Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study

2016-12-01 16:08:22 | BioPortfolio


Children with burn injuries 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 burn care. It also has the potential, with appropriate custom software designed for burn pediatric patients, to reduce the cybersickness symptoms (nausea, dizziness) associated with VR. 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 burn-related treatments in children with burn 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)



Burn injuries 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 burn injuries undergoing painful physiotherapy treatments.

AIM: The aim of this pilot clinical trial is to assess the acceptability and feasibility of VR distraction using the OR in children with burn injuries undergoing burn-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.


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 burn unit at CHU Ste-Justine, of children admitted for a burn 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 burn 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment




VR distraction via Oculus Rift, Standard pharmacological treatment


CHU Ste. Justine
H3T 1C4


Not yet recruiting


St. Justine's Hospital

Results (where available)

View Results


Published on BioPortfolio: 2016-12-01T16:08:22-0500

Clinical Trials [1683 Associated Clinical Trials listed on BioPortfolio]

Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population

Children with burn injuries experience severe pain intensity during medical procedures despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain managemen...

Virtual Reality Distraction for Procedural Pain Management and Anxiety in Children With Burn Injuries : A Pilot Study

Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several si...

Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial

Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several si...

Tablet Distraction for Pain Control During Venipuncture

Venipuncture is one of the painful procedures most frequently performed in children. Pain and distress management in children, during needle related procedures, is warranted. The base for...

Robot-Based Distraction to Reduce Pain and Distress in the Pediatric Emergency Department

Intravenous (IV) insertion is one of the most common procedures for children seeking medical treatment in the Emergency Department (ED). This procedure is often painful and distressing for...

PubMed Articles [24742 Associated PubMed Articles listed on BioPortfolio]

Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It?

Virtual reality (VR) is an exciting new technology with almost endless possible uses in medicine. One area it has shown promise is pain management. This selective review focused on studies that gave e...

Technical feasibility of personalized articulating knee joint distraction for treatment of tibiofemoral osteoarthritis.

Knee osteoarthritis is a highly prevalent degenerative joint disorder characterized by joint tissue damage and pain. Knee joint distraction has been introduced as a joint preserving surgical procedure...

Use of non-pharmacological strategies for pain relief in addiction treatment patients with chronic pain.

We examined use of non-pharmacological treatments for pain in addiction treatment patients.

Is non-pharmacological treatment an effective option for chronic low back pain?

Despite of pain being important warning signal for body ability to respond to internal or external threats, chronic pain is perceived as a discomfort by patients, leading to somatic, emotional and soc...

Too little, too much, or just right? Does the amount of distraction make a difference during contamination-related exposure?

The extant literature has shown mixed results regarding the impact of distraction use on exposure outcome; however, a wide variety of distraction tasks have been utilized across studies. In order to b...

Medical and Biotech [MESH] Definitions

Bone lengthening by gradual mechanical distraction. An external fixation device produces the distraction across the bone plate. The technique was originally applied to long bones but in recent years the method has been adapted for use with mandibular implants in maxillofacial surgery.

A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.

Persistent pain that is refractory to some or all forms of treatment.

An acute infection caused by the RIFT VALLEY FEVER VIRUS, an RNA arthropod-borne virus, affecting domestic animals and humans. In animals, symptoms include HEPATITIS; abortion (ABORTION, VETERINARY); and DEATH. In humans, symptoms range from those of a flu-like disease to hemorrhagic fever, ENCEPHALITIS, or BLINDNESS.

An alkaloid found in opium but not closely related to the other opium alkaloids in its structure or pharmacological actions. It is a direct-acting smooth muscle relaxant used in the treatment of impotence and as a vasodilator, especially for cerebral vasodilation. The mechanism of its pharmacological actions is not clear, but it apparently can inhibit phosphodiesterases and it may have direct actions on calcium channels.

More From BioPortfolio on "Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study"

Quick Search

Relevant Topics

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Pain Disorder
Pain is a feeling (sharp or dull) triggered in the nervous system which can be transient or constant. Pain can be specific to one area of the body eg back, abdomen or chest or more general all over the body eg muscles ache from the flu. Without pain ...

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Searches Linking to this Trial