Relaxation-VR: Implementation of Virtual Reality for Children in Hospital

NCT ID: NCT04666506

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2021-05-16

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 and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.

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 involves various distraction techniques, either passive (e.g., music, movies) or active (e.g., interactive toys, electronic games, storytelling by the nursing staff). However, these distraction techniques can often be time consuming for the already busy and even over-demanded nursing staff.

A combination of distraction, extinction learning, cognitive-behavioral principles, mindful meditation, stress reduction, gate-control theory, and the spotlight theory of attention is believed to be the mechanism behind VR's effectiveness in pain management. Accumulating evidence supports VR as a feasible and effective method to alleviate anxiety and pain for paediatric patients during lumbar punctures, intravenous injections, burn wound care and rehabilitation. In particular, a recent meta-analysis reported that the use of VR was significantly more effective in reducing pain (14 studies) and anxiety (7 studies) than care as usual (CAU), with large effect size. Moreover, for chest radiography, the use of VR has also significantly reduced procedure time, while increasing patient satisfaction. As such, adding the use of VR to standard pain and anxiety management methods might improve both effectiveness and efficiency of current practice.

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 and local trials are scarce. In order to improve translation from research to practice, the current study will focus on the feasibility, acceptability, tolerability and preliminary effectiveness of 'Relaxation-VR', a VR application aiming to reduce anxiety and pain for children admitted to hospital, as experienced by both patients and clinical staff. This study will take place at the paediatric wards of two hospitals interested in adopting this innovative technology for improving both patient care (e.g., anxiety and pain reduction) and staff workload (e.g., shorter procedure times), UZ Brussel and AZ Sint-Maarten.

Conditions

Anxiety; Pain; Stress

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

VR as distraction during a medical procedure

Paediatric outpatients undergoing a medical procedure, aged 4-16 years old in Belgian hospitals UZ Brussel and AZ Sint-Maarten, will use VR as a distraction method during a potentially painful or scary procedure (e.g., vaccination, wound care, venipuncture,...).

Virtual reality

Intervention Type: OTHER

The VR intervention, Relaxation-VR, is a VR application developed by Psylaris aiming to reduce anxiety/stress and pain by distracting the patient in a relaxing environment. Relaxation-VR will be administered via a commercially available VR headset (Oculus Go). The VR headset is a piece of equipment that a person wears over their eyes that allows them to experience images and sounds produced by a computer as if they were part of real life (Cambridge Dictionary, 2020). As such, the patient is immersed in a novel, calming and distracting environment where the he/she is asked to perform tasks that will help the patients to relax when distressed before and/or during a medical procedure or during their stay in hospital.

The Relaxation-VR application consists of three modules: two modules make use of relaxation principles (i.e. breathing exercises, meditation) and one module presents a scene with different interactive animations and objects (i.e. popping bubbles, playing fetch with a dog).

VR as relaxation method during a hospital stay

Paediatric inpatients, aged 4-16 years old in Belgian hospitals UZ Brussel and AZ Sint-Maarten, will use VR as a relaxation method during a potentially stressful hospital stay (e.g., patients with psychosomatic complaints, patients with eating disorders,...).

Virtual reality

Intervention Type: OTHER

The VR intervention, Relaxation-VR, is a VR application developed by Psylaris aiming to reduce anxiety/stress and pain by distracting the patient in a relaxing environment. Relaxation-VR will be administered via a commercially available VR headset (Oculus Go). The VR headset is a piece of equipment that a person wears over their eyes that allows them to experience images and sounds produced by a computer as if they were part of real life (Cambridge Dictionary, 2020). As such, the patient is immersed in a novel, calming and distracting environment where the he/she is asked to perform tasks that will help the patients to relax when distressed before and/or during a medical procedure or during their stay in hospital.

The Relaxation-VR application consists of three modules: two modules make use of relaxation principles (i.e. breathing exercises, meditation) and one module presents a scene with different interactive animations and objects (i.e. popping bubbles, playing fetch with a dog).

Interventions

Virtual reality

The VR intervention, Relaxation-VR, is a VR application developed by Psylaris aiming to reduce anxiety/stress and pain by distracting the patient in a relaxing environment. Relaxation-VR will be administered via a commercially available VR headset (Oculus Go). The VR headset is a piece of equipment that a person wears over their eyes that allows them to experience images and sounds produced by a computer as if they were part of real life (Cambridge Dictionary, 2020). As such, the patient is immersed in a novel, calming and distracting environment where the he/she is asked to perform tasks that will help the patients to relax when distressed before and/or during a medical procedure or during their stay in hospital.

The Relaxation-VR application consists of three modules: two modules make use of relaxation principles (i.e. breathing exercises, meditation) and one module presents a scene with different interactive animations and objects (i.e. popping bubbles, playing fetch with a dog).

Intervention Type: OTHER

Other Intervention Names

Relaxation-VR

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

Algemeen Ziekenhuis Sint_Maarten

UNKNOWN

Sponsor Role: collaborator

Thomas More University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Sint-Maarten

Mechelen, Antwerpen, Belgium

UZ Brussel

Jette, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

IC_PED_01

Identifier Type: -

Identifier Source: org_study_id