Postoperative PainNCT04416555
Virtual Reality Distraction for Reduction
A study testing Active Comparator: VR googles and the real VR program to enter act with and experience in people with Postoperative Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Active Comparator: VR googles and the real VR program to enter act with and experience
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 3 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
About this study
Official title: Virtual Reality Distraction for Reduction in Acute Postoperative Pain
Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Placebo comparator: VR googles and the non reality experience, Active Comparator: VR googles and the real VR program to enter act with and experience
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo comparator: VR googles and the non reality experienceDevice
parallel assignment (this arm will receive a static presentation in the same device)
Active Comparator: VR googles and the real VR program to enter act with and experienceDevice
Parallel assignment (this arm will receive the full immersive virtual reality experience
| Study group | Role | What they receive |
|---|---|---|
| VR googles using exposure sham program | Placebo comparator | The study groups will receive VR googles and the sham program Receives: Device: Placebo comparator: VR googles and the non reality experience |
| VR googles and the real VR program experience. | Active comparator | The study group will receive the VR googles and the real VR program experience. Receives: Device: Active Comparator: VR googles and the real VR program to enter act with and experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of surgery until 48 hours after surgery or discharge, whichever comes first
Secondary outcomes (4)
Total Opioid Consumption
The investigators measured total opioid consumption converted to morphine milligram equivalents (MME).
Measured: End of surgery to 72 hours after surgery.
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.
Measured: 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.
Measured: 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.
Measured: One week (7 days) after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start3 Aug 2020
- Primary completion25 Apr 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sabry Ayad, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416555
- Sponsor's protocol ID
- 19-769
- Other IDs
- R44DA049640
- Status last verified
- Aug 2023
- First submitted
- 27 May 2020
- Last updated
- 27 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 37678233
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Distraction for Reduction in Acute Postoperative Pain
- ClinicalTrials.gov ID
- NCT04416555
- Acronym / sponsor ID
- 19-769
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 27 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| VR googles using exposure sham program | Placebo comparator | Device: Placebo comparator: VR googles and the non reality experienceThe study groups will receive VR googles and the sham program |
| VR googles and the real VR program experience. | Active comparator | Device: Active Comparator: VR googles and the real VR program to enter act with and experienceThe study group will receive the VR googles and the real VR program experience. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Placebo comparator: VR googles and the non reality experienceparallel assignment (this arm will receive a static presentation in the same device) | Device | VR googles using exposure sham program |
| Active Comparator: VR googles and the real VR program to enter act with and experienceParallel assignment (this arm will receive the full immersive virtual reality experience | Device | VR googles and the real VR program experience. |
Primary outcome
Pain Scores (Numerical Rating Scale)
Time frame: 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.
4 secondary outcomes
Total Opioid Consumption
Time frame: End of surgery to 72 hours after surgery.
Time Weighted Average Pain Score
Time frame: End of surgery to 48 hours after surgery
Perception of Video System Usability
Time frame: Once between last intervention time and hospital discharge (up to 8 days after end of surgery)
Post Discharge Analgesia.
Time frame: One week (7 days) after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37678233Araujo-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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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.
Sabry Ayad, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: VR googles and the real VR program to enter act with and experience in people with Postoperative Pain, run by The Cleveland Clinic 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 5 inclusion and 7 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 27 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Scores (Numerical Rating Scale) (time frame: From the end of surgery until 48 hours after surgery or discharge, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416555, which also lists 1 linked publication.
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 27 Nov 2023.