Effectiveness Study "HospiAvontuur":

NCT03671057 | Unknown

• 1 other identifier: PXL_hospi game
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative anxiety is frequently experienced by children undergoing anaesthesia and surgery and being separated from parents during the operation. It is associated with a significant number of adverse outcomes such as maladaptive behavioural changes and increased postoperative analgesic requirements. Pharmacological interventions such as midazolam are widely used to decrease preoperative anxiety in children. However, premedication may be associated with undesirable effects such as paradoxical reactions, prolonged sedation and adverse behavioural changes.The aim of this study is to develop and use a serious game, HospiAvontuur, which can be used during the preparation of children for an admission at the hospital. By using this game the researchers aim to reduce the usage of pharmacological interventions and to increase the use of non-pharmacological interventions, such as HospiAvontuur.

Conditions

Children; Preoperative Anxiety; Surgery

Keywords

serious game, preoperative anxiety reduction

Outcome Measures

Primary Outcomes (1)

• mYPAS-SF (pre-operative)

  For the measurement of the state anxiety, the mYPAS-SF (attachment 3) (modified Yale Preoperative Anxiety Scale - Short Version) will be used. In previous research projects usually the mYPAS (attachment 4) is used. The mYPAS was developed in 1995 (Kain et al, 1995) and modified in 1997 (Kain et al, 1997). It has been used in more than 100 studies spanning diverse health fields, such as anesthesia, surgery, paediatrics and dentistry (Cuzzocrea et al, 2013; Davidson et al, 2006; Huet et al, 2011; Weldon et al, 2004; Fortier et al, 2009; Fortier et al, 2010). This measurement instrument uses 5 items, each representing a different domain of child anxiety, and is used at 4 points in time during the preoperative phase. These 4 time points are: preoperative holding, walk to the OR, entrance to the OR (child enters the OR but has not yet seen the anesthesia mask), and introduction to the anesthesia mask (Jenkins et al, 2014).

  At baseline: at the beginning of the preoperative process

Secondary Outcomes (5)

• VAK 4-12 (Vragenlijst Angst Kinderen) for anxiety (pre-operative)

  Up to two weeks before baseline measurement: the VAK4-12 will be completed at home, before any intervention has taken place.

• ICC (pre-operative)

  At baseline: at the beginning of the preoperative process

• PAEDS (Pediatric Anxiety Emergency delirium Scale) (post-operative)

  Immediately after surgery

• OPS (Objective Pain Score) (Post-operative)

  Immediately after surgery

• Faces Pain Scale - Revised (FPS-R) (post-operative)

  After 2 days and after 1 week of surgery

Study Arms (2)

HospiAvontuur

EXPERIMENTAL

Intervention group - Non-pharmacological (HospiAvontuur) preparation HospiAvontuur is a simple point and click adventure game on a I-pad. The game describes the pathway which a child and his parents will take before, during and just after a hospital admission for an elective otorhinolaryngeal procedure under general anaesthesia.

Device: HospiAvontuur

Midazolam

ACTIVE COMPARATOR

control group: The children of the control group will not play the game HospiAvontuur as an at home preparation for surgery. These children will be prepared for surgery according to the current practice at the Jessa hospital. Children receive only the basic information during the consultation with the surgeon. There is no specific at home preparation required. When admitted at the hospital, children receive a pharmacological preparation, 45 - 60 minutes prior to the induction of the anaesthesia. The medication is administered orally by a small syringe in the mouth and contains Dormicum 0.3mg/kg body weight and atropine 0.02mg/kg body weight supplemented with raspberry syrup.

Drug: Midazolam

Interventions

HospiAvontuur DEVICE

To be included in the study children should play the game at least one time together with one parent

Also known as: Tablet application

HospiAvontuur

Midazolam DRUG

current practice in Jessa

Also known as: Anxiolytic

Midazolam

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children from 4 up to (and included) 7 years old. The children represent a large group within the otorhinolaryngeal discipline and these children are within the same cognitive phase when it comes to playing a serious game
• Children who need otorhinolaryngeal surgery for the first time.
• Children and at least one of the parents are able to comprehend and speak the Dutch language.
• Children who will receive a mask induction of the anaesthesia.

You may not qualify if:

• Older and younger children than the mentioned age group.
• Children who do not have a complete comprehension of the Dutch language. Children will not be excluded based on cultural or background information.
• Children who had previous surgical experiences both elective or urgent.
• The following children will also be excluded from participation: children with mental retardation, children that have had opioids or sedative during the past month, children with early birth, children with behavioural dysfunction and children with a delayed cognitive development.

Sponsors & Collaborators

• PXL University College: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa

Hasselt, 3500, Belgium

RECRUITING

MeSH Terms

Interventions

Midazolam; Anti-Anxiety Agents

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Annemie IF Spooren, PhD

  PXL University College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jo IF Vrancken, MSc

CONTACT

003211775020; jo.vrancken@pxl.be

Liesbeth De Gryse, MSc

CONTACT

003211775020; Liesbeth.degryse@pxl.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two sets of cartboard boxes will be prepared. The boxes are prepared and numbered by the study investigator (F.V.) (the unique randomized test number) and distributed amongst the consultation offices of the surgeons by the researchers. To blind both the researchers and the surgeons, the 2 sets of boxes will have the same weight. The weight of the ipad is simulated in the boxes of the control group by the use of a coloring book. This will prevent patient selection bias. After the consultation and when the parent and the child has agreed to participate, the surgeon hands over a box to the parent. The surgeon writes the box number, name of the child, date of birth and the phone number of the child in an excel sheet. This document will be used during data procession. The patients participating in the trial, the treating physicians, the surgeons dispensing the study boxes, the researchers assessing outcomes and the data-managers will be blinded for group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design of the study will be a single blinded randomized clinical trial. Children will be divided in 2 research groups: an intervention group (children who will play the game HospiAvontuur as a non-pharmacological at home preparation prior to the hospital admission. These children will not receive any pharmacological preparation - Midazolam - at the hospital) and a control group (children who do not play the game at home and do receive a pharmacological preparation - Midazolam - at the hospital). Participants will be randomly assigned to the intervention group or the control group using a computer-generated random allocation sequence, created by the study investigator (F.V.). Each patient will receive a unique randomized test number.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: September 14, 2018
• Study Start: October 1, 2017
• Primary Completion: May 30, 2019
• Study Completion: July 30, 2019
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

BE (1)