Immersive Virtual Reality to Reduce Procedural Pain During IV Insertion in Children in the Emergency Department

NCT03435367 | Completed

• 1 other identifier: 1000058799
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Venipuncture and intravenous (IV) access continue to be the most common causes of pain and distress among children in the pediatric emergency department. Virtual reality has been successful for reducing pain and fear in many clinical scenarios, including port access in oncology patients, anxiety disorders, phobias, burn and wound care and others. There is only one previous study examining virtual reality distraction to reduce procedural pain during IV insertion in pediatric patients and no previous studies examining this in the emergency department setting. In this study, the investigators will compare immersive virtual reality (an interactive underwater environment) to the current standard (tablet device/iPad playing a movie) for distraction to reduce procedural pain during IV insertion. The investigators hypothesize that the immersive quality of the virtual reality will reduce patient's pain scores, fear scores and tachycardia during and after the procedure, and have minimal effect on departmental flow and nursing satisfaction. If this feasibility pilot study yields positive results, the investigators plan to expand to a larger randomized control trial.

Conditions

IV Insertion in the Emergency Department

Outcome Measures

Primary Outcomes (7)

• Change in Pain Intensity

  Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their pain and parents, nurses and the researcher will report children's pain BOTH prior to and following the procedure.

  Baseline, 30 minutes after baseline

• Change in Child Distress

  Using an 11 point Numerical Rating Scale (NRS) (0 being no distress at all and 10 being the most distress you can imagine this child or you having) children will self-report their distress and parents, nurses and the researcher will report children's distress BOTH prior to and following the procedure

  Baseline, 30 minutes after baseline

• Change in Child Fear

  Children will report fear BOTH prior to and following the procedure using the Child Fear Scale (CFS) which is a 5-face visual scale that measures fear intensity and is validated in children as young as 5 years. It consists of a 1-question scale rating fear from 0 - 4, based on the faces provided. A higher number represents higher fear intensity.

  Baseline, 30 minutes after baseline

• Child Pain Catastrophizing

  Children will report baseline tendencies to catastrophize about pain using the Pain Catastrophizing Scale - Child (PCS-C). This is a self-report measure of children's tendency to catastrophize about pain validated in children 8-18 years of age. 6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher pain catastrophizing.

  Baseline

• Parent Pain Catastrophizing

  Parents will report baseline tendencies to catastrophize about their child's pain using the Pain Catastrophizing Scale - Parent (PCS-P), which is a self-report measure of parents' tendency to catastrophize about their child's pain validated in parents of children 8-18 years of age. 6-items responded to on an 11-point scale from 0 ("not at all") to 10 ("a lot"), with a higher number representing higher parental pain catastrophizing of their child's pain.

  Baseline

• Parent Distress

  Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire. This measure consists of 4-items responded to on an 11-point numeric rating scale from 0 ("not at all") to 10 ("extremely"). A higher number value represents higher distress levels.

  30 minutes after baseline measures are completed

• Child Presence Measure

  This child self-report measure assesses effectiveness of the immersive aspect of the VR toolkit/iPad using 12 questions, a choice of three answers ("no", "a little", and "a lot").

  30 minutes after baseline measures are completed

Secondary Outcomes (4)

• Recruitment log

  through study completion, an average of 1 year

• Acceptability

  30 minutes after baseline measures are completed

• Outcome measure feasibility

  through study completion, an average of 1 year

• Technical Difficulties Log

  through study completion, an average of 1 year

Study Arms (2)

Intervention Group (VR)

EXPERIMENTAL

The patient will be allowed to 'try-out' the VR system (including all auditory and visual features) for \~5 minutes prior to the start of the procedure. In addition to usual care, consisting of child-life presence and topical analgesics if ordered by the treating medical team, children in the experimental condition will wear the VR HMD plus headphones and hold the VR controller.

Device: Virtual Reality Program

Control Group (Standard Care - Video)

ACTIVE COMPARATOR

The patient will be allowed to watch an age-appropriate video on a tablet device. The patient will be offered to wear the same headphones as in the experimental condition. The patient will have the tablet and headphones for \~5 minutes prior to the start of the procedure. In addition, the patient will receive standard care consisting of a child life specialist and topical analgesics (if ordered by the treating medical team).

Device: iPad Tablet

Interventions

Virtual Reality Program DEVICE

VR with head mounted display (HMD) and headphones.

Intervention Group (VR)

iPad Tablet DEVICE

iPad with headphones

Control Group (Standard Care - Video)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 8-17 years
• able to speak and understand English
• parent/guardian present
• medically stable (CTAS 2, 3, 4 or 5; IV insertion +/-20 minutes will not impact the safety of the patient according to treating medical team)
• requires IV insertion

You may not qualify if:

• visual, auditory or cognitive impairments precluding interaction with the VR intervention or reporting pain and fear
• psychiatric conditions that could be exacerbated by the VR environment (i.e. hallucinations)
• skin, face or ear infections or injuries, which could contaminate the intervention equipment
• medically unstable (CTAS 1; patient requires immediate IV insertion)

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 19, 2018
• Study Start: February 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

CA (1)