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

NCT02947243 | Withdrawn

• 1 other identifier: 2017-1383
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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 ® 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. To the knowledge of the investigators, none of the pediatric hospitals across Canada have tested VR as a method of pain and anxiety management in children with burn injuries. Overall hypotheses: VR distraction via Oculus Rift ® could be an effective method to relieve pain, and anxiety, as well as a less traumatizing hospital experience, while promoting a more humanistic care environment by combining new technologies (VR via Oculus Rift ®) to standard analgesic interventions administered to these children. The expected results will have a direct effect on physical (pain) and psychological (anxiety, pain memories) health of the child. In addition, clinical implications may include other indicators of quality of care and economic benefits such as a wider range of motion of burned limbs and reduction in dosage of opioids and anxiolytic drugs administered.

Conditions

Pain; Burns; Child; Anxiety

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

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score

  Numerical Rating Scale (NRS) ranging from 0 to 10; 0=no pain to 10=pain as bad as it could be

  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)

Secondary Outcomes (9)

• Pain Experience

  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)

• Expected Anxiety

  Baseline (T1)

• Experienced Anxiety

  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)

• Satisfaction Level

  T4: 30 minutes after the procedure

• Side Effects

  T4: 30 minutes after the procedure

Study Arms (2)

Standard pharmacological treatment

ACTIVE COMPARATOR

Standard pharmacological treatment (including Morphine) according to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.

Drug: Morphine

VR distraction via Oculus Rift

EXPERIMENTAL

In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention.

Device: VR distraction via Oculus Rift

Interventions

VR distraction via Oculus Rift DEVICE

In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the burn site, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, will be adapted for children and tailored to minimize cyber sickness.

VR distraction via Oculus Rift

Morphine DRUG

As per unit's protocol

Also known as: Standard pharmacological treatment

Standard pharmacological treatment

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• requiring intensive care
• having a diagnosed cognitive impairment
• are unconscious or intubated during dressing change or physiotherapy
• suffer from epilepsy (considering the nature of the intervention)
• allergic to opioids or other analgesics used for standard pharmacological treatment
• having burn injuries on the face preventing the use of the Oculus Rift headset

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Ste. Justine

Montreal, Quebec, H3T 1C4, Canada

Location

MeSH Terms

Conditions

Pain; Burns; Anxiety Disorders; Pain, Procedural; Acute Pain; Agnosia; Deafness, Autosomal Recessive 1A

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 27, 2016
• Study Start: May 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

CA (1)