An interventional study of IcorySolution in Tonsillitis, Herniorrhaphies and Surgery, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by University of Oulu · Not applicable, Interventional, and Health services research
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.
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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.
Device: IcorySolution
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.
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.
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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)
Time frame: 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
Parental satisfaction: VAS
Parental satisfaction Satisfaction VAS (Reported satisfaction level by visual analog scales 1-10) 0 not at all satisfied 10 very satisfied
Time frame: 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
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
Time frame: Gamefulquest will be assessed 1 week after the operation
Plan to share: No — Due to GDPR in Finland, we doesn't plan to share data to public
Ran from Aug 2020 to primary completion in Aug 2021, 12 months.
Of 29 non-industry interventional studies with no phase under Tonsillitis, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 49. This study's 12 months is below that.
Counting every sponsor, half of 29 studies reached it within 20 months; a quarter within 10 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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