Status:
COMPLETED
Relaxation-VR: Implementation of Virtual Reality for Children in Hospital
Lead Sponsor:
Thomas More University of Applied Sciences
Collaborating Sponsors:
Universitair Ziekenhuis Brussel
Algemeen Ziekenhuis Sint_Maarten
Conditions:
Anxiety
Pain
Eligibility:
All Genders
4-16 years
Brief Summary
Although on an international level, accumulating evidence supports the feasibility and effectiveness of VR for pain and anxiety management, in Belgium, adoption of VR in clinical practice is limited a...
Detailed Description
Current pain and anxiety management for children in hospital includes pharmacological analgesia (e.g. opioid therapy) with potential negative side effects. In addition, a non-pharmacological approach ...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained
- Inpatient or outpatient in one of the study sites (UZ Brussel or AZ Sint-Maarten): each paediatric patient who will undergo treatment or a single medical (nursing) procedure during the study period (1-01-2021 and 30-09-2021) and is in need of relaxation or distraction, as assessed by the clinical expertise of the involved clinical staff\*.
- For example (but not limited to), for the relaxation module of the VR intervention, following paediatric patients can be recruited: paediatric patients awaiting surgery, paediatric patients post-surgery during their (brief) stay in the recovery unit, paediatric patients staying at the oncological department, paediatric patients with eating disorders in need of relaxation after having eaten, or paediatric patients experiencing psychosomatic complaints (e.g. stomach ache).
- For example, for the distraction module of the VR intervention, following paediatric patients can be recruited: paediatric patients undergoing a single medical (nursing procedure) such as (but not limited to) wound care, blood draw or vaccination.
- Age range of ≥ 4 and ≤ 16
- Normal or corrected-to-normal vision
- Normal or corrected-to-normal hearing
- Note that in this study no specific medical procedure, treatment or patient population is chosen to increase the ecological validity of the study. In a real-life situation, the clinical staff chooses appropriate care methods (e.g. means of distraction or medication) based on their clinical expertise (in addition to treatment and pain management protocols). Therefore, the overall feasibility, acceptability, tolerability and initial clinical effect of the VR application are explored for an 'as-broad-as-possible' population, in order to provide information on what works best for whom with respect to Relaxation-VR. This practice-oriented approach allows us to investigate the potential of a VR intervention for a larger population, which could have the largest impact for the paediatric population and the clinical staff.
Exclusion
- Patient has a history of seizure disorders (e.g. epilepsy)
- Physical impairment that preclude VR intervention (e.g. facial burns or wounds, contagious infectious disease, need for intensive care)
- Patient will undergo a medical procedure or treatment that is considered unsuitable in combination with the use of a VR headset, as assessed by the clinical staff (e.g., facial wound care)
- Non-Dutch native speaker: Both the paediatric patient and his/her caregiver must be able to provide informed consent and assent
- Previous enrolment in this study (during a previous hospital stay)
Key Trial Info
Start Date :
January 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04666506
Start Date
January 4 2021
End Date
May 16 2021
Last Update
June 2 2021
Active Locations (2)
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1
AZ Sint-Maarten
Mechelen, Antwerpen, Belgium, 2800
2
UZ Brussel
Jette, Vlaams-Brabant, Belgium, 1090