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

Surgery Clinical Trial

— VR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095661
• Other study ID #: 23-39037
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: Christina Keny, PhD(c), RN
• Phone: 4086126143
• Email: christina.keny[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Pain, Postoperative
• Surgery
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	The 11-point numeric scale ranges from '0' representing "Not relaxed at all" to '10' representing " As relaxed as one could imagine." A change = relaxation score using NRS immediately after use of virtual reality - baseline NRS relaxation score taken immediately prior to use of virtual reality. Self-reported relaxation 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	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	Each item on the STAI-5 is scored on a scale of 1 to 4 with 1 representing " Not al all," 2 representing "somewhat," 3 representing "moderately so," and 4 representing "very much so." A higher score indicates a higher level of anxiety. A change = total STAI-5 score immediately after use of virtual reality - baseline STAI-5 score taken immediately prior to use of virtual reality. Self-reported anxiety scores using STAI-5 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	Detection of virtual reality side effects immediately after using virtual reality	A 5-item question survey with "yes" or "no" as response options, will be administered after each virtual reality session to determine participant self-reported side effects.	post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.
Secondary	Determine self-reported usability of virtual reality using the System Usability Scale(SUS).	The System Usability Scale(SUS) is reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents, with 1 representing "Strongly disagree" and 5 representing "Strongly agree". The participant's scores for each question are converted to a new number, added together, and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. A higher score indicates greater self-reported usability.	System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.
Secondary	Determine the overall user experience with virtual reality as an adjunct for postoperative pain 1-3 days after surgery during hospitalization.	Using 8 questions as part of a semi-structured interview guide, the overall user experience with virtual reality will be described through inductive qualitative thematic analysis. A one-time 15-minute recorded one-to-one interview will occur at study completion. Questions are focused on understanding the overall user experience.	System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.
Secondary	Determine user satisfaction with virtual reality using an 8-item survey.	Self-reported satisfaction scores (1 to 5; 1-totally disagree, 5-totally agree). A higher overall score indicates higher user satisfaction. The survey will be administered once at study completion prior to discharge.	User satisfaction with virtual realiuty will be measured at one timepoint- from post-surgery day 1 to day 3.
Secondary	Percentage of participants who complete all study questionnaires.	Compliance with questionnaire completion as measured by the proportion of recruited participants who use virtual reality at least once during the first 1-3 days post-surgery and complete all study questionnaires.	Completion of all study questionnaires will be measured at one time point- from study enrollment up until post-surgery 3 days.
Secondary	Percentage of older adults who declined to participate in the study.	Of the total number of older adults recruited for the study, the percentage of those declining to participate will be recorded, along with the reason(s) for non participation in the study.	Pre-intervention
Secondary	The percentage of virtual reality sessions started compared to the number of sessions offered.	Determine the overall percentage of virtual reality sessions completed compared to the number of sessions offered. Each participant will be offered a virtual reality session up to twice daily post-surgery day 1 to 3 for a total of 6 sessions.	Post-surgery day 1 to 3
Secondary	Duration of use for each virtual reality session	Determine the mean duration of use.	Post-surgery day 1 to 3
Secondary	Assessment of the ability to retain enrolled participants.	The proportion of enrolled participants who complete baseline questionnaires but do not start the first virtual reality session during 1-3 post-surgery.	from 1-day post-surgery up to approximately 3 days post-surgery during hospita
Secondary	Rate of discontinued interventions	Determine the number of enrolled participants who do not complete more than one virtual reality session and the reason for discontinuing study participation.	Post-surgery day 1 to 3