Clinical trial NCT03750578: Virtual Reality for Needle Procedures in the Pediatric Emergency Department
Official title: Distraction in the Emergency Using Virtual Reality for Intravenous Needs in Children to Improve Comfort (DEVINCI): A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Anxiety
Pain
Keywords: virtual reality
procedural pain
pediatric emergency department
procedural anxiety
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 62
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventions. When venipuncture (either for IV line insertion or diagnostic venipuncture) is prescribed by a physician, a topical anesthetic cream (Maxilene® 4 - Lidocaine 4%) will be proposed to the patient, as standard of care. Usual positioning will be used by the staff nurse.

A) Virtual reality: Patients in this group will be offered virtual reality distraction through the use of OR.

B) Control intervention (standard of care): Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.
Primary purpose: OTHER

Brief summary: Venipuncture is a frequently performed painful and anxiogenic procedure in the paediatric emergency department (PED). Topical anesthetic creams are used to reduce pain, but additional modalities can modulate the nociceptive experience and distress associated with venipuncture. Distraction can improve a patient's experience by mitigating their ability to focus on the painful sensory input. Through its immersive nature, virtual reality (VR) has the potential to distract patients from a 'real world' negative experience such as venipuncture. Given the potential for short- and long-term consequences of poorly controlled pain and distress in children, healthcare professionals must optimize patient comfort during medically required procedures. The aim of this pilot pragmatic RCT study is to determine the feasibility, acceptability and preliminary effect of a VR device (head-mounted Oculus Rift® (OR)) for pain and distress reduction associated with venipuncture in the PED.

Detailed description: INTRODUCTION Pain management of venipuncture in the Paediatric Emergency Department (PED)

Inadequate pain management in paediatrics is known to have significant short and long-term consequences, such as negative memories, and greater pain perception during future procedures. This can in turn lead to chronic healthcare avoidance, with potential implications for increased morbidity. Suboptimal comfort plan is still consistently reported in the literature Venipuncture is a frequently performed painful and anxiogenic procedure in the paediatric emergency department (PED). It is among the most important causes of pain in paediatric wards. This can be distressing for children, parents and healthcare workers (HCW). Indeed, venipuncture is the leading cause of pain among hospitalized children. Up to 51% of pre-adolescents reported high levels of distress associated with this procedure. Many children reported moderate to severe procedural pain during their hospitalization according to recent studies. Moreover, physiologic evidence of distress has been reported in caregivers as they witness ED-based venipuncture in their child. Improved pain and distress management during venipuncture can also significantly decrease distress in ED nurses performing the procedure. It is therefore imperative to minimize the pain and distress associated with venipuncture, especially in a stressful environment such as the PED. Therefore, multimodal approaches are proposed, with combined strategies such as the four essential components by Friedrichsdorf, which include the use of topical anaesthetics, sucrose in neonate, comfortable positioning and distraction.

Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a venipuncture, the use of a topical anaesthetic cream is recommended prior to needle procedures, with options including EMLA ®, amethocaine and lidocaine. These products have shown favourable results when the cream is applied prior to venipuncture and IV cannulation. In the department, this strategy was introduced in 2013 and is available through a collective order for nurses to use. The cream can be applied by a triage nurse suspecting that the child will require venipuncture, or by the physician whose management plan includes a needle puncture. Unfortunately, despite no real disadvantage to its application, this is a strategy often forgotten by the treating team. At the study institution, the investigators use Maxilene®. Its application is shorter than EMLA, only requiring a 30 minute wait, which is often less than the time lapse, in the study PED, between the prescription of a venipuncture and the actual intervention. Moreover, the anesthetic cream has been proven to improve procedure success on first attempt and to shorten procedure time, compared to placebo. Despite these advantages, this strategy remains scarcely used as mentioned above.

Physical intervention: Comfort Position Due to their developmental characteristics, it is often difficult for children to rationally understand the indication for venipuncture. Immobilization is therefore used in many instances - up to 74% of the time according to a previous report - for intravenous (IV) placement or blood procuration. However, child restrain should be avoided as much as possible. Despite the use of topical anesthetics, venipuncture remains a traumatic experience for many children who are restrained. For this reason, a sitting position is encouraged in the literature to increase the comfort of paediatric patients during venipuncture.

Psychological intervention: Distraction Given the significant distress associated with venipuncture despite improvement with the use of topical anesthetics and positioning, other psychological adjuncts to pain management are important components of pain and distress management related to needle procedures. Psychological interventions are recognized strategies for pain and distress management in this setting, given their simplicity, practicality, and at a relatively low cost. Side effects are usually absent to minimal. Distraction is one such modality, based on the gate control theory, which improves a patient's experience by mitigating their ability to focus on the painful sensory input. Modalities such as the hide and find games ''I spy'', video games, bubbles, cartoons, ''stress balls'', and other sensory modalities have been used as adjuncts to pain management during venipuncture in children. The choice of modality depends on the setting and on the child's developmental age. Effective distraction techniques focus on children empowerment through attention to their preferences, using either active (eg. electronic games, ''I spy'' games) or passive (eg. music, video on television or tablet) distraction. In the study department, distraction strategies have been improved in the recent years by the Equipe Analgésie Urgence (EAU) team creating giant hide and find games in the procedure rooms and introducing electronic tablets for use during procedures. Further, members of the study team also studied other interventions done to distract children during painful procedures.

Through its immersive nature, virtual reality (VR) has the potential to effectively distract patients from a ''real world'' negative experience such as venipuncture. It is hypothesized that VR produces analgesia through inter-cortical modulation, which may explain decreases in the pain matrix seen in functional magnetic resonance imaging of patients exposed to VR while experiencing painful procedures.

Virtual reality in the PED Immersive virtual reality has been documented in different settings, including burn units, hematology-oncology units, and orthopaedic procedural sedation. A recent randomized control trial (RCT) demonstrated a reduction of procedural pain and anxiety in patients 10-21 years old undergoing blood drawing at a phlebotomy outpatient clinic. In the care of burn patients, VR was shown to improve patient experience and clinical outcomes. To the investigators' knowledge there is no study on VR for procedural pain management in the PED.

A recent review of VR in paediatric patients describes it as "a promising new technology that offers unique opportunities to modulate the experience of pain''. Potential side effects are few and infrequent. These include visually induced motion sickness, a risk of collisions with the surrounding environment, and a potential for creating ''false memories'' in younger children. These potential side effects can be reduced by excluding younger children (\<7 years old) until more suitable technologies are developed for this age group and also by working on the code source of a video (when possible) to modulate speed, pop ups, and other animations to better control for cyber-sicknesses.

Of note, the use of VR in healthcare settings has become more accessible due to the development of more portable and affordable systems. In this study, the investigators will use the Oculus Rift® (OR), which was purchased and mass produced by Facebook, allowing access to the latest technology in VR at a relatively low cost. OR is a VR tool that provides a wide field of view (FOV), high resolution display, integrated 3D audio and motion detection. In addition, its highly immersive properties could help achieve more distraction compared to other VR techniques as a review has shown that the sense of presence influences the effectiveness of VR-based analgesia. Presence refers to a subjective psychological state of consciousness of being in the virtual world. Immersiveness refers to the physical environment that could be quantified by measuring the field of view or the peripheral vision in the VR goggles.

The aims of this pilot RCT study is to address key areas (research design, methods, outcome measures, sample size, etc.) prior to conducting a future definitive trial. The investigators will therefore determine the acceptability and feasibility of a VR distraction using the OR in children requiring venipuncture in PED. The investigators also plan to evaluate the feasibility of the design and research methodology.

Objectives:

1. To determine the feasibility and acceptability of VR distraction using the OR in children undergoing venipuncture (IV line insertion or diagnostic venipuncture) in the PED.
2. To examine the preliminary effect of VR compared to standard practice on children's pain and distress related to venipuncture in the PED. Baseline estimate of the primary outcome (pain) will also inform sample size calculation of the definitive trial.
3. To determine parents', children's, and healthcare workers' (HCW) satisfaction regarding the use of VR for pain and distress management associated with venipuncture in the PED.
4. To determine feasibility and acceptability of the research design and methods including: recruitment rate, randomization and allocation, outcome measures, delivery of the interventions, rates of questionnaire completion, appropriateness of the inclusion criteria, among others.

