Postoperative Pain
Conditions
Brief summary
Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.
Detailed description
Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.
Interventions
DEVICEPlacebo comparator: VR googles and the non reality experience
parallel assignment (this arm will receive a static presentation in the same device)
DEVICEActive Comparator: VR googles and the real VR program to enter act with and experience
Parallel assignment (this arm will receive the full immersive virtual reality experience
Sponsors
National Institute on Drug Abuse (NIDA)
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Single (Outcomes Assessor)
Intervention model description
parallel assignment (one arm will receive the full immersive virtual reality experience and the other arm will receive a static presentation in the same device)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiology Physical Status 1-3; * Scheduled for elective, primary total hip arthroplasty; * Anticipated hospitalization of at least 1 night; * Expected to require parenteral opioids for postoperative pain; * Able to use IV PCA systems.
Exclusion criteria
* History of chronic pain or care by a pain management specialist; * Use of more than 30 mg/day of oral oxycodone (or equivalent); * Greater than 12 weeks of current and continued opioid use; * History of seizures, epilepsy, motion sickness, stroke, dementia; * Non-English speaking; * Women who are pregnant or breastfeeding; * History of substance use disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (Numerical Rating Scale) | From the end of surgery until 48 hours after surgery or discharge, whichever comes first | The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | End of surgery to 72 hours after surgery. | The investigators measured total opioid consumption converted to morphine milligram equivalents (MME). |
| Time Weighted Average Pain Score | End of surgery to 48 hours after surgery | Pain scores collected by nursing staff every 4 hours during the first 48 hours after surgery. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain). The reported value is the least squares mean calculated using a mixed model for repeated measures. |
| Perception of Video System Usability | Once between last intervention time and hospital discharge (up to 8 days after end of surgery) | Patient's perception of video system usability was assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use. |
| Post Discharge Analgesia. | One week (7 days) after hospital discharge | Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Virtual Reality (VR) Headset With the Real VR Program Experience The study group will receive the VR headset and the real VR program experience. | 55 |
| VR Headset Using Sham 2D Programs The study groups will receive VR headset and sham, two-dimensional programs | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Virtual Reality (VR) Headset With the Real VR Program Experience | VR Headset Using Sham 2D Programs | Total |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 10 | 63 years STANDARD_DEVIATION 9 | 64 years STANDARD_DEVIATION 9.8 |
| BMI | 31 kg/m^2 STANDARD_DEVIATION 6 | 32 kg/m^2 STANDARD_DEVIATION 7 | 31.5 kg/m^2 STANDARD_DEVIATION 6.3 |
| Race/Ethnicity, Customized Black | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Multiracial | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Unavailable/Declined | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 49 Participants | 49 Participants | 98 Participants |
| Sex: Female, Male Female | 29 Participants | 26 Participants | 55 Participants |
| Sex: Female, Male Male | 26 Participants | 29 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Pain Scores (Numerical Rating Scale)
The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures.
Time frame: From the end of surgery until 48 hours after surgery or discharge, whichever comes first
Population: 113 patients were enrolled. 3 withdrew and requested to have their data excluded. 4 patients had missing data for the primary outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) Headset With the Real VR Program Experience | Pain Scores (Numerical Rating Scale) | 3.4 score on a scale | Standard Error 0.3 |
| VR Headset Using Sham 2D Programs | Pain Scores (Numerical Rating Scale) | 3.5 score on a scale | Standard Error 0.2 |
p-value: 0.391Mixed Models Analysis
Secondary
Perception of Video System Usability
Patient's perception of video system usability was assessed using a validated questionnaire (System Usability Scale). The System Usability Scale is scored from 0 to 100 and higher scores are related with devices that are easier to use.
Time frame: Once between last intervention time and hospital discharge (up to 8 days after end of surgery)
Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. Five patients had missing data for this outcome due to being lost to follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Reality (VR) Headset With the Real VR Program Experience | Perception of Video System Usability | 75 score on a scale |
| VR Headset Using Sham 2D Programs | Perception of Video System Usability | 70 score on a scale |
p-value: 0.244Wilcoxon (Mann-Whitney)
Secondary
Post Discharge Analgesia.
Pain Outcomes Questionnaire Short Form, which evaluates five domains (pain, mobility, activities of daily living, vitality, negative affect and fear). The Pain Outcomes Questionnaire Short Form is scored from 0 to 190 and higher scores are related with worst pain outcomes.
Time frame: One week (7 days) after hospital discharge
Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. Nine patients had missing data for this outcome due to being lost to follow up.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Virtual Reality (VR) Headset With the Real VR Program Experience | Post Discharge Analgesia. | 67 score on a scale |
| VR Headset Using Sham 2D Programs | Post Discharge Analgesia. | 58 score on a scale |
p-value: 0.191Wilcoxon (Mann-Whitney)
Secondary
Time Weighted Average Pain Score
Pain scores collected by nursing staff every 4 hours during the first 48 hours after surgery. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain). The reported value is the least squares mean calculated using a mixed model for repeated measures.
Time frame: End of surgery to 48 hours after surgery
Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. And 5 other patients had missing data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) Headset With the Real VR Program Experience | Time Weighted Average Pain Score | 4.3 units on a scale | Standard Error 0.6 |
| VR Headset Using Sham 2D Programs | Time Weighted Average Pain Score | 4.4 units on a scale | Standard Error 0.6 |
p-value: 0.768Mixed Models Analysis
Secondary
Total Opioid Consumption
The investigators measured total opioid consumption converted to morphine milligram equivalents (MME).
Time frame: End of surgery to 72 hours after surgery.
Population: 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. And 3 other patients had missing data for this outcome.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality (VR) Headset With the Real VR Program Experience | Total Opioid Consumption | 6.8 morphine milligrams equivalent | Standard Error 3.4 |
| VR Headset Using Sham 2D Programs | Total Opioid Consumption | 5.7 morphine milligrams equivalent | Standard Error 2.6 |
p-value: 0.608Regression, Linear