Summary

Eligibility
for people ages 65 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Linda Park, PhD, NP, RN (ucsf)
Headshot of Linda Park
Linda Park

Description

Summary

This single-arm mixed methods study aims to determine potential differences in self-reported postoperative pain intensity levels, anxiety, and state of relaxation through immediate pre-post intervention evaluation among those aged 65 or older who receive immersive virtual reality during their hospitalization, up to three days following major elective surgery. In addition, the investigators will evaluate the feasibility and acceptability of virtual reality for use in this older adult population. This study will not evaluate the efficacy of VR.

The main questions this study seeks to answer are:

  1. What is the feasibility and acceptability of using immersive virtual reality to impact clinical outcomes such as pain, anxiety, and relaxation in older adults who have undergone major elective surgery?
  2. What is the older adult's user experience with virtual reality during hospitalization up to the three days following major elective surgery?

Official Title

Immersive Virtual Reality to Decrease Postoperative Pain in Older Adults Following Elective Major Surgery: A Feasibility and Acceptability Study

Details

Current treatment options for postoperative pain in older adults tend to be concentrated on opioid and opioid-sparing medications, which carry an increased risk of complications in older adults. One non-pharmacological intervention to manage acute pain that has recently emerged in the healthcare setting is virtual reality (VR).VR engages the user through various technological equipment with differing degrees of immersion and has demonstrated efficacy in decreasing acute pain in various clinical settings, such as burn wound care treatment and adult and pediatric medical procedures. However, there is a scarcity of research examining VR as an adjunct treatment in older adult populations. Therefore, this study aims to examine the acceptability and efficacy of VR as a possible adjunct to current postoperative pain management regimens in older surgical patients undergoing inpatient elective major operations.

The overarching hypotheses are: 1. Older adults who receive immersive VR will demonstrate immediate improvements in self-reported pain intensity, anxiety, and state of relaxation from pre-intervention levels, and 2. Older adults will consider their VR experience positive, effective, and practical in the inpatient postoperative period, with negligible side effects reported.

The VR intervention will consist of the use of the REAL System i-Series VR head-mounted display (HMD) with built-in audio purchased from Penumbra, Inc. The i-Series is a gazed-controlled and fully immersive VR headset preloaded with immersive environments that promote positive distraction and relaxation through interactive experiences. These VR experiences include mindful meditation, travel, various nature scenes, and game experiences. After written informed consent is obtained and baseline questionnaires have been completed, enrolled participants will be given the option to utilize the REAL i-series HMD during their postoperative inpatient stay on the medical-surgical unit, as early as the first day following surgery (postoperative day [POD 1] 1) up through POD 3, unless discharge occurs first. The VR intervention will be offered to all participants at least once (for a maximum use of up to twice daily) up to six times. Each VR session will last up to no longer than 30 minutes. The length of each session will be dependent on the participant's selection of the virtual environment. Pain, anxiety, state of relaxation, and side effects will be measured before and after each VR session using pre-post questionnaires (Numeric rating scale for pain and relaxation and the Spielberger State Anxiety Inventory for anxiety). After each VR session, participants will be asked about side effects. All participants will be asked to complete the System Usability Scale (SUS) questionnaire before discharge. Additionally, a convenience sample of up to 15 patients from diverse groups will be asked about their experience with VR through a one-time one-on-one, 15-minute qualitative semi-structured interview & a user satisfaction survey.

Keywords

Aged, Surgery, Pain, Postoperative, Virtual Reality, Postoperative Pain, REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc.

Eligibility

You can join if…

Open to people ages 65 years and up

  1. ≥ 65 years of age
  2. expected to be hospitalized for at least 48 hours after an elective major surgery
  3. able to speak, read, and understand English
  4. following surgery, is deemed stable and recovered by post-anesthesia care unit (PACU) and admitted to a medical-surgical unit by at least postoperative day 2

You CAN'T join if...

  1. patients with severe/profound cognitive impairments (i.e., SPMSQ score of four or less)
  2. patients with a history of self-reported motion sickness
  3. current or prior diagnosis of epilepsy
  4. injury or surgery to the eyes, face, or neck that prevents using a VR HMD
  5. non-elective surgery (urgent or emergency surgery)
  6. blindness or severe visual impairment
  7. severe hearing loss
  8. the VR system deemed inappropriate by the treating clinician
  9. patient reports nausea, vomiting, or dizziness just prior to the VR session

    10. acute illness preventing the use of the VR after surgery

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at University of California Health

  • Linda Park, PhD, NP, RN (ucsf)
    Dr. Park's program of research focuses on the secondary prevention of cardiovascular disease. Her current research projects center around determining the most engaging, practical, and meaningful technology-based interventions to improve patient self-care, clinical outcomes, and quality of life for patients with ischemic heart disease and heart failure.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06095661
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated