Hip Pain ChronicNCT05868369
The Effectiveness of Immersive Virtual Reality as a Pain Control Modality After Hip Arthroscopy
A study testing iVR Group and Standard pain management regimen in people with Hip Pain Chronic, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
1. The purpose of the research is to assess the efficacy of postoperative immersive virtual reality (iVR) compared to a standard multimodal pain regimen including opioids and a local block on acute postoperative pain management following hip arthroscopy 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Pain Chronic
- What is being tested?
- iVR Group and Standard pain management regimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 25 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older with hip pathology
- Failed non-operative treatment of hip pathology
- Undergoing primary, elective and isolated hip arthroscopy for their hip pathology
- Complete pre-operative and post-operative questionnaires
Who cannot join
- Minors (17 years of age and younger)
- Traumatic injuries undergoing emergent surgery
- Undergoing revision hip arthroscopic surgery
- Do not complete pre-operative and post-operative questionnaires
- Patients not able to undergo elective surgery
- Pregnant women
- Prisoners
- Patients with conditions that interfere with VR usage including: history of seizure or epilepsy, facial injury precluding safe placement of headset, visual impairment impacting ability to visualize VR images, hearing impairment impacting ability to follow audio instructions
Trial locations and contacts
1 site in 1 country.
About this study
- The purpose of the research is to assess the efficacy of postoperative immersive virtual reality (iVR) compared to a standard multimodal pain regimen including opioids and a local block on acute postoperative pain management following hip arthroscopy
- The primary research procedures are medical record review for demographic information, head-mounted immersive virtual reality experience in PACU, and pre-operative and post-operative surveys
- The study will enroll adult patients of all ages undergoing elective hip arthroscopy procedures for any diagnosis
Read the detailed description
The overall purpose of this prospective matched cohort investigation is to assess the efficacy of postoperative iVR compared to a standard multimodal pain regimen including opioids, on acute postoperative pain management following hip arthroscopy. The goal is to determine whether iVR in the immediate post-operative ambulatory setting would have any effect on subjective pain, anxiety, and nausea scores or on patients' opioid consumption. The primary objective of this study is to evaluate the effects of administering a head-mounted immersive virtual reality (iVR) experience to control postoperative pain and nausea in patients undergoing hip arthroscopy. The secondary objective of this study is to evaluate the effectiveness of specific iVR modules in pain perception and decreasing overall opioid use for post-operative pain control. We will prospectively compare a cohort of primary hip arthroscopy patients who receive postoperative iVR therapy in addition to the standard multimodal pain regimen (including a preoperative local field block) with a matched cohort of hip arthroscopy patients who receive only the standard regimen (including field block) in the acute postoperative ambulatory setting. On the day of surgery, the iVR group will receive a 30-minute sessions or "dose" of iVR therapy in the ambulatory post-anesthesia care unit (PACU) during their stay in addition to the standard postoperative pain protocol (including a pre-operative local field block). The three distraction-based or skills-based iVR modules will consist of either 1) Mindful Escape; 2) Empowered Breathing; or 3) Relaxation videos. The iVR group will be sub-randomized into receiving only one of the three types of modules. The modules will start approximately 30 minutes upon arriving in PACU and will last approximately 30 minutes. Both groups will receive the standard postoperative pain protocol on an as needed basis.
The duration of the study is three weeks (pre-operative visit, operative day, and first post-operative visit).
Patients will be screened and enrolled at their pre-operative visit. Included patients will be consented and will fill out the pre-operative questionnaires in order to provide baseline data. They will be randomized into the control group or the iVR therapy group. On the day of surgery, they will undergo their local field block by their anesthesiologist pre-operatively, undergo their hip arthroscopy procedure as indicated by their surgeon, and undergo their VR therapy in PACU as described above. They will be asked for their pain scores when leaving PACU, and their opioid medication usage during PACU will be recorded. Post-operative questionnaires will also be completed prior to discharge from PACU and at the first post-op visit.
The study involves participation at a single timepoint only. The study procedures to be done are listed below: Virtual Reality Therapy in PACU performed once as described above.
- Conditions
- Hip Pain Chronic
- Being tested
- iVR Group, Standard pain management regimen
- Keywords
- virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iVR GroupDevice
On the day of surgery, the iVR group will receive a 30-minute sessions or "dose" of iVR therapy in the ambulatory post-anesthesia care unit (PACU) during their stay. The three distraction-based or skills-based iVR modules will consist of either 1) Mindful Escape; 2) Empowered Breathing; or 3) Relaxation videos. The iVR group will be sub-randomized into receiving only one of the three types of modules. The modules will start approximately 30 minutes upon arriving in PACU and will last approximately 30 minutes.
Standard pain management regimenDrug
In the ambulatory post-anesthesia care unit (PACU) during their stay with have standard postoperative pain protocol (including a pre-operative local field block).
| Study group | Role | What they receive |
|---|---|---|
| Standard regimen +iVR Group | Experimental | postoperative iVR therapy in addition to the standard multimodal pain regimen (including a preoperative local field block Receives: Device: iVR Group; Drug: Standard pain management regimen |
| Standard regimen | Active comparator | hip arthroscopy patients who receive only the standard regimen (including field block) in the acute postoperative ambulatory setting Receives: Drug: Standard pain management regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain visual analog scale (VAS)
subjects rate their pain from 0-10, 0 being the least and 10 being the worst.
Measured: one time at Day 1 post operative
Secondary outcomes (2)
Anxiety PACU questionnaire
On a scale 1-9 1 being the least and 9 being the worst
Measured: one time Day 1 of surgery post-op
Nausea PACU Questionnaire
On a scale none, slight, moderate and sever.
