Recruiting

Virtual Reality

Sponsor:

Brooke Army Medical Center

Code:

NCT03740607

Conditions

Procedural Anxiety

Procedural Pain

Perioperative Care

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Virtual reality

Peripheral intravenous catheter placement

Study Details

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.

Conditions

Procedural Anxiety

Procedural Pain

Perioperative Care

Study ID

NCT03740607

Start date

Mar 1, 2019

Status verified date

Aug, 2021

Completion date

Sep 15, 2022

Anticipated

Primary completion date

Sep 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Virtual reality

Healthcare virtual reality software implemented during peripheral intravenous catheter placement

Peripheral intravenous catheter placement

Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.

Primary outcome measure

  • Discomfort associated with peripheral IV placement [ Time Frame: This outcome will be measured immediately after peripheral IV placement ]

Central Contacts and Locations

Central contacts

Annie L Chow, MD, MPH, MS

6093063329chowanni@gmail.com

Cheng Yang, MD

chengyang448@gmail.com

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Annie Chow, MD

210-228-6877annie.l.chow.mil@mail.mil

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Aug 26, 2021

Last verified

Aug, 2021

Keywords

  • Adult
  • Peripheral IV
  • procedural pain
  • procedural anxiety
  • virtual reality
  • peripheral intravenous catheter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2021-08-26.