Pain, AcutePARVANCT06227039
Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures
A study testing Vibroacoustic stimulation on, Augmented Reality on and Vibroacoustic stimulation off in people with Pain, Acute and Vocal Fold Polyp, run by University of Virginia at 1 site in United States.
Trial summary
In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Vocal Fold Polyp, Vocal Cord Paralysis
- What is being tested?
- Vibroacoustic stimulation on, Augmented Reality on and Vibroacoustic stimulation off
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing office-based laryngology procedure performed at home institution.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UVA Fontaine Research Park Building 415
Charlottesville, Virginia, 22903
James Daniero, MD, 434-924-2040, jjd5h@uvahealth.org
James Daniero, MD
About this study
Official title: Using Augmented Reality With Vibroacoustic Stimulation to Improve the Patient Experience During In-Office Otorhinolaryngology Procedures
In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Vibration and augmented reality (AR) can be used as non-pharmacologic treatment options to treat patient anxiety and pain by using the physiology proposed by the gate-way theory of pain as well as distraction. This study seeks to compare anxiety and pain perception with patient reported survey data, as well as physiologic indicators of stress such as heart rate variability (HRV) within patients undergoing IOPs in a laryngology office with and without vibration and AR treatment.
Read the detailed description
In-office procedures (IOPs) represent a cost-effective and safe alternative to operating room procedures for a myriad of disease processes across medical and surgical specialties. IOPs are performed under local anesthetic without general anesthesia or sedation, resulting in faster and often safer procedures by eliminating risks associated with general anesthesia. IOPs are primarily limited by patient tolerance, as there is a lack of currently available non-pharmacologic treatment options for patient anxiety, stress, discomfort, and pain during these procedures.
The Gate Control Theory of Pain postulates that only a limited amount of simultaneous sensory stimuli can be processed by the central nervous system and therefore non-painful stimuli, such as vibration or virtual distraction (i.e. virtual or augmented reality), can eliminate or lessen the perception of concurrent painful stimuli. The use of these non-painful stimuli has been shown to have clinical utility in the setting of procedures such as percutaneous injections and wound dressing changes.
However, the coupling of multiple sensory distraction techniques has not been described for IOPs. Furthermore, no investigation of sensory distraction techniques to reduce patient discomfort within the field of otolaryngology has been conducted. The focus of the proposed project is to improve patient experience during IOPs by coupling a novel vibroacoustic stimulation device with original AR software applications.
In-office otolaryngology procedures specifically involve using a rigid endoscope or a flexible nasolarynogoscopy to visualize the inside of a patient nose, sinus, posterior oropharynx, and vocal cords. Using these imaging modalities, awake, in-office procedures can be performed. However, these procedures are often very uncomfortable and anxiety producing.
The goal of the study is to determine whether or not wearing an augmented reality headset with a novel game and vibroacoustic simulation device can help reduce anxiety and improve the patient experience of in-office otolaryngology procedures. The device consists of an augmented reality headset worn by the patient, a vibration device that is applied to the patient's neck to help reduce the sensation of the procedure, and a clicker that allows the patient to interact with the augmented reality game environment.
Patients who are undergoing in-office laryngology procedures (procedures on their vocal cords) will be randomized into a control group augmented reality (AR) group, vibration group, and combined AR and vibration group. The control group will wear a sham augmented reality head set during the procedure. The AR group will have a game played on the head set to distract them during the procedure. The patient will interact with the game use a hand held clicker.
Each participant will answer a survey before and after the procedure assessing their anxiety. Each participant will also wear a one-lead EKG to measure their heart rate through the procedure. The subjective and physiological level will be compared between the two groups
- Being tested
- Vibroacoustic stimulation on, Augmented Reality on, Vibroacoustic stimulation off, Augmented reality off
- Medical subject headings
- Acute Pain, Vocal Cord Paralysis, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibroacoustic stimulation onOther
Mechanical stimulus is provided to the patient through a vibroacoustic device via vibration around the neck.
Augmented Reality onOther
Visual stimulus is provided through augmented reality glasses in the form of a game.
Vibroacoustic stimulation offOther
Vibroacoustic device is worn but turned off.
Augmented reality offOther
Augmented reality glasses are worn but turned off.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | This arm will be the current standard of care |
| Vibroacoustic | Experimental | This arm will use the vibroacoustic device to provide a mechanical stimulus to the patient as treatment to reduce pain and anxiety. Augmented reality glasses will be worn but will be turned off. Receives: Other: Vibroacoustic stimulation on; Other: Augmented reality off |
| Augmented Reality | Experimental | This arm will use the augmented reality game to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. Vibroacoustic device will be worn but will be turned off. Receives: Other: Augmented Reality on; Other: Vibroacoustic stimulation off |
| Combination vibroacoustic and augmented reality | Experimental | This arm will use both the augmented reality game and vibroacoustic device to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. Receives: Other: Vibroacoustic stimulation on; Other: Augmented Reality on |
What is being measured
The primary outcome is the main question the study is designed to answer.
