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Effectiveness Study "HospiAvontuur":

NCT03671057 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2018-11-20

No results posted yet for this study

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

Interventions

DEVICE

HospiAvontuur

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

DRUG

Midazolam

current practice in Jessa

Sponsors & Collaborators

  • Jessa Hospital

    collaborator OTHER

  • PXL University College

    lead OTHER

Principal Investigators

  • Annemie IF Spooren, PhD · PXL University College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2019-05-30
Completion
2019-07-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03671057 on ClinicalTrials.gov