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

NCT ID: NCT06095661

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2024-06-01

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. 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?

Detailed Description

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.

Conditions

Aged; Surgery; Pain, Postoperative; Virtual Reality

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Park, PhD, NP, RN

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

23-39037

Identifier Type: -

Identifier Source: org_study_id