Max pain experienced
Visual analog scale rating of max perceived pain during procedure
Measured: measured post-treatment (1 hr).
Average pain experienced
Visual analog scale rating of average perceived pain during procedure
Measured: measured post-treatment (1 hr).
Pain nervousness experienced
Visual analog scale rating of how nervous about pain patient was during procedure
Measured: measured post-treatment (1 hr).
Time spent thinking about pain
Visual analog scale rating of percent of time spent thinking about pain during procedure
Measured: measured post-treatment (1 hr).
Change in heart rate variability during procedure
Difference between heart rate variability during procedure compared with pre-procedure
Measured: calculated post-treatment (1 hr).
Change in maximum heart rate
Difference between maximum heart rate during procedure compared with pre-procedure
Measured: calculated post-treatment (1 hr).
Change in average heart rate
Difference between average heart rate during procedure compared with pre-procedure
Measured: calculated post-treatment (1 hr).
Secondary outcomes (3)
Change is STAI score
Measure change in Stait-Trait anxiety inventory State 5 question score pre and post-procedure.
Measured: calculated post-procedure (1 hr).
Pain catastrophizing score
Pain catastrophizing score
Measured: calculated pre-procedure (1 hr).
Patient satisfaction
Likert scale rating of satisfaction of treatment group
Measured: measured post-treatment (1 hr).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Daniero, MD, University of Virginia
- Investigators
- James J Daniero, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227039
- Sponsor's protocol ID
- HSR210111
- Acronym
- PARVA
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no intention to share individual participant data with other researchers.
Publications
McCarthy M. US health-care system faces cost and insurance crises. Rising costs, growing numbers of uninsured, and quality gaps trouble world's most expensive health-care system. Lancet. 2003 Aug 2;362(9381):375. doi: 10.1016/s0140-6736(03)14057-3. No abstract available.
PubMed 12907006Rice T, Rosenau P, Unruh LY, Barnes AJ, Saltman RB, van Ginneken E. United States of America: health system review. Health Syst Transit. 2013;15(3):1-431.
PubMed 24025796Hoffer EP. The American Health Care System Is Broken. Part 7: How Can We Fix It? Am J Med. 2019 Dec;132(12):1381-1385. doi: 10.1016/j.amjmed.2019.10.003. Epub 2019 Oct 24.
PubMed 31668898Young S, Shapiro FE, Urman RD. Office-based surgery and patient outcomes. Curr Opin Anaesthesiol. 2018 Dec;31(6):707-712. doi: 10.1097/ACO.0000000000000655.
PubMed 30148715Saini AT, Citardi MJ, Yao WC, Luong AU. Office-Based Sinus Surgery. Otolaryngol Clin North Am. 2019 Jun;52(3):473-483. doi: 10.1016/j.otc.2019.02.003. Epub 2019 Mar 22.
PubMed 30905564Shah PD. Patient Safety and Quality for Office-Based Procedures in Otolaryngology. Otolaryngol Clin North Am. 2019 Feb;52(1):89-102. doi: 10.1016/j.otc.2018.08.015. Epub 2018 Sep 22.
PubMed 30249445Braz J, Solorzano C, Wang X, Basbaum AI. Transmitting pain and itch messages: a contemporary view of the spinal cord circuits that generate gate control. Neuron. 2014 May 7;82(3):522-36. doi: 10.1016/j.neuron.2014.01.018.
PubMed 24811377Treede RD. Gain control mechanisms in the nociceptive system. Pain. 2016 Jun;157(6):1199-1204. doi: 10.1097/j.pain.0000000000000499.
PubMed 26817644Zhang Y, Liu S, Zhang YQ, Goulding M, Wang YQ, Ma Q. Timing Mechanisms Underlying Gate Control by Feedforward Inhibition. Neuron. 2018 Sep 5;99(5):941-955.e4. doi: 10.1016/j.neuron.2018.07.026. Epub 2018 Aug 16.
PubMed 30122375Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1.
PubMed 15530291Mally P, Czyz CN, Chan NJ, Wulc AE. Vibration anesthesia for the reduction of pain with facial dermal filler injections. Aesthetic Plast Surg. 2014 Apr;38(2):413-8. doi: 10.1007/s00266-013-0264-4. Epub 2014 Jan 24.
PubMed 24464122Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.
PubMed 22001341Legrain V, Damme SV, Eccleston C, Davis KD, Seminowicz DA, Crombez G. A neurocognitive model of attention to pain: behavioral and neuroimaging evidence. Pain. 2009 Aug;144(3):230-232. doi: 10.1016/j.pain.2009.03.020. Epub 2009 Apr 18. No abstract available.
PubMed 19376654
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Augmented Reality With Vibroacoustic Stimulation to Improve the Patient Experience During In-Office Otorhinolaryngology Procedures
- ClinicalTrials.gov ID
- NCT06227039
- Acronym / sponsor ID
- PARVA / HSR210111
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2024 (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.
In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Vibration and augmented reality (AR) can be used as non-pharmacologic treatment options to treat patient anxiety and pain by using the physiology proposed by the gate-way theory of pain as well as distraction. This study seeks to compare anxiety and pain perception with patient reported survey data, as well as physiologic indicators of stress such as heart rate variability (HRV) within patients undergoing IOPs in a laryngology office with and without vibration and AR treatment.
Detailed description
In-office procedures (IOPs) represent a cost-effective and safe alternative to operating room procedures for a myriad of disease processes across medical and surgical specialties. IOPs are performed under local anesthetic without general anesthesia or sedation, resulting in faster and often safer procedures by eliminating risks associated with general anesthesia. IOPs are primarily limited by patient tolerance, as there is a lack of currently available non-pharmacologic treatment options for patient anxiety, stress, discomfort, and pain during these procedures.
The Gate Control Theory of Pain postulates that only a limited amount of simultaneous sensory stimuli can be processed by the central nervous system and therefore non-painful stimuli, such as vibration or virtual distraction (i.e. virtual or augmented reality), can eliminate or lessen the perception of concurrent painful stimuli. The use of these non-painful stimuli has been shown to have clinical utility in the setting of procedures such as percutaneous injections and wound dressing changes.
However, the coupling of multiple sensory distraction techniques has not been described for IOPs. Furthermore, no investigation of sensory distraction techniques to reduce patient discomfort within the field of otolaryngology has been conducted. The focus of the proposed project is to improve patient experience during IOPs by coupling a novel vibroacoustic stimulation device with original AR software applications.
In-office otolaryngology procedures specifically involve using a rigid endoscope or a flexible nasolarynogoscopy to visualize the inside of a patient nose, sinus, posterior oropharynx, and vocal cords. Using these imaging modalities, awake, in-office procedures can be performed. However, these procedures are often very uncomfortable and anxiety producing.
The goal of the study is to determine whether or not wearing an augmented reality headset with a novel game and vibroacoustic simulation device can help reduce anxiety and improve the patient experience of in-office otolaryngology procedures. The device consists of an augmented reality headset worn by the patient, a vibration device that is applied to the patient's neck to help reduce the sensation of the procedure, and a clicker that allows the patient to interact with the augmented reality game environment.
Patients who are undergoing in-office laryngology procedures (procedures on their vocal cords) will be randomized into a control group augmented reality (AR) group, vibration group, and combined AR and vibration group. The control group will wear a sham augmented reality head set during the procedure. The AR group will have a game played on the head set to distract them during the procedure. The patient will interact with the game use a hand held clicker.
Each participant will answer a survey before and after the procedure assessing their anxiety. Each participant will also wear a one-lead EKG to measure their heart rate through the procedure. The subjective and physiological level will be compared between the two groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –This arm will be the current standard of care |
| Vibroacoustic | Experimental | Other: Vibroacoustic stimulation on, Other: Augmented reality offThis arm will use the vibroacoustic device to provide a mechanical stimulus to the patient as treatment to reduce pain and anxiety. Augmented reality glasses will be worn but will be turned off. |
| Augmented Reality | Experimental | Other: Augmented Reality on, Other: Vibroacoustic stimulation offThis arm will use the augmented reality game to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. Vibroacoustic device will be worn but will be turned off. |
| Combination vibroacoustic and augmented reality | Experimental | Other: Vibroacoustic stimulation on, Other: Augmented Reality onThis arm will use both the augmented reality game and vibroacoustic device to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing office-based laryngology procedure performed at home institution.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Vibroacoustic stimulation onMechanical stimulus is provided to the patient through a vibroacoustic device via vibration around the neck. | Other | Combination vibroacoustic and augmented reality, Vibroacoustic |
| Augmented Reality onVisual stimulus is provided through augmented reality glasses in the form of a game. | Other | Augmented Reality, Combination vibroacoustic and augmented reality |
| Vibroacoustic stimulation offVibroacoustic device is worn but turned off. | Other | Augmented Reality |
| Augmented reality offAugmented reality glasses are worn but turned off. | Other | Vibroacoustic |
Primary outcome
Max pain experienced
Time frame: measured post-treatment (1 hr).
