Clinical trial NCT04666506: Relaxation-VR: Implementation of Virtual Reality for Children in Hospital
Official title: Relaxation-VR: Implementation of Virtual Reality for Children in Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Pain
Stress
Keywords: Virtual reality
VR
paediatric
distraction
pain
anxiety
relaxation
Lead sponsor: Thomas More University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: Algemeen Ziekenhuis Sint_Maarten
First posted: 2020-12-14
Enrollment: 53
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Tolerability: Do participants experience symptoms of simulator sickness? (Pediatric Simulator Sickness Questionnaire)
timeFrame: Immediately after the intervention.
measure: Feasibility as assessed by the paediatric participants
timeFrame: Immediately after the intervention
measure: Acceptability as assessed by the paediatric participants (Would you use it again? Would you recommend it to others?)
timeFrame: Immediately after the intervention
measure: Feasibility as assessed by a parent of the paediatric patient
timeFrame: Immediately after the intervention
measure: Acceptability as assessed by a parent of the paediatric patient
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Changes in anxiety levels from pre-to-post intervention session: Visual Analogue Scale (VAS)
timeFrame: Immediately before and after the intervention.
measure: Changes in pain levels from pre-to-post intervention session: Faces Pain Rating Scale-Revised (FPRS-R)
timeFrame: Immediately before and after the intervention.
measure: Changes in emotion (happiness and arousal/stress) levels from pre-to-post intervention session: Two items of the Self-Assessment Manikin (SAM)
timeFrame: Immediately before and after the intervention.
Other outcomes:
measure: Clinicians' assessment of usability: System Usability Scale (SUS)
timeFrame: Approximately after 16 weeks (After the last participant has finished the last session)
measure: Clinicians' satisfaction: Client Satisfaction Scale (CSQ-3)
timeFrame: Approximately after 16 weeks (After the last paediatric patient data is collected)
measure: Clinicians' attitude towards Relaxation-VR via Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire
timeFrame: Approximately after 16 weeks (After the last paediatric patient data is collected)
measure: Exploration of barriers and facilitators of using VR in a hospital setting
timeFrame: Approximately after 16 weeks (After the last paediatric patient data is collected)
Locations:
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
state: Antwerpen
city: Jette
country: Belgium
facility: UZ Brussel
state: Vlaams-Brabant
Study officials:
References: