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

NCT04666506 | Completed DMC

• 1 other identifier: IC_PED_01
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety; Pain; Stress

Keywords

Virtual reality; VR; paediatric; distraction; pain; anxiety; relaxation

Outcome Measures

Primary Outcomes (5)

• Tolerability: Do participants experience symptoms of simulator sickness? (Pediatric Simulator Sickness Questionnaire)

  This questionnaire is based on the Simulator Sickness Questionnaire (SSQ) and is used to assess physical adverse events due to the VR intervention. The query language of the SSQ was simplified for children and modified Wong-Baker faces were added to create a Peds SSQ, with a score of 0 (happy face) indicating no adverse event and a score of 6 (unhappy face) indicating more severe adverse event. The Peds SSQ, in accordance with the SSQ, contains queries that probe four symptom categories: eye strain, head and neck discomfort, sleepiness or fatigue, and dizziness or nausea. A lower score indicates a better outcome.

  Immediately after the intervention.

• Feasibility as assessed by the paediatric participants

  Survey comprised of a combination of open-ended and response-set questions. Ease of use assessed with Visual Analogue Scale (VAS) ranging from 0 (very easy) to 100 (very difficult). Fun assessed with Visual Analogue Scale (VAS) ranging from 0 (A lot of fun to 100 (No fun at all).

  Immediately after the intervention

• Acceptability as assessed by the paediatric participants (Would you use it again? Would you recommend it to others?)

  Survey comprised of a combination of open-ended and response-set questions.

  Immediately after the intervention

• Feasibility as assessed by a parent of the paediatric patient

  Survey comprised of a combination of open-ended and response-set questions. E.g. Did the child keep the VR-headset on during the entire procedure?

  Immediately after the intervention

• Acceptability as assessed by a parent of the paediatric patient

  Survey comprised of a combination of open-ended and response-set questions. E.g., Why did you want to try it? Would you use it again?

  Immediately after the intervention

Secondary Outcomes (3)

• Changes in anxiety levels from pre-to-post intervention session: Visual Analogue Scale (VAS)

  Immediately before and after the intervention.

• Changes in pain levels from pre-to-post intervention session: Faces Pain Rating Scale-Revised (FPRS-R)

  Immediately before and after the intervention.

• Changes in emotion (happiness and arousal/stress) levels from pre-to-post intervention session: Two items of the Self-Assessment Manikin (SAM)

  Immediately before and after the intervention.

Other Outcomes (4)

• Clinicians' assessment of usability: System Usability Scale (SUS)

  Approximately after 16 weeks (After the last participant has finished the last session)

• Clinicians' satisfaction: Client Satisfaction Scale (CSQ-3)

  Approximately after 16 weeks (After the last paediatric patient data is collected)

• Clinicians' attitude towards Relaxation-VR via Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire

  Approximately after 16 weeks (After the last paediatric patient data is collected)

Study Arms (2)

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,...).

Other: Virtual reality

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,...).

Other: Virtual reality

Interventions

Virtual reality 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).

Also known as: Relaxation-VR

VR as distraction during a medical procedure; VR as relaxation method during a hospital stay

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient or outpatient in one of the study sites (UZ Brussel or AZ Sint-Maarten): each paediatric patient who will undergo a medical (nursing) procedure during the study period (1-01-2021 and 30-09-2021) and/or is in need of relaxation or distraction, as assessed by the clinical expertise of the involved clinical staff. Note that in this study no specific medical procedure, treatment or patient population is chosen to increase the ecological validity of the study.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas More University of Applied Sciences: lead
• Universitair Ziekenhuis Brussel: collaborator
• Algemeen Ziekenhuis Sint_Maarten: collaborator

Study Sites (2)

AZ Sint-Maarten

Mechelen, Antwerpen, 2800, Belgium

Location

UZ Brussel

Jette, Vlaams-Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 14, 2020
• Study Start: January 4, 2021
• Primary Completion: May 16, 2021
• Study Completion: May 16, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)