Clinical trial NCT06095661: Virtual Reality as a Postoperative Pain Management Adjunct in Older Adults: An Acceptability and Feasibility Study
Official title: Immersive Virtual Reality to Decrease Postoperative Pain in Older Adults Following Elective Major Surgery: A Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Surgery
Pain, Postoperative
Virtual Reality
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.
Secondary outcomes:
measure: 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
timeFrame: Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.
measure: 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
timeFrame: Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.
measure: Detection of virtual reality side effects immediately after using virtual reality
timeFrame: post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.
measure: Determine self-reported usability of virtual reality using the System Usability Scale(SUS).
timeFrame: System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.
measure: Determine the overall user experience with virtual reality as an adjunct for postoperative pain 1-3 days after surgery during hospitalization.
timeFrame: System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.
measure: Determine user satisfaction with virtual reality using an 8-item survey.
timeFrame: User satisfaction with virtual realiuty will be measured at one timepoint- from post-surgery day 1 to day 3.
measure: Percentage of participants who complete all study questionnaires.
timeFrame: Completion of all study questionnaires will be measured at one time point- from study enrollment up until post-surgery 3 days.
measure: Percentage of older adults who declined to participate in the study.
timeFrame: Pre-intervention
measure: The percentage of virtual reality sessions started compared to the number of sessions offered.
timeFrame: Post-surgery day 1 to 3
measure: Duration of use for each virtual reality session
timeFrame: Post-surgery day 1 to 3
measure: Assessment of the ability to retain enrolled participants.
timeFrame: from 1-day post-surgery up to approximately 3 days post-surgery during hospita
measure: Rate of discontinued interventions
timeFrame: Post-surgery day 1 to 3
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Linda Park, PhD, NP, RN
role: PRINCIPAL_INVESTIGATOR
References: