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| ID | Type | Description | Link |
|---|---|---|---|
| R44DA049640 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR googles using exposure sham program | Placebo Comparator | The study groups will receive VR googles and the sham program |
|
| VR googles and the real VR program experience. | Active Comparator | The study group will receive the VR googles and the real VR program experience. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo comparator: VR googles and the non reality experience | Device | parallel assignment (this arm will receive a static presentation in the same device) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the end of surgery until 48 hours after surgery or discharge, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | The investigators measured total opioid consumption converted to morphine milligram equivalents (MME). | End of surgery to 72 hours after surgery. |
| Time Weighted Average Pain Score |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabry Ayad, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37678233 | Derived | Araujo-Duran J, Kopac O, Montalvo Campana M, Bakal O, Sessler DI, Hofstra RL, Shah K, Turan A, Ayad S. Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial. Anesth Analg. 2024 Apr 1;138(4):751-759. doi: 10.1213/ANE.0000000000006642. Epub 2023 Sep 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality (VR) Headset With the Real VR Program Experience | The study group will receive the VR headset and the real VR program experience. |
| FG001 | VR Headset Using Sham 2D Programs | The study groups will receive VR headset and sham, two-dimensional programs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
113 patients were enrolled. 3 patients withdrew and requested to have their data excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Virtual Reality (VR) Headset With the Real VR Program Experience | The study group will receive the VR headset and the real VR program experience. |
| BG001 | VR Headset Using Sham 2D Programs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 113 patients were enrolled. 3 withdrew and requested to have their data excluded. 4 patients had missing data for the primary outcome. | Posted | Least Squares Mean | Standard Error | score on a scale | From the end of surgery until 48 hours after surgery or discharge, whichever comes first |
|
End of surgery up to 48 hours after surgery or discharge, whichever came first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality (VR) Headset With the Real VR Program Experience | The study group will receive the VR headset and the real VR program experience. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sabry Ayad | Cleveland Clinic | 216.476.7052 | Saayad@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2021 | Aug 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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)
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Single (Outcomes Assessor)
| Active Comparator: VR googles and the real VR program to enter act with and experience | Device | Parallel assignment (this arm will receive the full immersive virtual reality experience |
|
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.
| End of surgery to 48 hours after surgery |
| 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. | Once between last intervention time and hospital discharge (up to 8 days after end of surgery) |
| 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. | One week (7 days) after hospital discharge |
The study groups will receive VR headset and sham, two-dimensional programs
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | VR Headset Using Sham 2D Programs | The study groups will receive VR headset and sham, two-dimensional programs |
|
|
|
| Secondary | Total Opioid Consumption | The investigators measured total opioid consumption converted to morphine milligram equivalents (MME). | 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. And 3 other patients had missing data for this outcome. | Posted | Geometric Least Squares Mean | Standard Error | morphine milligrams equivalent | End of surgery to 72 hours after surgery. |
|
|
|
|
| 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. | 113 patients were enrolled. 3 patients withdrew and requested to have their data excluded. And 5 other patients had missing data for this outcome. | Posted | Least Squares Mean | Standard Error | units on a scale | End of surgery to 48 hours after surgery |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Once between last intervention time and hospital discharge (up to 8 days after end of surgery) |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | One week (7 days) after hospital discharge |
|
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | VR Headset Using Sham 2D Programs | The study groups will receive VR headset and sham, two-dimensional programs | 0 | 55 | 0 | 55 | 0 | 55 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |