Intelligent Customer-driven Solution for Children and Their Parents Undergoing Day Surgery
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|ClinicalTrials.gov Identifier: NCT04277299|
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tonsillitis Herniorrhaphies Surgery Children Parents||Device: IcorySolution||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Intelligent Customer-driven Solution for Children and Their Parents Undergoing Children´s Day Surgery|
|Actual Study Start Date :||August 12, 2020|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||November 15, 2021|
Experimental: 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.
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.
No Intervention: 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.
- mYPAS [ 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 ]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.
- CPMAS [ 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 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.
- Children´s postoperative 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 ]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.
- STAI- Y [ 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 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)
- Parental satisfaction: VAS [ 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 ]Parental satisfaction Satisfaction VAS (Reported satisfaction level by visual analog scales 1-10) 0 not at all satisfied 10 very satisfied
- GAMEFULQUEST [ Time Frame: Gamefulquest will be assessed 1 week after the operation ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277299
|Contact: Arja Rantalaemail@example.com|
|Contact: Pekka Lahdennefirstname.lastname@example.org|
|New Children´s Hospital||Recruiting|
|Contact: Pekka Lahdenne +3584285521 email@example.com|
|Contact: Minna Pikkarainen +358047539880|
|Principal Investigator: Pekka Lahdenne|
|Principal Investigator:||Pekka Lahdenne||New Children´s Hospital|