Intelligent Customer-driven Solution for Children and Their Parents Undergoing Day Surgery

Surgery Clinical Trial

Official title:

Intelligent Customer-driven Solution for Children and Their Parents Undergoing Children´s Day Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277299
• Other study ID #: HUS180/2020
• Status: Completed
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: February 3, 2022

Study information

• Verified date: February 2022
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research aims to evaluate the effectiveness of web-based mobile intervention (Icory -Solution) developed to pediatric patients and their parents in the pathway of outpatient surgery treatment in pre-intra- and postoperative setting: (1) Examine the effectiveness of the intervention on children's preoperative anxiety and fear, and postoperative pain (2) examine the effectiveness of the intervention on parental anxiety and satisfaction in children´s care path and (3) examine the experiences of the gamification in children in the intervention group.

Description:

Children and their families are entitled to know what is going to happen to them before undergoing day surgery and information must be based on the child's age and understanding. It is important to help children to cope with any upcoming surgery because the more anxious and fear they are, the more pain they experience after the day surgery. Digital gaming solutions could help families and children to be better oriented to the coming treatment. Icory -solution is a digital pathway for children and family and it contains a virtual tour to hospital and distraction games for children. The information on the application is aligned with the patient's individual needs based on the type of surgery and requirements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 3, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age between 7-12 years old
• 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:

• Cognitive and learning disabilities identified from the medical record
• A chronic illness and/or pain that required special medical care

Related Conditions & MeSH terms

• Children
• Herniorrhaphies
• Parents
• Surgery
• Tonsillitis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Finland	New Children´s Hospital	Helsinki

Sponsors (5)

Lead Sponsor	Collaborator
University of Oulu	Buddy Healthcare Ltd, Hospital District of Helsinki and Uusimaa, Tampere University, VTT Technical Research Centre of Finland

Country where clinical trial is conducted

Finland, 

References & Publications (17)

Abu-Saad H. Assessing children's responses to pain. Pain. 1984 Jun;19(2):163-71. — View Citation

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. — View Citation

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, 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

Spielberger CD (1983) Manual for the State-Trait Anxiety Inventory (STAI: Form Y). Palo Alto, CA: Consulting Psychologists Press, 1983:4-26

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mYPAS	Children's preoperative anxiety: Modified Yale Preoperative Anxiety Scale - (mYPAS-) Modified Yale Preoperative Anxiety Scale ( Kain et al 1997) will be used to measure the preoperative anxiety levels of the children right before the operation. It is a 4-item scale (activity, vocalization, emotional expressivity, state of apparent arousal) and it is filled in via observation. The total score ranges from 23 to 100. Higher scores mean higher levels of anxiety. A score of 31 and above would indicate high-anxiety.	mYPAS will be assessed at the baseline:(1)at the hospital on the day before the operation when nurse meets the child, and will assess changes between baseline and (2) before the induction and (3) one hour after operation when the child is awakening
Secondary	CPMAS	Children's Perioperative Multidimensional Anxiety Scale (CPMAS) developed by Chow et al. (2015) is a simple, age-appropriate self-report measure of pediatric perioperative anxiety and fear in busy hospital settings. The CPMAS is a visual analog scale composed of 5 items, each of which is scored from 0-100.	CPMAS will be assessed (1) one day before the operation at home, and will be assessed changes between baseline and (2) at the hospital before the operation and (3) before the induction and (4) days 1 and (5) 7 after the operation
Secondary	Children´s postoperative pain	VAS - The visual analogue scale (VAS) is a psychometric response scale to measure children´s postoperative pain. The scores range from 0-100 (Abu-Saad 1984) with a higher score means greater pain.	Children's postoperative pain will be measured at baseline (1) right after the operation and will be assessed changes between baseline (2) 24 hours,(3) days 3 and (4) 7 post-surgery
Secondary	STAI- Y	Parental anxiety Parental anxiety STAI- Y form will be used to measure parental anxiety using the State-Trait Anxiety Inventory (STAI-Y) which is a psychological inventory based on a 4-point Likert scale and consists of 20 questions on a self-report basis (Copyright © 1983 by Charles D. Spielberger)	Parents' preoperative anxiety will be assessed at baseline (1) at home on the day before the operation and will assess changes between baseline on the surgery day and (2) after the operation and (3) 24 hours after children´s day surgery
Secondary	Parental satisfaction: VAS	Parental satisfaction Satisfaction VAS (Reported satisfaction level by visual analog scales 1-10) 0 not at all satisfied 10 very satisfied	Parents' satisfaction on children´s day care path will be assessed at baseline (1) at home on the day and (2) on the surgery day after the operation and (3) 24 hours after children´s day surgery
Secondary	GAMEFULQUEST	Gamefulquest -instrument (Högberg et al. 2019) is a questionnaire for children in the intervention group to measure children´s experience playing the Triumf game. Gamefulquest is a 7-point Likert scale (1 totally disagree - 7 totally agree) concerning children's experience of playing the game in track record, immersion, challenge, playfulness and communal experience	Gamefulquest will be assessed 1 week after the operation