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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04277299
Recruitment Status : Not yet recruiting
First Posted : February 20, 2020
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
VTT Technical Research Centre of Finland
Hospital District of Helsinki and Uusimaa
Tampere University
Buddy Healthcare Ltd
Information provided by (Responsible Party):
University of Oulu

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.

Condition or disease Intervention/treatment Phase
Tonsillitis Herniorrhaphies Surgery Children Parents Device: IcorySolution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
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
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 15, 2020

Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Arja Rantala +358504340424 arja.rantala@oulu.fi
Contact: Pekka Lahdenne +358504285521 pekka.lahdenne@hus.fi

Locations
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Finland
New Children´s Hospital
Helsinki, Finland
Sponsors and Collaborators
University of Oulu
VTT Technical Research Centre of Finland
Hospital District of Helsinki and Uusimaa
Tampere University
Buddy Healthcare Ltd
Investigators
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Principal Investigator: Pekka Lahdenne New Children´s Hospital

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

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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT04277299    
Other Study ID Numbers: HUS180/2020
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to GDPR in Finland, we doesn't plan to share data to public

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases