Intelligent Customer-driven Solution for Children and Their Parents Undergoing Day Surgery
NCT ID: NCT04277299
Last Updated: 2022-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-08-12
2022-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Intervention group
The participants in the intervention group will receive the routine care plus the ICory-Solution which is the surgical pathway currently practiced in the study hospital. The ICory-Solution has two components: (1) the Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support and distraction to children.
IcorySolution
The ICory-solution programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery. The healthcare professional have received face-to-face training on how to use the BuddyCare dashboard and BuddyCare has been in the hospital in earlier studies.The Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support, games and distraction to children and a virtual tour to the hospital before children´s operation.
Control group
Children in the control group will receive routine care provided by the hospital which consists of normal doctor consultant, preoperative preparation, and postoperative care. Parents in this group will receive BuddyCare mobile app which is supposed to be as a normal routine in this hospital.
No interventions assigned to this group
Interventions
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IcorySolution
The ICory-solution programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery. The healthcare professional have received face-to-face training on how to use the BuddyCare dashboard and BuddyCare has been in the hospital in earlier studies.The Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support, games and distraction to children and a virtual tour to the hospital before children´s operation.
Eligibility Criteria
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Inclusion Criteria
* Is scheduled for an elective day surgery
* Is able to speak, and read in Finnish
* Is accompanied by their parents (either mother or father or both) during the perioperative period
* Has access to smart phone/tablet (own or rent from the project)
Exclusion Criteria
* A chronic illness and/or pain that required special medical care
7 Years
12 Years
ALL
No
Sponsors
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VTT Technical Research Centre of Finland
OTHER
Hospital District of Helsinki and Uusimaa
OTHER
Tampere University
OTHER
Buddy Healthcare Ltd
UNKNOWN
University of Oulu
OTHER
Responsible Party
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Principal Investigators
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Pekka Lahdenne
Role: PRINCIPAL_INVESTIGATOR
New Children´s Hospital
Locations
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New Children´s Hospital
Helsinki, , Finland
Countries
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References
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Chow CHT, Van Lieshout RJ, Schmidt LA, Buckley N. Tablet-Based Intervention for Reducing Children's Preoperative Anxiety: A Pilot Study. J Dev Behav Pediatr. 2017 Jul/Aug;38(6):409-416. doi: 10.1097/DBP.0000000000000454.
Abu-Saad H. Assessing children's responses to pain. Pain. 1984 Jun;19(2):163-71. doi: 10.1016/0304-3959(84)90836-4.
Högberg, J., Hamari, J., & Wästlund, E. (2019). Gameful Experience Questionnaire (GAMEFULQUEST): an instrument for measuring the perceived gamefulness of system use. User Modeling and User-Adapted Interaction, 1-42.
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):783-8. doi: 10.1097/00000539-199710000-00012.
Spielberger CD (1983) Manual for the State-Trait Anxiety Inventory (STAI: Form Y). Palo Alto, CA: Consulting Psychologists Press, 1983:4-26
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):651-8. doi: 10.1542/peds.2005-2920.
Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.
Kim H, Jung SM, Yu H, Park SJ. Video Distraction and Parental Presence for the Management of Preoperative Anxiety and Postoperative Behavioral Disturbance in Children: A Randomized Controlled Trial. Anesth Analg. 2015 Sep;121(3):778-784. doi: 10.1213/ANE.0000000000000839.
Lee JH, Jung HK, Lee GG, Kim HY, Park SG, Woo SC. Effect of behavioral intervention using smartphone application for preoperative anxiety in pediatric patients. Korean J Anesthesiol. 2013 Dec;65(6):508-18. doi: 10.4097/kjae.2013.65.6.508. Epub 2013 Dec 26.
Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1.
Marechal C, Berthiller J, Tosetti S, Cogniat B, Desombres H, Bouvet L, Kassai B, Chassard D, de Queiroz Siqueira M. Children and parental anxiolysis in paediatric ambulatory surgery: a randomized controlled study comparing 0.3 mg kg-1 midazolam to tablet computer based interactive distraction. Br J Anaesth. 2017 Feb;118(2):247-253. doi: 10.1093/bja/aew436.
Messeri A, Caprilli S, Busoni P. Anaesthesia induction in children: a psychological evaluation of the efficiency of parents' presence. Paediatr Anaesth. 2004 Jul;14(7):551-6. doi: 10.1111/j.1460-9592.2004.01258.x.
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.
Pope N, Tallon M, McConigley R, Leslie G, Wilson S. Experiences of acute pain in children who present to a healthcare facility for treatment: a systematic review of qualitative evidence. JBI Database System Rev Implement Rep. 2017 Jun;15(6):1612-1644. doi: 10.11124/JBISRIR-2016-003029.
Niemelä, R., Pikkarainen, M., Ervasti, M., & Reponen, J. (2019). The change of pediatric surgery practice due to the emergence of connected health technologies. Technological Forecasting and Social Change, 146, 352-365. https://doi.org/10.1016/j.techfore.2019.06.001
Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, 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):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.
Stewart B, Cazzell MA, Pearcy T. Single-Blinded Randomized Controlled Study on Use of Interactive Distraction Versus Oral Midazolam to Reduce Pediatric Preoperative Anxiety, Emergence Delirium, and Postanesthesia Length of Stay. J Perianesth Nurs. 2019 Jun;34(3):567-575. doi: 10.1016/j.jopan.2018.08.004. Epub 2018 Nov 7.
Rantala A, Vuorinen AL, Koivisto J, Simila H, Helve O, Lahdenne P, Pikkarainen M, Haljas K, Polkki T. A gamified mobile health intervention for children in day surgery care: Protocol for a randomized controlled trial. Nurs Open. 2022 Mar;9(2):1465-1476. doi: 10.1002/nop2.1143. Epub 2021 Dec 2.
Other Identifiers
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HUS180/2020
Identifier Type: -
Identifier Source: org_study_id
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