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

Primary Purpose

Tonsillitis, Herniorrhaphies, Surgery

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
IcorySolution
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tonsillitis

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Children´s Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)
Parental satisfaction: VAS
Parental satisfaction Satisfaction VAS (Reported satisfaction level by visual analog scales 1-10) 0 not at all satisfied 10 very satisfied
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

Full Information

First Posted
February 10, 2020
Last Updated
February 3, 2022
Sponsor
University of Oulu
Collaborators
VTT Technical Research Centre of Finland, Hospital District of Helsinki and Uusimaa, Tampere University, Buddy Healthcare Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04277299
Brief Title
Intelligent Customer-driven Solution for Children and Their Parents Undergoing Day Surgery
Official Title
Intelligent Customer-driven Solution for Children and Their Parents Undergoing Children´s Day Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
Collaborators
VTT Technical Research Centre of Finland, Hospital District of Helsinki and Uusimaa, Tampere University, Buddy Healthcare Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis, Herniorrhaphies, Surgery, Children, Parents

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IcorySolution
Intervention Description
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.
Primary Outcome Measure Information:
Title
mYPAS
Description
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
Secondary Outcome Measure Information:
Title
CPMAS
Description
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
Title
Children´s postoperative pain
Description
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
Title
STAI- Y
Description
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
Title
Parental satisfaction: VAS
Description
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
Title
GAMEFULQUEST
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pekka Lahdenne
Organizational Affiliation
New Children´s Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Children´s Hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to GDPR in Finland, we doesn't plan to share data to public
Citations:
PubMed Identifier
28661955
Citation
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Results Reference
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Citation
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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.
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Citation
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Citation
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Intelligent Customer-driven Solution for Children and Their Parents Undergoing Day Surgery

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