct to existing pharmacological alternatives to reduce perioperative anxiety and pain in children undergoing ambulatory surgery. Technology-enabled interventions have been proposed as a method to address the unmet need in this setting. In particular, serious games hold a unique potential to change health beliefs and behaviors in children.ObjectiveThe objective of this research was to describe the rationale, scientific evidence, design aspects, and features of CliniPup, a serious game aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery.MethodsThe SERES Framework for serious game development was used to create the serious game, CliniPup. In particular, we used a mixed methods approach that consisted of a structured literature review supplemented with ethnographic research, such as expert interviews and a time-motion exercise. The resulting scientific evidence base was leveraged to ensure that the resulting serious game was relevant, realistic, and theory driven. A participatory design approach was applied, wherein clinical experts qualitatively reviewed several versions of the serious game, and an iterative creative process was used to integrate the applicable feedback.ResultsCliniPup, a serious game, was developed to incorporate a scientific evidence base from a structured literature review, realistic content collected during ethnographic research such as expert interviews, explicit pedagogical objectives from scientific literature, and game mechanics and user interface design that address key aspects of the evidence.ConclusionsThis report details the systematic development of CliniPup, a serious game aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. Clinical experts validated CliniPup's underlying scientific evidence base and design foundations, suggesting that it was well designed for preliminary evaluation in the target population. An evaluation plan is proposed and briefly described.

Project description:BackgroundDepression is the most prevalent mental disorder, with detrimental effects on the patient's well-being, high disability, and a huge associated societal and economic cost. There are evidence-based treatments, but it is difficult to reach all people in need. Internet-based interventions, and more recently smartphone-based interventions, were explored to overcome barriers to access. Evidence shows them to be effective alternatives to traditional treatments. This paper presents the protocol of a pilot study whose primary aim is to investigate the efficacy of a smartphone-based serious game intervention for patients with mild to moderate depressive symptoms.MethodsThis randomized controlled pilot trial protocol foresees two arms design: 1/ smartphone- based serious game intervention (based on Cognitive Behavior Therapy with particular emphasis on Behavioral Activation and Physical Activity), 2/ waiting list control group. The study is expected to recruit 40 participants (18+), which will be randomly assigned to one of the experimental conditions. The duration of the intervention is two months. The primary outcome measure will be depressive symptomatology. Secondary outcomes will include other variables such as physical activity, resilience, anxiety, depression impairment, and positive and negative affect. Treatment expectation, satisfaction, usability, and game playability will also be measured. The data will be analyzed based on the intention-to-treat and per protocol analyses.DiscussionThe study aims to establish initial evidence for the efficacy of a smartphone-based serious game intervention, to serve as input for a larger-scale randomized control trial. The intervention exploits advanced smartphone capabilities, such as the use of a serious game as delivery mode, with the potential benefit of engagement and treatment adherence, and motion sensors to monitor and stimulate physical activity. As a secondary objective, the study aims to gather initial evidence on the user's expectations, satisfaction, usability and playability of the serious game as a treatment.

Project description:BACKGROUND:Developmental disabilities are a set of heterogeneous delays or difficulties in one or more areas of neuropsychological development. Considering that childhood is an essential stage of brain development and developmental delays lead to personal or social burdens, the early detection of childhood developmental disabilities is important. However, early screening for developmental disabilities has been a challenge because of the fear of positive results, expensive tests, differences in diagnosis depending on examiners' abilities, and difficulty in diagnosis arising from the need for long-term follow-up observation. OBJECTIVE:This study aimed to assess the feasibility of using a serious game-derived index to identify heterogeneous developmental disabilities. This study also examines the correlation between the game-derived index and existing neuropsychological test results. METHODS:The randomized controlled trial involved 48 children with either normal development or developmental disabilities. In this clinical trial, we used 19 features (6 from the Korean-Wechsler Preschool and Primary Scale of Intelligence, 8 from the Psychoeducational Profile Revised, 2 from the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, and 3 from the Pediatric Evaluation of Disability Inventory) from neuropsychological tests and 9 (7 game scores, path accuracy, and completion rate) from the serious game, DoBrain. The following analysis was conducted based on participants' baseline information and neuropsychological test and game-derived index data for one week: (1) we compared the baseline information between the normal development and developmental disabilities groups; (2) then we measured the correlation between the game-derived index and the neuropsychological test scores for each group; and (3) we built a classifier based on the game-derived index with a Gaussian process method and then compared the area under the curve (AUC) with a model based on neuropsychological test results. RESULTS:A total of 16 children (normal development=9; developmental disabilities=7) were analyzed after selection. Their developmental abilities were assessed before they started to play the serious games, and statistically significant differences were found in both groups. Specifically, the normal development group was more developed than the developmental disabilities group in terms of social function, gross motor function, full-scale IQ, and visual motor imitation, in that order. Similarly, the normal development group obtained a higher score on the game-derived index than the developmental disabilities group. In the correlation analysis between the game-derived index and the neuropsychological tests, the normal development group showed greater correlation with more variables than the developmental disabilities group. The game-derived index-based model had an AUC=0.9, a similar detection value as the neuropsychological test-based model's AUC=0.86. CONCLUSIONS:A game-derived index based on serious games can detect children with heterogenous developmental disabilities. This suggests that serious games can be used as a potential screening tool for developmental disabilities. TRIAL REGISTRATION:Clinical Research Information Service KCT0003247; https://cris.nih.go.kr/cris/en/search/search_result_st01 .jsp?seq=12365.

