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Development of CliniPup, a Serious Game Aimed at Reducing Perioperative Anxiety and Pain in Children: Mixed Methods Study.

ABSTRACT:

Background

An 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.

Objective

The 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.

Methods

The 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.

Results

CliniPup, 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.

Conclusions

This 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.

SUBMITTER: Verschueren S

PROVIDER: S-EPMC6592492 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Development of CliniPup, a Serious Game Aimed at Reducing Perioperative Anxiety and Pain in Children: Mixed Methods Study.

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

JMIR serious games 20190601 2

<h4>Background</h4>An 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 ...[more]

PMID: 31199333

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Project description:BackgroundAs 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.ObjectiveThe 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.MethodsCliniPup 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.ResultsDespite 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.ConclusionsResults 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 registrationClinicalTrials.gov NCT03874442; https://clinicaltrials.gov/ct2/show/NCT03874442 (Archived by WebCite at http://www.webcitation.org/78KZab8qc).

Project description:BACKGROUND:Although teen pregnancy rates decreased dramatically in the United States over the past decade, the rates of sexually transmitted infections (STIs) among adolescents and young adults increased. STI rates disproportionately affect African American youth and young adults. Innovative, accessible, and culturally relevant sexual health interventions are urgently needed. OBJECTIVE:This study aimed to identify the optimal modality for a game-based sexual health intervention; develop the educational, entertainment, and technological aspects of the serious game; and demonstrate its usability and acceptance by the target population. METHODS:This project was grounded in formative data collection with community-based participatory research principles and practices combined with a user-centered design and development approach. Sexually Active Adolescent-Focused Education (SAAFE) was developed using input and feedback from African American youths aged 15 to 21 years who participated in a youth advisory board and focus group discussions to inform the co-design and cocreation of the serious game. The process was highly iterative with multiple sessions for user input following design changes. It proceeded in 3 stages. Social cognitive theory and problem-solving theory were leveraged to provide evidence-based, trauma-informed education through a serious game. Usability testing assessed the quality of user experience with the prototype. RESULTS:Across all 3 stages, a total of 86 self-identified African American males and females aged 15 to 21 years from the District of Columbia and Birmingham, Alabama, participated. Participants requested a dating simulation game. They wanted SAAFE to be customizable, realistic, entertaining, educational, modern, and experiential, linking consequences to their gameplay decisions. Usability testing resulted in an initial System Usability Survey score of 77.7, placing the game in the 82nd percentile and above average for usability. CONCLUSIONS:Initial results suggest that the SAAFE prototype is a promising intervention to engage African American youth in sexual health education using a role-playing game. If proven efficacious, the game has the potential to meet the need for sex education, counterbalance unhealthy portrayals of sex in popular media, and respond to the disparities in the STI epidemic.

Project description:BackgroundPreschool-aged children with acute lymphoblastic leukemia (ALL) receive long-term treatment according to the Taiwan Pediatric Oncology Group (TPOG)-ALL 2013 protocol. Severe anxiety and noncompliance ahead of frequent invasive therapies leads to an increase in health care costs. Previous studies have shown that therapeutic video games (TVGs) can decrease the anxiety experienced by children who are ill. To our knowledge, no existing TVG has been designed specifically for preschool-aged children with ALL in Taiwan.ObjectiveThe purpose of this study was to develop a TVG using the popular Mechanics, Dynamics, and Aesthetics (MDA) framework for game design and to investigate the effect of this TVG on the reduction of therapy-related anxiety among preschool-aged children with ALL.MethodsThis study used a mixed methods approach over three phases: (1) develop a TVG using the MDA framework, (2) test the reliability of the TVG among three certified children's art therapists, and (3) evaluate the reduction of therapy-related anxiety among participants after using the TVG for 6 weeks, using a two-group, stratified randomized controlled trial at a medical center in northern Taiwan. Eligible preschool-aged children with ALL were randomly assigned 1:1 into an experimental group or a control group. The two groups of subjects received the same usual care, and only the experimental group had access to and used the TVG. The children's anxiety responses were reported by their family caregivers using the face rating scale (FRS). Descriptive analyses, the Fisher exact test, the Pearson chi-square test, and the Mann-Whitney U test were used to statistically analyze the variables.ResultsSix mechanics rules supported the dynamics of the TVG using four main features-character, nursery, tasks, and market-in order to complete all of the therapy-related anxiety reduction scenarios and to achieve eight aesthetics goals. The results of reliability test showed that participants found the TVG to be useful and trustworthy for preschool-aged children with ALL (Cronbach α=.98). A total of 15 participants were enrolled and randomly allocated to the experimental group (n=7) or the control group (n=8). The average number of TVG log-ins was 37.9 (SD 15.30, range 14-62) in the experimental group. The demographic data showed homogeneity across the two groups regarding age (3 to 5 years), sex (male), risk classification (standard risk), and treatment status (continuation therapy). The mean FRS score was 6.16 (SD 3.31) for the experimental group as compared to 7.45 (SD 2.71) for the control group (P=.04), which represented a significant difference between the groups at the 6-week follow-up.ConclusionsThis research provides evidence that using a TVG can decrease anxiety in preschool-aged children with ALL in Taiwan. The TVG could be used to support clinical professionals before they perform invasive therapies. However, it is recommended to increase the statistical power for inference.Trial registrationClinicalTrials.gov NCT04199637; https://www.clinicaltrials.gov/ct2/show/NCT04199637.

Project description:BACKGROUND:History taking is a key component of clinical practice; however, this skill is often poorly performed by students and doctors. OBJECTIVE:The study aimed to determine whether Metaphoria, a 3D serious game (SG), is superior to another electronic medium (PDF text file) in learning the history-taking content of a single organ system (cardiac). METHODS:In 2015, a longitudinal mixed methods (quantitative and qualitative) pilot study was conducted over multiple sampling time points (10 weeks) on a group of undergraduate medical students at The University of Auckland Medical School, New Zealand. Assessors involved in the study were blinded to group allocation. From an initial sample of 83, a total of 46 medical students were recruited. Participants were assigned to either a PDF group (n=19) or a game group (n=27). In total, 1 participant left the PDF group after allocation was revealed and was excluded. A total of 24 students in the game group and 14 students in the PDF group completed follow-up 7 weeks later. Using an iterative design process for over a year, with input from a variety of clinical disciplines, a cardiac history-taking game and PDF file were designed and informed by Cognitive Load Theory. Each group completed its intervention in 40 min. A total of 3 levels of Kirkpatrick training evaluation model were examined using validated questionnaires: affective (perception and satisfaction), cognitive (knowledge gains and cognitive load), and behavioral attitudes (Objective Structured Clinical Exam) as well as qualitative assessment. A priori hypotheses were formulated before data collection. RESULTS:Compared with baseline, both groups showed significant improvement in knowledge and self-efficacy longitudinally (P<.001). Apart from the game group having a statistically significant difference in terms of satisfaction (P<.001), there were no significant differences between groups in knowledge gain, self-efficacy, cognitive load, ease of use, acceptability, or objective structured clinical examination scores. However, qualitative findings indicated that the game was more engaging and enjoyable, and it served as a visual aid compared with the PDF file. CONCLUSIONS:Students favored learning through utilization of an SG with regard to cardiac history taking. This may be relevant to other areas of medicine, and this highlights the importance of innovative methods of teaching the next generation of medical students.