Measured: one time Day 1 of surgery post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Nov 2023
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain ChronicStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Banffy, MD, Cedars-Sinai Medical Center
- Investigators
- Karen Ladnier, MS, Study director, Cedar -Sinai Kerlan jobe orthopedic institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868369
- Sponsor's protocol ID
- STUDY00002535
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Immersive Virtual Reality as a Pain Control Modality After Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT05868369
- Acronym / sponsor ID
- STUDY00002535
- Conditions
- Hip Pain Chronic
- Keywords
- virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 22 May 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.
- The purpose of the research is to assess the efficacy of postoperative immersive virtual reality (iVR) compared to a standard multimodal pain regimen including opioids and a local block on acute postoperative pain management following hip arthroscopy
- The primary research procedures are medical record review for demographic information, head-mounted immersive virtual reality experience in PACU, and pre-operative and post-operative surveys
- The study will enroll adult patients of all ages undergoing elective hip arthroscopy procedures for any diagnosis
Detailed description
The overall purpose of this prospective matched cohort investigation is to assess the efficacy of postoperative iVR compared to a standard multimodal pain regimen including opioids, on acute postoperative pain management following hip arthroscopy. The goal is to determine whether iVR in the immediate post-operative ambulatory setting would have any effect on subjective pain, anxiety, and nausea scores or on patients' opioid consumption. The primary objective of this study is to evaluate the effects of administering a head-mounted immersive virtual reality (iVR) experience to control postoperative pain and nausea in patients undergoing hip arthroscopy. The secondary objective of this study is to evaluate the effectiveness of specific iVR modules in pain perception and decreasing overall opioid use for post-operative pain control. We will prospectively compare a cohort of primary hip arthroscopy patients who receive postoperative iVR therapy in addition to the standard multimodal pain regimen (including a preoperative local field block) with a matched cohort of hip arthroscopy patients who receive only the standard regimen (including field block) in the acute postoperative ambulatory setting. On the day of surgery, the iVR group will receive a 30-minute sessions or "dose" of iVR therapy in the ambulatory post-anesthesia care unit (PACU) during their stay in addition to the standard postoperative pain protocol (including a pre-operative local field block). The three distraction-based or skills-based iVR modules will consist of either 1) Mindful Escape; 2) Empowered Breathing; or 3) Relaxation videos. The iVR group will be sub-randomized into receiving only one of the three types of modules. The modules will start approximately 30 minutes upon arriving in PACU and will last approximately 30 minutes. Both groups will receive the standard postoperative pain protocol on an as needed basis.
The duration of the study is three weeks (pre-operative visit, operative day, and first post-operative visit).
Patients will be screened and enrolled at their pre-operative visit. Included patients will be consented and will fill out the pre-operative questionnaires in order to provide baseline data. They will be randomized into the control group or the iVR therapy group. On the day of surgery, they will undergo their local field block by their anesthesiologist pre-operatively, undergo their hip arthroscopy procedure as indicated by their surgeon, and undergo their VR therapy in PACU as described above. They will be asked for their pain scores when leaving PACU, and their opioid medication usage during PACU will be recorded. Post-operative questionnaires will also be completed prior to discharge from PACU and at the first post-op visit.
The study involves participation at a single timepoint only. The study procedures to be done are listed below: Virtual Reality Therapy in PACU performed once as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard regimen +iVR Group | Experimental | Device: iVR Group, Drug: Standard pain management regimenpostoperative iVR therapy in addition to the standard multimodal pain regimen (including a preoperative local field block |
| Standard regimen | Active comparator | Drug: Standard pain management regimenhip arthroscopy patients who receive only the standard regimen (including field block) in the acute postoperative ambulatory setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years of age or older with hip pathology
- Failed non-operative treatment of hip pathology
- Undergoing primary, elective and isolated hip arthroscopy for their hip pathology
- Complete pre-operative and post-operative questionnaires
Key exclusion criteria (8 listed)
- Minors (17 years of age and younger)
- Traumatic injuries undergoing emergent surgery
- Undergoing revision hip arthroscopic surgery
- Do not complete pre-operative and post-operative questionnaires
- Patients not able to undergo elective 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 |
|---|---|---|
| iVR GroupOn the day of surgery, the iVR group will receive a 30-minute sessions or "dose" of iVR therapy in the ambulatory post-anesthesia care unit (PACU) during their stay. The three distraction-based or skills-based iVR modules will consist of either 1) Mindful Escape; 2) Empowered Breathing; or 3) Relaxation videos. The iVR group will be sub-randomized into receiving only one of the three types of modules. The modules will start approximately 30 minutes upon arriving in PACU and will last approximately 30 minutes. | Device | Standard regimen +iVR Group |
| Standard pain management regimenIn the ambulatory post-anesthesia care unit (PACU) during their stay with have standard postoperative pain protocol (including a pre-operative local field block). | Drug | Standard regimen, Standard regimen +iVR Group |
Primary outcome
Pain visual analog scale (VAS)
Time frame: one time at Day 1 post operative
subjects rate their pain from 0-10, 0 being the least and 10 being the worst.
2 secondary outcomes
Anxiety PACU questionnaire
Time frame: one time Day 1 of surgery post-op
Nausea PACU Questionnaire
Time frame: one time Day 1 of surgery post-op
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 4 May 2026.
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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.
Karen Ladnier, MS study director
Cedar -Sinai Kerlan jobe orthopedic institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iVR Group and Standard pain management regimen in people with Hip Pain Chronic, run by Cedars-Sinai Medical Center 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 8 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 4 May 2026. 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?
Pain visual analog scale (VAS) (time frame: one time at Day 1 post operative). 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 4 May 2026.