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

NCT06095661 | Completed

• 1 other identifier: 23-39037
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Mean change from self-reported baseline pain immediately before using virtual reality on the 11-point Numeric Rating Scale (NRS) to immediately after using virtual reality

  The NRS is a validated unidimensional measure of self-reported pain intensity in adults after surgery. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing extreme pain. A change = pain score immediately after use of virtual reality - baseline pain score taken immediately prior to use of virtual reality. Self-reported pain scores using the NRS will be measured pre/post each time virtual reality is used, starting as early as 1-day following surgery up to approximately 3 days after surgery.

  Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.

Secondary Outcomes (12)

• Mean change from self-reported baseline state of relaxation immediately before using virtual reality on the 11-point Numeric Rating Scale (NRS) to immediately after using virtual reality

  Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.

• Mean change from self-reported baseline anxiety immediately before using virtual reality on the Spielberger State-Trait Anxiety Inventory (STAI) 5-item (STAI-5) to immediately after using virtual reality

  Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.

• Detection of virtual reality side effects immediately after using virtual reality

  post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.

• Determine self-reported usability of virtual reality using the System Usability Scale(SUS).

  System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.

• Determine the overall user experience with virtual reality as an adjunct for postoperative pain 1-3 days after surgery during hospitalization.

  System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.

Study Arms (1)

Virtual Reality

EXPERIMENTAL

Each enrolled participant in a single arm will be offered a virtual reality headset with a menu of virtual reality environments and experiences such as nature scenes, mindful meditation, travel, and various games. Enrolled participants be offered the virtual reality as early as the first day after their inpatient surgery in their hospital room. Each virtual reality session will last 5-30 minutes, depending on the participant's selection of the virtual reality environment/experience. Participants will have the option to use the virtual reality as often as twice daily up through the third day after their surgery during their hospitalization, for a total of six sessions.

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

Interventions

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

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.

Virtual Reality

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 65 years of age
• expected to be hospitalized for at least 48 hours after an elective major surgery
• able to speak, read, and understand English
• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxymetholone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Linda Park, PhD, NP, RN

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: October 23, 2023
• Study Start: October 26, 2023
• Primary Completion: February 28, 2024
• Study Completion: June 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)