Project description:IntroductionCurrent clinical applications of virtual reality (VR) provide patients with transient pain relief during acutely painful events by redirecting attention. Biofeedback (BF) is a mind-body therapy that effectively produces sustained pain reduction, but there are obstacles to its routine use. Combined, BF-based VR (VR-BF) may increase accessibility while enhancing the benefits of BF. VR-BF has yet to be employed in perioperative care, and as such, no defined treatment protocol for VR-BF exists. The primary aim of this study is to assess the feasibility of the perioperative use of VR-BF in children and adolescents. The secondary aims are to assess the acceptability of VR-BF and to collect pilot efficacy data.Methods and analysisThis is a single-centre, randomised controlled pilot clinical trial. A total of 70 patients (12-18 years) scheduled for surgery anticipated to cause moderate to severe pain with ≥1 night of hospital admission will be randomised to one of two study arms (VR-BF or control). Participants randomised to VR-BF (n=35) will use the ForeVR VR platform to engage their breathing in gamified VR applications. Participants randomised to control (n=35) will interact with a pain reflection app, Manage My Pain. The primary outcome is feasibility of VR-BF use in adolescents undergoing surgery as assessed through recruitment, enrolment, retention and adherence to the protocol. Secondary outcomes are acceptability of VR-BF and pilot efficacy measures, including pain, anxiety and opioid consumption.Ethics and disseminationThe protocol was approved by the Nationwide Children's Hospital Institutional Review Board (IRB #STUDY00002080). Patient recruitment begins in March 2023. Written informed consent is obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals. Data will be available per request and results will be posted on ClinicalTrials.gov.Trial registration numberClinicalTrials.gov Registry (NCT04943874).

Project description:BackgroundIn the United States, the most common sexually transmitted infection, human papillomavirus (HPV), causes genital warts and is associated with an estimated 33,700 newly diagnosed cancer cases annually. HPV vaccination, especially for preteens aged 11 to 12 years, is effective in preventing the acquisition of HPV and HPV-associated cancers. However, as of 2018, completion of the 2- or 3-dose HPV vaccination series increased only from 48.6% to 51.1% in teens aged 13 to 17 years, and this increase was observed only in boys. By comparison, 88.7% of teens had more than one dose of the recommended vaccine against tetanus, diphtheria, and acellular pertussis (Tdap), and 85.1% of teens had more than one dose of meningococcal vaccine. Immunizations for Tdap, meningococcal disease, and HPV can occur at the same clinical visit but often do not.ObjectiveVaccination against HPV is recommended for routine use in those aged 11 to 12 years in the United States, yet it is underutilized. We aimed to develop an educational video game to engage preteens in the decision to vaccinate.MethodsLand of Secret Gardens is a metaphor for protecting seedlings (body) with a potion (vaccine). We screened 131 dyads of parents and preteens from 18 primary practices in North Carolina who had not initiated HPV vaccination. We measured vaccination intentions, story immersion, and game play and documented HPV vaccination rates. A total of 55 dyads were enrolled, and we randomly assigned 28 (21 completed) to play the game and 27 (26 completed) to the comparison group.ResultsIn total, 18 preteens reported playing the game. The vaccination self-efficacy score was higher in the comparison group than the intervention group (1.65 vs 1.45; P=.05). The overall mean decisional balance score trended toward greater support of vaccination, although differences between the groups were not significant.. Vaccine initiation and completion rates were higher in the intervention group (22% vs 15%; P=.31) than in the comparison group (9% vs 2%; P=.10), although the difference was not significant.ConclusionsVideo games help preteens in the decision to pursue HPV vaccination. A serious video game on HPV vaccination is acceptable to parents and preteens and can be played as intended. Gamification is effective in increasing preteen interest in HPV vaccination, as game features support decision making for HPV vaccination.Trial registrationClinicalTrials.gov NCT04627298; https://www.clinicaltrials.gov/ct2/show/NCT04627298.

Dataset Information

A Web-Based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial.

Publications

A Web-Based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial.

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