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Virtual Reality as a Postoperative Pain Management Adjunct in Older Adults: An Acceptability and Feasibility Study

NCT06095661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-06-18

No results posted yet for this study

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?

Conditions

  • Aged
  • Surgery
  • Pain, Postoperative
  • Virtual Reality

Interventions

OTHER

REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc.

The VR intervention will use 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. REAL i-Series is classified as an unclassified product with product code PWC, a general wellness product FDA #3005168196.

Sponsors & Collaborators

Principal Investigators

  • Linda Park, PhD, NP, RN · University of California, San Francisco

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2024-02-28
Completion
2024-06-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095661 on ClinicalTrials.gov