METHODS. Design. Pilot pragmatic randomized control study using a parallel design with two groups: a) experimental group (VR+standard practice of needle-related pain management) or control (standard practice of needle-related pain management) Setting. The research will be conducted in a single ED, in a tertiary care paediatric university-affiliated hospital (Université de Montréal), the CHU Sainte-Justine in Montreal from August 2018 to June 2019. Sainte-Justine ED census is more than 80 000 patient-year.

Sample. Children from 7 to 17 years old who require venipuncture (IV line placement or diagnostic venipuncture) as prescribed by an attending physician. Research nurses and research assistants from the "Programme Intégré d'Étudiants à l'Urgence Volontaires pour la Recherche en Enfance de Sainte-Justine (PIEUVRES)" will identify eligible families in the waiting room of the ED using the institutional computerized database (between 8 AM and 8PM). These research assistants will approach a convenience sample of participants during day or evening shifts in the ED. Once they have accepted to participate and provided informed parent's consent and child's assent, participating families will be enrolled in the study.

As this is a pilot study, no sample size calculation is required. The investigators will randomize patients to one of the two intervention groups according to a list of randomization generated by an independent biostatistician. The investigators aim to recruit a total of 60 participants (30 patients/group) who will be randomized among the two groups during the study period. The investigators consider that this number would be adequate to provide information regarding feasibility of the intervention and study process/measures. It is estimated that close to 15 venipunctures are performed in the study department on a daily basis. The investigators therefore expect to reach the sample size within 9 months of the study start.

Interventions. When venipuncture (either for IV line insertion or diagnostic venipuncture) is prescribed by a physician, a topical anesthetic cream (Maxilene® 4 - Lidocaine 4%) will be proposed to the patient, as standard of care. Usual positioning will be used by the staff nurse.

A) RV : Patients in this group will be offered virtual reality distraction through the use of OR. VR produces a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cyber-sickness symptoms such as nausea, vomiting, headache. The video game was developed by the study team with three levels of difficulty tailored to the children's developmental stages, and adapted to a hospital environment, allowing control over its components designed to maximize the feeling of immersion and minimize cyber-sickness symptoms. The game was approved by a team of healthcare professionals involved in paediatric care. The game, oculus goggles and computer will be available in the PED at the onset of the study. The oculus goggle will be adjusted to the head of each child randomized to this group before any procedure and a period of 3 minutes will be allotted prior to venipuncture. This will allow the child to get familiarized with the game and immersed in the virtual environment (See photos in Annex).

B) Control intervention (standard of care): Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse. Standard behavioural techniques to relax children will be employed.

Eligibility criteria: Inclusion Criteria:

• Prescription of a venipuncture (IV line placement or diagnostic venipuncture) by an attending physician

Exclusion Criteria:

* Unstable patient or urgent procedure required
* Cognitive impairment that would render interaction with the VR game and/or answer to the study questionaires unfeasable.
* Diagnosis of epilepsy or any other condition precluding use of VR technology.
* A parent is unavailable to provide consent for participation in the study.

Primary outcomes:
measure: Self-reported pain during the procedure: Verbal Numerical Rating Scale (VNRS)
timeFrame: This outcome will be measured within 2 minutes of the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used) by asking the child to rate their level of pain during the procedure.
Secondary outcomes:
measure: Evaluation of overall pain management during venipuncture, with respect to pain relief, side effects, physical recovery, and emotional recovery.
timeFrame: Measured within 5 minutes following the end procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)
measure: Hetero-evaluation (by research nurse) of procedure-related distress
timeFrame: Measured during the procedure (period between the start of physical restraint or needle/catheter insertion until needle/catheter removal from vein and end of physical restraint in patients where it was used)
measure: Baseline pain score: Verbal Numerical Rating Scale (VNRS)
timeFrame: Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)
measure: Auto-evaluation of post procedure-related distress
timeFrame: Measured within 5 minutes following the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)
measure: Auto-evaluation of baseline procedure-related distress
timeFrame: Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: St Justine Hospital
state: Quebec
Study officials:
affiliation: Emergency Department, UdM
name: Esli Osmanlliu, MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department, UdM
name: Evelyne D. Trottier, MD,FRCPC
role: STUDY_DIRECTOR
affiliation: CHU Sainte-Justine Research Centre
name: Sylvie Lemay, PhD
role: STUDY_DIRECTOR
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