AgedVRNCT06095661
Virtual Reality as a Postoperative Pain Management Adjunct in Older Adults: An Acceptability and Feasibility Study
A study testing REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc. in people with Aged and Surgery, run by University of California, San Francisco at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged, Surgery, Pain, Postoperative
- What is being tested?
- REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Immersive Virtual Reality to Decrease Postoperative Pain in Older Adults Following Elective Major Surgery: A Feasibility and Acceptability Study
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:
- 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?
- What is the older adult's user experience with virtual reality during hospitalization up to the three days following major elective surgery?
Read the 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
- Being tested
- REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).
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.
Measured: 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.
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.
Measured: System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.
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.
Measured: User satisfaction with virtual realiuty will be measured at one timepoint- from post-surgery day 1 to day 3.
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.
Measured: Completion of all study questionnaires will be measured at one time point- from study enrollment up until post-surgery 3 days.
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.
Measured: Pre-intervention
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.
Measured: Post-surgery day 1 to 3
Duration of use for each virtual reality session
Determine the mean duration of use.
Measured: Post-surgery day 1 to 3
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.
Measured: from 1-day post-surgery up to approximately 3 days post-surgery during hospita
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.
Measured: Post-surgery day 1 to 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start26 Oct 2023
- Primary completion28 Feb 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Park, PhD, NP, RN, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095661
- Sponsor's protocol ID
- 23-39037
- Acronym
- VR
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality to Decrease Postoperative Pain in Older Adults Following Elective Major Surgery: A Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT06095661
- Acronym / sponsor ID
- VR / 23-39037
- Conditions
- Aged, Surgery, Pain, Postoperative, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc.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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Virtual Reality |
Primary outcome
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
Time frame: Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.
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.
12 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: System Usability will be measured at one timepoint- from post-surgery day 1 to day 3.
Determine user satisfaction with virtual reality using an 8-item survey.
Time frame: User satisfaction with virtual realiuty will be measured at one timepoint- from post-surgery day 1 to day 3.
Percentage of participants who complete all study questionnaires.
Time frame: Completion of all study questionnaires will be measured at one time point- from study enrollment up until post-surgery 3 days.
Percentage of older adults who declined to participate in the study.
Time frame: Pre-intervention
The percentage of virtual reality sessions started compared to the number of sessions offered.
Time frame: Post-surgery day 1 to 3
Duration of use for each virtual reality session
Time frame: Post-surgery day 1 to 3
Assessment of the ability to retain enrolled participants.
Time frame: from 1-day post-surgery up to approximately 3 days post-surgery during hospita
Rate of discontinued interventions
Time frame: Post-surgery day 1 to 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Park, PhD, NP, RN principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAL System i-Series VR head-mounted display (HMD) from Penumbra, Inc. in people with Aged and Surgery, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Pre/post virtual reality from 1-day post-surgery up to approximately 3 days post-surgery during hospitalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.