Using Virtual Reality to Reduce Procedural Pain in Children With Cancer

NCT02929771 | Completed DMC

• 1 other identifier: 1000053757
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the impact of virtual reality (VR) in decreasing procedural pain related to subcutaneous port (SCP) access in children with cancer. The study is a pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with detailed information on the feasibility of implementing our trial protocol in a future multi-center RCT as well as preliminary estimate of VR treatment effect on children with cancer undergoing SCP access, including child and parent factors potentially associated with VR distraction treatment efficacy.

Conditions

Cancer

Keywords

Virtual Reality; Subcutaneous Port Sampling; Pain; Children

Outcome Measures

Primary Outcomes (4)

• Accural Rates/Retention Rates

  Using a recruitment log to measure eligible children per recruitment day, reasons for ineligibility, reasons for non-participation and reasons for study attrition.

  6 months

• Acceptability

  Measured using the VR Distraction Satisfaction Questionnaire completed by children and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.

  6 months

• Outcome measure feasibility

  Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log

  6 months

• Technical Difficulties/Practical Difficulties

  Record data related to technical/practical difficulties associated with the VR intervention, RA observed difficulties in implementing the trial protocol in the clinic and time to complete SCP access.

  6 months

Secondary Outcomes (6)

• Pain Intensity

  6 months

• Child Distress

  6 months

• Child Fear

  6 months

• Child Pain Catastrophizing

  6 months

• Parent Pain Catastrophizing

  6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

In addition to usual care, the intervention group will receive the Samsung GearVR with head mounted display (HMD), controller, and headphones. They will situated in front of the nurse and beside/on the lap of the parent, or they may be lying supine. The VR intervention will use auditory and visual stimuli (simulating the peaceful underwater environment) to distract the child before, during, and after the SCP needle insertion. Children will be allowed to 'try-out' the VR system before the SCP access to familiarize themselves with the equipment. The entire study will be videotaped.

Device: Samsung GearVR

Control Group

ACTIVE COMPARATOR

In addition to usual care, participants in the control group will be seated with their parent and in front of the nurse, according to preference. Children will watch an age appropriate video selected by an oncology-affiliated child life specialist on an iPad, while wearing the same headphones used in the experimental condition. The RA will hold the iPad and positioned within a meter of the child so that the child can still see the iPad without the RA interfering in the clinical procedure. The entire study will be videotaped.

Device: iPad

Interventions

Samsung GearVR DEVICE

VR with head mounted display (HMD) and headphones. Treatment

Intervention Group

iPad DEVICE

iPad with headphones. Control

Control Group

Eligibility Criteria

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

You may qualify if:

• Child and parent able to speak and understand English
• actively undergoing cancer treatment
• being less than 1 year from initial diagnosis
• requiring at least 2 SCP needle insertions for cancer treatment over the following 8 weeks

You may not qualify if:

• visual, auditory or cognitive impairments precluding interaction with the intervention or control equipment
• patients with major co-morbid medical or psychiatric conditions (including needle-phobia\_ as per their healthcare provider or parent
• end of life patients
• patients with a MRSA infection or symptoms of respiratory or gastrointestinal infection as per any member of their healthcare team which could contaminate the intervention or control equipment
• participation in usability study

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer Stinson, RN, NP, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Clinical Nurse Specialist/NP, PhD

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 11, 2016
• Study Start: August 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)