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NCT Number: NCT04277299

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

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.

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Key information

Conditions

Tonsillitis Children Herniorrhaphies Infections Otorhinolaryngologic Diseases Parents Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Surgery

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Children´s Hospital

Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IcorySolution

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Buddy Healthcare Ltd
  • Hospital District of Helsinki and Uusimaa
  • Tampere University
  • VTT Technical Research Centre of Finland

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 20, 2020
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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