Visual analog scale rating of max perceived pain during procedure
Average pain experienced
Time frame: measured post-treatment (1 hr).
Visual analog scale rating of average perceived pain during procedure
Pain nervousness experienced
Time frame: measured post-treatment (1 hr).
Visual analog scale rating of how nervous about pain patient was during procedure
Time spent thinking about pain
Time frame: measured post-treatment (1 hr).
Visual analog scale rating of percent of time spent thinking about pain during procedure
Change in heart rate variability during procedure
Time frame: calculated post-treatment (1 hr).
Difference between heart rate variability during procedure compared with pre-procedure
Change in maximum heart rate
Time frame: calculated post-treatment (1 hr).
Difference between maximum heart rate during procedure compared with pre-procedure
Change in average heart rate
Time frame: calculated post-treatment (1 hr).
Difference between average heart rate during procedure compared with pre-procedure
3 secondary outcomes
Change is STAI score
Time frame: calculated post-procedure (1 hr).
Pain catastrophizing score
Time frame: calculated pre-procedure (1 hr).
Patient satisfaction
Time frame: measured post-treatment (1 hr).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 12907006McCarthy M. US health-care system faces cost and insurance crises. Rising costs, growing numbers of uninsured, and quality gaps trouble world's most expensive health-care system. Lancet. 2003 Aug 2;362(9381):375. doi: 10.1016/s0140-6736(03)14057-3. No abstract available.
- Background: PubMed 24025796Rice T, Rosenau P, Unruh LY, Barnes AJ, Saltman RB, van Ginneken E. United States of America: health system review. Health Syst Transit. 2013;15(3):1-431.
- Background: PubMed 31668898Hoffer EP. The American Health Care System Is Broken. Part 7: How Can We Fix It? Am J Med. 2019 Dec;132(12):1381-1385. doi: 10.1016/j.amjmed.2019.10.003. Epub 2019 Oct 24.
- Background: PubMed 30148715Young S, Shapiro FE, Urman RD. Office-based surgery and patient outcomes. Curr Opin Anaesthesiol. 2018 Dec;31(6):707-712. doi: 10.1097/ACO.0000000000000655.
- Background: PubMed 30905564Saini AT, Citardi MJ, Yao WC, Luong AU. Office-Based Sinus Surgery. Otolaryngol Clin North Am. 2019 Jun;52(3):473-483. doi: 10.1016/j.otc.2019.02.003. Epub 2019 Mar 22.
- Background: PubMed 30249445Shah PD. Patient Safety and Quality for Office-Based Procedures in Otolaryngology. Otolaryngol Clin North Am. 2019 Feb;52(1):89-102. doi: 10.1016/j.otc.2018.08.015. Epub 2018 Sep 22.
- Background: PubMed 24811377Braz J, Solorzano C, Wang X, Basbaum AI. Transmitting pain and itch messages: a contemporary view of the spinal cord circuits that generate gate control. Neuron. 2014 May 7;82(3):522-36. doi: 10.1016/j.neuron.2014.01.018.
- Background: PubMed 26817644Treede RD. Gain control mechanisms in the nociceptive system. Pain. 2016 Jun;157(6):1199-1204. doi: 10.1097/j.pain.0000000000000499.
- Background: PubMed 30122375Zhang Y, Liu S, Zhang YQ, Goulding M, Wang YQ, Ma Q. Timing Mechanisms Underlying Gate Control by Feedforward Inhibition. Neuron. 2018 Sep 5;99(5):941-955.e4. doi: 10.1016/j.neuron.2018.07.026. Epub 2018 Aug 16.
- Background: PubMed 15530291Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1.
- Background: PubMed 24464122Mally P, Czyz CN, Chan NJ, Wulc AE. Vibration anesthesia for the reduction of pain with facial dermal filler injections. Aesthetic Plast Surg. 2014 Apr;38(2):413-8. doi: 10.1007/s00266-013-0264-4. Epub 2014 Jan 24.
- Background: PubMed 22001341Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.
- Individual participant dataSharing planned: No. There is no intention to share individual participant data with other researchers.
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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.
James J Daniero, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibroacoustic stimulation on, Augmented Reality on and Vibroacoustic stimulation off in people with Pain, Acute and Vocal Fold Polyp, run by University of Virginia 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James J Daniero, MD (4349242040, jjd5h@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Max pain experienced (time frame: measured post-treatment (1 hr).). The study lists 7 primary outcomes in all. 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 NCT06227039, which also lists 13 linked publications.
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 26 Jan 2024.