Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

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: NCT03740607
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Annie Chow, Brooke Army Medical Center

Brief Summary:
Immersive virtual reality (iVR) has been used successfully to manage pain with distraction. It is a non-invasive treatment modality unassociated with worrisome well-known side effects typically seen when opioids and NSAIDS are used, and has previously been used safely in place of analgesia during dressing changes and burn care. This study investigates whether iVR can be useful as a stand-alone option to manage the pain associated with placement of peripheral intravenous (PIV) catheters in adults.

Condition or disease Intervention/treatment Phase
Procedural Anxiety Procedural Pain Perioperative Care Device: Virtual reality Procedure: Peripheral intravenous catheter placement Not Applicable

Detailed Description:
This is a prospective study of the effect of immersive virtual reality on the perception of pain during peripheral IV (PIV) placement. Adult patients who require PIV placement for elective surgery will be consented for intervention while in the peri-operative suites (PS). The VR intervention will consist of a headset and immersive VR software that allows the patient to engage in a virtual world during PIV placement. Subjects will be queried immediately after PIV placement using the validated graphic rating scale regarding the sensory, cognitive, and affective aspects of discomfort they experienced with PIV placement (Appendix A). They will also be asked two validated questions concerning patient satisfaction (Dexter et al 1997). A control group of patients will undergo a similar assessment with slightly different wording after receiving PIV placement without iVR.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: randomized prospective cohort
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 15, 2020

Arm Intervention/treatment
Experimental: Virtual reality during PIV placement
Randomized consented adult subjects will participate in a six-minute healthcare virtual reality software program via Samsung Gear virtual reality headsets while receiving 18 or 20-gauge peripheral intravenous catheter placement in peri-operative suite in preparation for surgery. They will be asked to rate their pain and discomfort afterwards using a graphic rating scale. They will be asked several questions about satisfaction, in order to elicit clinical significance of this intervention. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.
Device: Virtual reality
Healthcare virtual reality software implemented during peripheral intravenous catheter placement
Other Name: Samsung Gear Headset, AppliedVR software

Procedure: Peripheral intravenous catheter placement
Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.
Other Names:
  • IV
  • PIV

Placebo Comparator: Standard PIV placement
Adult control arm subjects will receive 18 or 20-gauge peripheral intravenous catheter placement according to current standard protocol, without virtual reality distraction .They will be asked to rate pain and discomfort afterwards using a graphic rating scale. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.
Procedure: Peripheral intravenous catheter placement
Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.
Other Names:
  • IV
  • PIV




Primary Outcome Measures :
  1. Discomfort associated with peripheral IV placement [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    Subject experiences will be measured using a validated graphic rating scale (GRS) which enquires about the extent to which the experience was unpleasant.


Secondary Outcome Measures :
  1. Magnitude of pain severity [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    Subjects will rate their worst pain during the IV placement on a scale of 1-10 out of 10 possible points

  2. Time spent thinking about pain [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    Subject will describe the amount of time spent thinking about pain during IV placement, as a proportion.

  3. Degree to which subject felt immersed in virtual reality [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    The subject will answer a question regarding the extent to which they felt they went "inside" the computer-generated world

  4. Nausea [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    Subject will answer a question regarding extent to which nausea was experienced during IV placement

  5. Claustrophobia [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    The subject will be asked to answer a question about the extent to which they felt claustrophobic for any reason during IV placement

  6. Clinical significance [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    the subject will be asked if they would want to have their IV placed this way again

  7. Satisfaction score [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    The subject will be asked if they were satisfied with IV placement

  8. Physiological parameters [ Time Frame: Initial vital signs at start of anesthesia care will be abstracted retrospectively. This reading will likely occur within an hour of the initial intervention, as start times for anesthesia cases are within an hour of initiation of peri-operative care ]
    Baseline vital signs- continuous variables

  9. Fun factor [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]
    Subject will describe the extent to which they found the experience to be fun, on a scale of 1-10



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:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Brooke Army Medical Center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation.

Exclusion Criteria:

Patients will be excluded with head wounds/head bandages preventing the use of a headset, active nausea/vomiting, history of seizure, dementia, psychosis, mania, vertigo, or motion sickness, if the patient is pregnant or incarcerated on the day of surgery, and if the patient is unable to consent self.


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): NCT03740607


Contacts
Layout table for location contacts
Contact: Annie L Chow, MD, MPH, MS 6093063329 chowanni@gmail.com
Contact: Cheng Yang, MD chengyang448@gmail.com

Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Layout table for investigator information
Study Director: Christopher Maani, MD BAMC Faculty

Publications:
Kenney MP, Milling LS. The effectiveness of virtual reality distraction for reducing pain: a meta-analysis. Psychology of Consciousness: Theory, Research, and Practice 3(3): 199-210, 2016.

Layout table for additonal information
Responsible Party: Annie Chow, Principal Investigator, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03740607     History of Changes
Other Study ID Numbers: c.2017.114d
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Annie Chow, Brooke Army Medical Center:
Adult
Peripheral IV
procedural pain
procedural anxiety
virtual reality
peripheral intravenous catheter

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