Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Using Virtual Reality to Reduce Procedural Pain in Children With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02929771
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Stinson, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Cancer Device: Samsung GearVR Device: iPad Not Applicable

Detailed Description:
The study is a repeated-measures cross-over pilot RCT to examine the feasibility of the trial protocol for a study into the effectiveness of immersive VR in minimizing procedural pain and distress in children with cancer. The research objectives are to: (1) pilot implementing immersive virtual reality (VR) for effectiveness testing in a future RCT (measured as implementation outcomes); (2) determine treatment effect sizes (measured as preliminary effectiveness outcomes), between VR, programmed to distract children during an SCP needle insertion, and an active control intervention (i.e., watching a video with headphones); and (3) assess impact of child and parent factors potentially associated with VR treatment effectiveness. Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics). A convenience sample of 40 children and adolescents with cancer (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. In addition, each child will act as their own control. A washout period of 1 month will be used to control for any carry-over effect between conditions. In addition to usual care, children in the experimental condition will wear the VR headset plus headphones. In the control condition, children will watch a video (i.e., an age-appropriate video selected by an oncology-affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition. Implementation outcomes include accrual and retention rates, acceptability and technical difficulties. Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Virtual Reality to Reduce Procedural Pain in Children With Cancer: A Pilot Randomized Controlled Trial
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: Intervention Group
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
VR with head mounted display (HMD) and headphones. Treatment

Active Comparator: Control Group
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
iPad with headphones. Control




Primary Outcome Measures :
  1. Accural Rates/Retention Rates [ Time Frame: 6 months ]
    Using a recruitment log to measure eligible children per recruitment day, reasons for ineligibility, reasons for non-participation and reasons for study attrition.

  2. Acceptability [ Time Frame: 6 months ]
    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.

  3. Outcome measure feasibility [ Time Frame: 6 months ]
    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

  4. Technical Difficulties/Practical Difficulties [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: 6 months ]
    For both pre and post study procedures, children will self report their pain and parents, nurses and the RA will report children's pain using an 11 point NRS scale (0 being no pain at all and 10 being the most pain you can imagine this child or you having)

  2. Child Distress [ Time Frame: 6 months ]
    For both pre and post study procedures, distress during the SCP study will be measured using the observer-rated Behavioural Approach-Avoidance Scale (BAADS). 2 research team members will code video-recordings from all SCP needle insertion using the BAADS.

  3. Child Fear [ Time Frame: 6 months ]
    Children will report fear both prior to and following the procedure using the CFS which is a visual scale with established psychometrics in children as young as 5.

  4. Child Pain Catastrophizing [ Time Frame: 6 months ]
    Children will report baseline tendencies to catastrophize about pain using the PCS-C.

  5. Parent Pain Catastrophizing [ Time Frame: 6 months ]
    Parents will report baseline tendencies to catastrophize about their child's pain using the PCS-P which is a self-reporting measure of pain.

  6. Parent Distress [ Time Frame: 6 months ]
    Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929771


Contacts
Layout table for location contacts
Contact: Jennifer Stinson, RN, NP, PhD 416 813 7654 ext 304514 jennifer.stinson@sickkids.ca

Locations
Layout table for location information
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Jennifer N Stinson, RN,PhD,CPNP    416-813-7654 ext 304514    jennifer.stinson@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Layout table for investigator information
Principal Investigator: Jennifer Stinson, RN, NP, PhD The Hospital for Sick Children

Layout table for additonal information
Responsible Party: Jennifer Stinson, Clinician Scientist, Clinical Nurse Specialist/NP, PhD, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02929771     History of Changes
Other Study ID Numbers: 1000053757
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Stinson, The Hospital for Sick Children:
Virtual Reality
Subcutaneous Port Sampling
Pain
Children

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Procedural
Pain
Neurologic Manifestations
Signs and Symptoms