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

NCT02977923 | Completed

• 1 other identifier: 1383
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

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

Outcome Measures

Primary Outcomes (1)

• Acceptability

  To assess the acceptability including the satisfaction of healthcare professionals regarding the use of the VR distraction via Oculus Rift during the treatment session. Pre-tested tailored questionnaire including satisfaction and acceptability outcomes (tolerance, positive and negative aspects, secondary effects).

  T4, immediately after the procedure completion, before leaving the procedure room

Secondary Outcomes (8)

• Mean Pain Score

  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

• 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)

• Comfort Level

  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)

Study Arms (2)

Standard pharmacological treatment

ACTIVE COMPARATOR

According to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.

Other: Standard pharmacological treatment

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. 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 site of the injury, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, were adapted for children and tailored to minimize cyber sickness.

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 site of the injury, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, were adapted for children and tailored to minimize cyber sickness.

VR distraction via Oculus Rift

Standard pharmacological treatment OTHER

according to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.

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 or another 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 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Quebec Nursing Intervention Research Network: collaborator

Study Sites (1)

CHU Ste. Justine

Montreal, Quebec, H3T 1C4, Canada

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Sylvie Le May, RN, 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: RN, PhD

Study Record Dates

• First Submitted: November 26, 2016
• First Posted: November 30, 2016
• Study Start: July 10, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)