Clinical trial NCT02977923: Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study
Official title: Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Burns
Child
Injuries
Keywords: Virtual reality
Immersive distraction
Oculus rift
Virtual world
Virtual environment
Procedural pain
Procedural anxiety
Acute pain
Pain management
Anxiety
Children, Child
Kid, Kids
Pediatric, Pediatrics
Young children
Burns
Burn injuries
Burn unit
Physiotherapy
Physical therapy
Burn dressing
Dressing change
Non-pharmacological, nonpharmacological
Clinical Research
Nursing Practice
Trauma
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Quebec Nursing Intervention Research Network
First posted: 2016-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children with injuries, including burns, experience severe pain intensity during medical procedures despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Virtual reality (VR) has gained growing consideration as a non-pharmacological method as it engages multiple senses and allows interactions with a virtual world. Oculus Rift ® (OR) is a new technology in VR that provides more immersiveness, at a relatively low cost, and could probably improve the management of pain and anxiety in wound care.

Overall hypothesis: Distraction by VR via the OR, in combination with the standard pharmacological treatment, is a feasible, acceptable and satisfactory method for the management of pain and anxiety during wound-related treatments in children with injuries.

Note that this pilot study will precede a larger trial aimed at assessing the effect of virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)

Detailed description: BACKGROUND:

Injuries, including burns, are the leading cause of morbidity and mortality in children. They are associated with a lot of pain that is difficult to treat and can impede recovery, cause high levels of anxiety and alter future pain behaviors, resulting, at times, in chronic pain, paresthesia, or depression. Pain can also decrease participation in treatments such as physiotherapy resulting in poor health outcomes. Beyond the immediate pain experience, children may also develop pain memory circuits. Procedural pain is still largely managed pharmacologically mostly through the use of opioids, benzodiazepines, and other pharmacological agents which cause a lot of side effects and do not always provide sufficient pain reduction. In recent years, the effectiveness of multimodal approaches combining medication with non-pharmacological interventions for procedural pain relief has been highlighte. Distraction techniques engaging multiple senses may grab the child's attention more than the techniques that only engage one sense (e.g, music), hence, the increasing interest in more immersive and interactive methods of distraction such as Virtual Reality (VR).

VR is an active distraction method that allows the user to interact with an immersive environment generated by a computer stimulating different senses. A review of studies on VR, mostly conducted with adult burn patients, showed a 35 to 50% reduction in procedural pain while using VR. However, despite promising results, the use of VR in healthcare settings has been limited, mainly due to its high cost. Reviews have highlighted the need for more research but mostly for the development of more portable, less expensive and more developed VR systems that would promote pain reduction during burn procedures especially for children with burn injuries who are considered one of the most challenging burn populations. However, there has been a breakthrough in technology since 2014 when big scale companies started investing in VR development for commercial gaming. Facebook purchased the Oculus Rift (OR) for mass production 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, it's highly immersive properties could help achieve more analgesia compared to other VR techniques as a review has shown that the sense of presence influences the effectiveness of VR-based analgesia. The sense of presence is a subjective psychological state of consciousness of being in the virtual world whereas 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 availability of inexpensive yet highly immersive VR goggles such as OR could increase the use of VR in pain management and burn settings while significantly improving its cost-effectiveness. A single case study assessed the feasibility of a VR intervention via OR in one child of 11 years old with burn injuries during occupational therapy. The study showed a reduction in pain intensity and pain unpleasantness experienced by the patient, without any side effects. To our knowledge, no other studies have tested the feasibility of OR for procedural pain management in children with injuries undergoing painful physiotherapy treatments or wound care.

AIM: The aim of this pilot clinical trial is to assess the acceptability and feasibility of VR distraction using the OR in children with injuries undergoing wound-related treatments (physiotherapy or dressing change). We also plan to evaluate the feasibility of the design and to predict appropriate sample size for a larger-scale clinical trial.

METHODS:

Design: Within-subject/crossover study design. Each child will serve as his own control and will receive both standard and experimental treatment during the same treatment session through a randomized order.

Sample and Setting: Convenience sampling on the surgical-trauma unit at CHU Ste-Justine, of children presenting with an injury.

Interventions. A) Standard pharmacological treatment as per the unit's protocol. B) VR distraction through the use of OR.The video games were developed by our team with a personalized care content tailored to the children's developmental stage and to maximize the feeling of immersion and minimize cybersickness, and approved by a team of healthcare professionals in pediatric care.

Study proceedings: Physiotherapy sessions and dressing changes typically last between 20 to 30 minutes. The duration will be divided into two sequences of the same duration (10 to 15 minutes) where the participant receives the same care by the same healthcare professional. For one sequence, only the standard treatment will be administered and for the other sequence, patients will receive the standard treatment in addition to VR via OR in a randomized order.

Measures: Pain and anxiety measures will be taken before the treatment session at (T1), after the first sequence of the session (T2) and after the second sequence of the session (T3) followed by a measure of nurses' satisfaction level via a questionnaire developed and pretested by the team. We will collect data on the average doses of analgesics administered before and during the session, and the side effects experienced in addition to the design's feasibility outcomes: participants recruited each month, adherence to study protocol.

Data analysis: Quantitative analysis. Mean differences in pain scores between sequences will be compared using Wilcoxon test.

Eligibility criteria: Inclusion Criteria:

* suffer from a burn or another injury requiring wound dressing change or physiotherapy
* presence of a consenting parent who can understand, read and write either French or English

Exclusion Criteria:

* Requiring intensive care
* Having a diagnosed cognitive impairment
* Are unconscious or intubated during dressing change or physiotherapy sessions
* Suffering from epilepsy (considering the nature of the intervention)
* Allergic to opioids or other analgesics used for standard pharmacological treatment
* Having injuries on the face preventing the use of the Oculus Rift helmet

Primary outcomes:
measure: Acceptability
timeFrame: T4, immediately after the procedure completion, before leaving the procedure room
Secondary outcomes:
measure: Mean Pain Score
timeFrame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session
measure: Pain Experience
timeFrame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
measure: Expected Anxiety
timeFrame: Baseline (T1)
measure: Experienced Anxiety
timeFrame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
measure: Comfort Level
timeFrame: T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
measure: Pain Memory
timeFrame: 24 hours after the procedure (T5)
measure: Anxiety Memory
timeFrame: 24 hours after the procedure (T5)
measure: Range Of Motion
timeFrame: Baseline (T1); T2: 10 minutes within the session (immediately after the first sequence of the session); T3: 20 minutes within the session (immediately after the second sequence of the session)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Ste. Justine
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Sylvie Le May, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: