Clinical trial NCT04277299: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillitis
Herniorrhaphies
Surgery
Children
Parents
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: VTT Technical Research Centre of Finland
name: Hospital District of Helsinki and Uusimaa
name: Tampere University
name: Buddy Healthcare Ltd
First posted: 2020-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: mYPAS
timeFrame: 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 outcomes:
measure: CPMAS
timeFrame: 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
measure: Children´s postoperative pain
timeFrame: 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
measure: STAI- Y
timeFrame: 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
measure: Parental satisfaction: VAS
timeFrame: 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
measure: GAMEFULQUEST
timeFrame: Gamefulquest will be assessed 1 week after the operation
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: New Children´s Hospital
Study officials:
affiliation: New Children´s Hospital
name: Pekka Lahdenne
role: PRINCIPAL_INVESTIGATOR
References:
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