Project description:ObjectivesTo generate a conceptual framework describing what is done to reduce the impact of chronic tinnitus on the lives of children and adolescents.DesignViews and experiences of 32 adults from two participant groups informed this concept mapping study: (i) a tinnitus group (adults who experienced tinnitus during childhood/adolescence, and primary carers of children/adolescents with tinnitus) and (ii) a clinicians' group (clinicians who provided care for children/adolescents with tinnitus). Participants produced statements describing what is done to reduce the impact of chronic tinnitus on the lives of children and adolescents who experience it. Through grouping and rating processes, they identified key concepts and inferred their associated benefit.ResultsThe participants generated 102 unique statements across four concepts: (1) Education, Support, and Counselling; (2) Support from Parents and Teachers; (3) Clinical Assessments and Management; and (4) Self-Management Techniques. Many statements highlighted the need for child-friendly and patient-centred care. Adults with personal experience of childhood tinnitus tended to perceive many of the statements as more beneficial than did the clinician group.ConclusionsAlthough many children will develop management strategies to assist them with their tinnitus, both the adults who experienced tinnitus as children and their parents valued strategies involving clinical care, knowledge, and expertise. Participants from the tinnitus group perceived a greater degree of benefit associated with strategies from all four clusters than the clinicians' group. However, both groups perceived the greatest degree of benefit as being associated with activities and strategies within the Education, Support, and Counselling and the Clinical Assessments and Management clusters. Both groups identified that recognising the occurrence of tinnitus for children and adolescents, acknowledging the potential for associated distress, and initiating clinical care provide the nexus of effective management. Addressing the concerns and needs of parents was also perceived as valuable; hence, approaching the management of tinnitus during childhood and adolescence from a family-centred care framework is recommended.

Project description:BACKGROUND:Serious gaming could support patients in learning to cope with chronic pain or functional somatic syndromes and reduce symptom burdens. OBJECTIVE:To realize this potential, insight is needed into how, why, for whom, and when it works in actual treatment circumstances. METHODS:Following a realist approach, process evaluations were performed before, during, and after a two-armed, natural quasi-experiment (n=275). A group of patients with interfering chronic pain or fatigue symptoms received a short additional blended mindfulness-based serious gaming intervention during a multidisciplinary rehabilitation program. A control group only received the regular rehabilitation program. During two sessions before and one session after the experiment, expectations about serious gaming processes were discussed in focus groups with local care providers, implementers, and experts. Patients participated in a survey (n=114) and in semistructured interviews (n=10). The qualitative data were used to develop tentative expectations about aspects of serious gaming that, in certain patients and circumstances, trigger mechanisms of learning and health outcome change. Hypotheses about indicative quantitative data patterns for tentative expectations were formulated before inspecting, describing, and analyzing-with regression models-routinely collected clinical outcome data. An updated program theory was formulated after mixing the qualitative and quantitative results. RESULTS:Qualitative data showed that a subset of patients perceived improvement of their self-awareness in moments of daily social interactions. These results were explained by patients, who played the serious game LAKA, as a "confrontation with yourself," which reflected self-discrepancies. Important characteristics of serious gaming in the study's context included innovation factors of relative advantage with experiential learning opportunity, compatibility with the treatment approach, and the limited flexibility in regard to patient preferences. Perceived patient factors included age and style of coping with stress or pain. Learning perceptions could also depend on care provider role-taking and the planning and facilitating (ie, local organization) of serious gaming introduction and feedback sessions in small groups of patients. Quantitative data showed very small average differences between the study groups in self-reported depression, pain, and fatigue changes (-.07<beta<-.17, all 95% CI upper bounds <0), which were mediated by small group differences in mindfulness (beta=.26, 95% CI .02-.51). Mindfulness changes were positively associated with patient involvement in serious gaming (n=114, beta=.36, P=.001). Acceptance of serious gaming was lower in older patients. Average health outcome changes went up to a medium size in patients that reported lower active coping with stress and lower pain coping before serious gaming. Mindfulness changes and gaming acceptance perceptions covaried with group structure and immediate feedback sessions after serious gaming. CONCLUSIONS:This study developed transferable insight into how and why serious gaming can facilitate additional learning about coping in order to reduce burdens of chronic pain or fatigue symptoms in certain patients and in actual treatment circumstances. Future studies are needed to continue the development of this fallible theory. Such research will further support decisions about using, designing, allocating, and tailoring serious gaming to optimize important patient health benefits. TRIAL REGISTRATION:Netherlands Trial Register NTR6020; https://www.trialregister.nl/trial/5754.

Dataset Information

Development of CliniPup, a Serious Game Aimed at Reducing Perioperative Anxiety and Pain in Children: Mixed Methods Study.

Background

Objective

Methods

Results

Conclusions

Publications

Development of CliniPup, a Serious Game Aimed at Reducing Perioperative Anxiety and Pain in Children: Mixed Methods Study.

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