Clinical trial NCT04291404: Virtual Reality-based Distraction to Reduce Distress in the Pediatric Emergency Department
Official title: A Randomized Controlled Trial of Virtual Reality-based Distraction for Venipuncture-related Distress in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children Requiring IV Placement
Keywords: Pain
Distress
Virtual Reality
Distraction Therapy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Needle procedures, such as intravenous (IV) insertions, are among the most commonly performed procedures for children needing medical care. IV insertions are often a painful and stressful experience for both children and their parents/ caregivers. Pediatric pain and distress that is not adequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for the family and clinical team.

Distraction therapy is a common psychological strategy which involves engaging children in a cognitive task or activity in order to divert attention away from painful stimuli. Given children's growing enthusiasm for novel technology, the investigators propose that an immersive virtual reality (VR) experience may provide an effective means of distraction for children undergoing IV insertions.

Detailed description: Objectives: The investigators' primary objective is to compare the reduction of distress with the use of distraction (via the VR intervention) versus current standard of care in children aged 6 to 17 years who are undergoing IV placement. The secondary objectives are to compare (a) the reduction of pain; (b) the reduction of fear; (c) the reduction of parental/caregiver anxiety; and (d) parental/caregiver and nurse satisfaction with the procedure in the intervention versus control arms; and (e) to assess the safety of using VR intervention in children aged 6 to17 years who are undergoing IV placement.

Research Plan: The investigators will conduct a randomized controlled trial consisting of a control arm receiving departmental standard of care and an intervention arm which will include the addition of an immersive VR experience to current standard of care. Children 6 to 17 years of age who are undergoing IV insertions in the Stollery Children's Hospital emergency department will be considered for enrollment into the study. Approximately 80 families will be recruited over a one-year period.

Study Intervention and Comparison: The VR intervention will aim to provide distraction by immersing the child in an artificial 3-dimensional environment that will engage them for the duration of the IV procedure. The child will wear a head-mounted display ("VR goggles") that will allow them to explore the virtual world through their own visual perspective in 360-degrees. A small handheld controller (optional) can be used to interact with the virtual environment and change settings. The VR goggles will occlude the patient's view of the treatment room, and a pair of noise-cancelling headphones (optional) can be used to further block out ambient hospital sounds. Together, this will provide the child with a unique vivid experience of being fully immersed or "present" inside the 3D virtual world. The control group will receive departmental standard of care which will include topical anesthetic cream (mandatory) and may include parent/caregiver support, child life services, nursing support, etc (at the discretion of the ED clinical care team and the family). At present, there is no single established distraction therapy or routine that is consistently employed for IV procedures within the study site ED. Thus, for pragmatic and ethical considerations, it is felt that the new study VR intervention should be compared to what is currently already in practice (ie. standard of care). Of note, other forms of technology (e.g. smart phones, tablets) will not be prohibited in the control group, if the family chooses to offer them. Due to ethical and pragmatic considerations, children in both groups must receive topical anesthetic cream for IV placement, as it is known to be effective and considered standard of care within the study hospital.

Study Impact: The use of immersive VR technology has previously shown promise in numerous healthcare settings. However, there is still a need for robust evidence regarding its effectiveness in treating pediatric distress associated with IV procedures, particularly in the emergency department. Results of this randomized controlled trial could inform an evidence-based strategy for the management of pediatric distress, which could be used in settings with and without child life specialists.

Eligibility criteria: We will include children presenting to the Stollery Children's Hospital ED, based on the eligibility criteria outlined below:

Inclusion Criteria:

1. child aged 6-17 years
2. requires IV placement
3. will receive topical anesthetic cream for IV placement

Exclusion Criteria:

1. medically unstable (CTAS 1, requires immediate IV insertion)
2. unconscious or not fully alert
3. visual, auditory or cognitive or mental health issues precluding safe interaction with the VR intervention
4. conditions that could be exacerbated by the VR environment (as reported by the family), such as: (i) current symptomatic nausea / vomiting / dizziness / migraine; (ii) history of psychosis / hallucinations / epilepsy
5. presence of an infection / injury which could contaminate the VR intervention equipment (as determined by the healthcare team) including but not limited to: (i) open wounds / infections of the head and neck area; (ii) suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) colonization
6. screens positive for 'influenza-like illness' (ILI) as per the current SCH ED screening criteria
7. child or parental language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator
8. previous enrollment in this study

Primary outcomes:
measure: Child's total distress score during the IV procedure
timeFrame: During the IV placement procedure
Secondary outcomes:
measure: Child's pain score during the IV procedure
timeFrame: Immediately after IV placement
measure: Child's Fear
timeFrame: Immediately after IV placement
measure: Parental anxiety
timeFrame: Immediately after IV placement
measure: Parent/ Caregiver Satisfaction
timeFrame: Immediately following the IV procedure
measure: Nurse Satisfaction
timeFrame: Immediately following the IV procedure
measure: Child Satisfaction
timeFrame: Immediately following the IV procedure
measure: Frequency of adverse events related to the study intervention
timeFrame: During the IV procedure
measure: Child's distress during the IV procedure
timeFrame: Immediately after IV placement
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Samina Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ali S, Rajagopal M, Stinson J, Ma K, Vandermeer B, Felkar B, Schreiner K, Proctor A, Plume J, Hartling L. Virtual reality-based distraction for intravenous insertion-related distress in children: a study protocol for a randomised controlled trial. BMJ Open. 2022 Mar 30;12(3):e057892. doi: 10.1136/bmjopen-2021-057892.