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

Connor Buffel, June van Aalst, Anne-Marie Bangels, Jaan Toelen, Karel Allegaert, Sarah Verschueren, Geert Vander Stichele, Connor Buffel, June van Aalst, Anne-Marie Bangels, Jaan Toelen, Karel Allegaert, Sarah Verschueren, Geert Vander Stichele

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://ichgcp.net/clinical-trials-registry/NCT03874442 (Archived by WebCite at http://www.webcitation.org/78KZab8qc).

Keywords: ambulatory surgery; behavior change; pediatric; perioperative anxiety; perioperative pain; serious games for health.

Conflict of interest statement

Conflicts of Interest: SV is a paid consultant for MindBytes, GVS is the founder and CEO of MindBytes and MindLab Interactive AI Inc, and CB is an employee of MindLab Interactive AI Inc and previously served as a paid consultant for MindBytes. JVA, AMB, JT, and KA declare no competing financial interests.

©Connor Buffel, June van Aalst, Anne-Marie Bangels, Jaan Toelen, Karel Allegaert, Sarah Verschueren, Geert Vander Stichele. Originally published in JMIR Serious Games (http://games.jmir.org), 01.06.2019.

Figures

Figure 1
Figure 1
Study design flowchart. STAI: State-Trait Anxiety Inventory; mYPAS: modified Yale Preoperative Anxiety Scale; WBFPRS: Wong-Baker Faces Pain Rating Scale.
Figure 2
Figure 2
Patient flow diagram.
Figure 3
Figure 3
Child preoperative anxiety. mYPAS: modified Yale Preoperative Anxiety Scale.
Figure 4
Figure 4
Child postoperative pain. WBFPR: Wong-Baker Faces Pain Rating Scale.
Figure 5
Figure 5
Parental preoperative anxiety. STAI: State-Trait Anxiety Inventory.

References

    1. Walther-Larsen S, Aagaard GB, Friis SM, Petersen T, Møller-Sonnergaard J, Rømsing J. Structured intervention for management of pain following day surgery in children. Paediatr Anaesth. 2016 Feb;26(2):151–157. doi: 10.1111/pan.12811.
    1. Litke J, Pikulska A, Wegner T. Management of perioperative stress in children and parents. Part I: the preoperative period. Anaesthesiol Intensive Ther. 2012;44(3):165–169.
    1. Rabbitts JA, Groenewald CB, Moriarty JP, Flick R. Epidemiology of ambulatory anesthesia for children in the United States: 2006 and 1996. Anesth Analg. 2010 Oct;111(4):1011–1015. doi: 10.1213/ANE.0b013e3181ee8479.
    1. Perrott C, Lee C, Griffiths S, Sury MRJ. Perioperative experiences of anesthesia reported by children and parents. Paediatr Anaesth. 2018 Dec;28(2):149–156. doi: 10.1111/pan.13300.
    1. Linton SJ, Shaw WS. Impact of psychological factors in the experience of pain. Phys Ther. 2011 May;91(5):700–711. doi: 10.2522/ptj.20100330.
    1. Fortier MA, Kain ZN. Treating perioperative anxiety and pain in children: a tailored and innovative approach. Paediatr Anaesth. 2015 Jan;25(1):27–35. doi: 10.1111/pan.12546.
    1. Banchs RJ, Lerman J. Preoperative anxiety management, emergence delirium, and postoperative behavior. Anesthesiol Clin. 2014 Mar;32(1):1–23. doi: 10.1016/j.anclin.2013.10.011.
    1. Khan KA, Weisman SJ. Nonpharmacologic pain management strategies in the pediatric emergency department. Clin Pediatr Emerg Med. 2007 Dec;8(4):240–247. doi: 10.1016/j.cpem.2007.08.008.
    1. Perry JN, Hooper VD, Masiongale J. Reduction of preoperative anxiety in pediatric surgery patients using age-appropriate teaching interventions. J Perianesth Nurs. 2012 Apr;27(2):69–81. doi: 10.1016/j.jopan.2012.01.003.
    1. Copanitsanou P, Valkeapää K. Effects of education of paediatric patients undergoing elective surgical procedures on their anxiety: a systematic review. J Clin Nurs. 2014 Apr;23(7-8):940–954. doi: 10.1111/jocn.12187.
    1. Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015 Apr;95(2):301–318. doi: 10.1016/j.suc.2014.10.002.
    1. Fletcher MC, Spera JF. Management of acute postoperative pain after oral surgery. Dent Clin North Am. 2012 Jan;56(1):95–111. doi: 10.1016/j.cden.2011.09.001.
    1. Howard D, Davis KF, Phillips E, Ryan E, Scalford D, Flynn-Roth R, Ely E. Pain management for pediatric tonsillectomy: an integrative review through the perioperative and home experience. J Spec Pediatr Nurs. 2014 Jan;19(1):5–16. doi: 10.1111/jspn.12048.
    1. Lauder G, Emmott A. Confronting the challenges of effective pain management in children following tonsillectomy. Int J Pediatr Otorhinolaryngol. 2014 Nov;78(11):1813–1827. doi: 10.1016/j.ijporl.2014.08.011.
    1. Girard P, Chauvin M, Verleye M. Nefopam analgesia and its role in multimodal analgesia: a review of preclinical and clinical studies. Clin Exp Pharmacol Physiol. 2016 Jan;43(1):3–12. doi: 10.1111/1440-1681.12506.
    1. Finley GA, McGrath PJ, Forward SP, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83–87.
    1. Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239–248. doi: 10.1111/pan.12327.
    1. Fortier MA, MacLaren JE, Martin SR, Perret-Karimi D, Kain ZN. Pediatric pain after ambulatory surgery: where's the medication? Pediatrics. 2009 Oct;124(4):e588–e595. doi: 10.1542/peds.2008-3529.
    1. Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217–1223. doi: 10.1111/pan.12475.
    1. Bul KCM, Kato PM, Van der Oord S, Danckaerts M, Vreeke LJ, Willems A, van Oers HJJ, Van Den Heuvel R, Birnie D, Van Amelsvoort TAMJ, Franken IHA, Maras A. Behavioral outcome effects of serious gaming as an adjunct to treatment for children with attention-deficit/hyperactivity disorder: a randomized controlled trial. J Med Internet Res. 2016 Feb 16;18(2):e26. doi: 10.2196/jmir.5173.
    1. Kato PM, Cole SW, Bradlyn AS, Pollock BH. A video game improves behavioral outcomes in adolescents and young adults with cancer: a randomized trial. Pediatrics. 2008 Aug;122(2):e305–e317. doi: 10.1542/peds.2007-3134.
    1. De Queiroz Siqueira M, Tosseti S, Maréchal C, Cogniat B, Berthilier J, Chassard D. Abstract PR237: Effect of iPad tablet on children and parental anxiety during anesthesia. Anesth Analg. 2016;123:308–309. doi: 10.1213/.
    1. Verschueren S, Van Aalst J, Bangels AM, Toelen J, Allegaert K, Buffel C, Vander Stichele G. Development of Clinipup, a serious game aimed at reducing perioperative anxiety and pain in children: mixed methods study. JMIR Serious Games. 2019 doi: 10.2196/12429.
    1. McCann ME, Kain ZN. The management of preoperative anxiety in children: an update. Anesth Analg. 2001 Jul;93(1):98–105.
    1. Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a gold standard? Anesth Analg. 1997 Oct;85(4):783–788.
    1. Wilson M, Helgadóttir H. Patterns of pain and analgesic use in 3- to 7-year-old children after tonsillectomy. Pain Manag Nurs. 2006;7:159–166.
    1. Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651–658. doi: 10.1542/peds.2005-2920.
    1. Spielberger C. State-Trait Anxiety Inventory for Adults: Manual. Menlo Park: Mind Garden; 1983.
    1. Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A) Arthritis Care Res (Hoboken) 2011 Nov;63 Suppl 11:S467–S472. doi: 10.1002/acr.20561. doi: 10.1002/acr.20561.
    1. Rekhi S. A Practitioner's Guide to Net-Promoter Score (NPS) [2018-10-05]. .
    1. Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007 Jan;31(1):52–79. doi: 10.1177/0145445506295055.
    1. Taber JM, Leyva B, Persoskie A. Why do people avoid medical care? A qualitative study using national data. J Gen Intern Med. 2015 Mar;30(3):290–297. doi: 10.1007/s11606-014-3089-1.
    1. Young KD. Pediatric procedural pain. Ann Emerg Med. 2005 Feb;45(2):160–171. doi: 10.1016/j.annemergmed.2004.09.019.
    1. Verschueren S, Buffel C, Vander Stichele G. Developing theory-driven, evidence-based serious games for health: framework based on research community insights. JMIR Serious Games. 2019 May 02;7(2):e11565. doi: 10.2196/11565.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere