Virtual Reality for Needle Procedures in the Pediatric Emergency Department

NCT03750578 | Completed DMC

• 1 other identifier: 2019-2074
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Venipuncture is a frequently performed painful and anxiogenic procedure in the paediatric emergency department (PED). Topical anesthetic creams are used to reduce pain, but additional modalities can modulate the nociceptive experience and distress associated with venipuncture. Distraction can improve a patient's experience by mitigating their ability to focus on the painful sensory input. Through its immersive nature, virtual reality (VR) has the potential to distract patients from a 'real world' negative experience such as venipuncture. Given the potential for short- and long-term consequences of poorly controlled pain and distress in children, healthcare professionals must optimize patient comfort during medically required procedures. The aim of this pilot pragmatic RCT study is to determine the feasibility, acceptability and preliminary effect of a VR device (head-mounted Oculus Rift® (OR)) for pain and distress reduction associated with venipuncture in the PED.

Conditions

Procedural Anxiety; Pain

Keywords

virtual reality; procedural pain; pediatric emergency department; procedural anxiety

Outcome Measures

Primary Outcomes (1)

• Self-reported pain during the procedure: Verbal Numerical Rating Scale (VNRS)

  The primary outcome of this study is the mean pain score felt during the procedure (self-report of pain level during the procedure) measured by the Verbal Numerical Rating Scale (VNRS). The VNRS consists of pain scale from 0 (no pain) to 10 (extreme pain). It is a well-established, valid, and reliable tool for the self-report of pain intensity in children as young as 6 years of age. This scale is widely used as it requires a lower degree of abstraction and less resources when compared to the Visual Analog Scale (VAS). The VNRS requires no physical tools, which explains its wide use in older children and adults with acute pain.

  This outcome will be measured within 2 minutes of the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used) by asking the child to rate their level of pain during the procedure.

Secondary Outcomes (5)

• Evaluation of overall pain management during venipuncture, with respect to pain relief, side effects, physical recovery, and emotional recovery.

  Measured within 5 minutes following the end procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)

• Hetero-evaluation (by research nurse) of procedure-related distress

  Measured during the procedure (period between the start of physical restraint or needle/catheter insertion until needle/catheter removal from vein and end of physical restraint in patients where it was used)

• Baseline pain score: Verbal Numerical Rating Scale (VNRS)

  Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)

• Auto-evaluation of post procedure-related distress

  Measured within 5 minutes following the end of the procedure (removal of needle/catheter from vein and of physical restraint in patients where it was used)

• Auto-evaluation of baseline procedure-related distress

  Measured following recruitment and at most 10 minutes before the start of the procedure (before the start of physical restraint or needle/catheter insertion)

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Patients in this group will be offered virtual reality distraction through the use of OR in addition to standard of care.

Behavioral: Virtual Reality goggle (Oculus Rift ® Helmet)

Standard of care group

NO INTERVENTION

Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.

Interventions

Virtual Reality goggle (Oculus Rift ® Helmet) BEHAVIORAL

as described

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

• Prescription of a venipuncture (IV line placement or diagnostic venipuncture) by an attending physician

You may not qualify if:

• Unstable patient or urgent procedure required
• Cognitive impairment that would render interaction with the VR game and/or answer to the study questionaires unfeasable.
• Diagnosis of epilepsy or any other condition precluding use of VR technology.
• A parent is unavailable to provide consent for participation in the study.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

St Justine Hospital

Montreal, Quebec, H3T1C5, Canada

Location

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MeSH Terms

Conditions

Pain; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esli Osmanlliu, MD,FRCPC

  Emergency Department, UdM

  PRINCIPAL INVESTIGATOR

• Evelyne D. Trottier, MD,FRCPC

  Emergency Department, UdM

  STUDY DIRECTOR

• Sylvie Lemay, PhD

  CHU Sainte-Justine Research Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Pediatric Emergency Medicine

Model Details: Interventions. When venipuncture (either for IV line insertion or diagnostic venipuncture) is prescribed by a physician, a topical anesthetic cream (Maxilene® 4 - Lidocaine 4%) will be proposed to the patient, as standard of care. Usual positioning will be used by the staff nurse. A) Virtual reality: Patients in this group will be offered virtual reality distraction through the use of OR. B) Control intervention (standard of care): Patients in this group will receive standard care, including the proposition to use topical anesthetic cream prior to venipuncture attempt, usual distraction and positioning proposed by the treating nurse.

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: November 23, 2018
• Study Start: December 17, 2018
• Primary Completion: April 30, 2019
• Study Completion: June 1, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)