Pain Management During Office Laryngeal ProceduresNCT05218967
Virtual Reality in Laryngology
A study testing Virtual Reality Headset in people with Pain Management During Office Laryngeal Procedures, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to compare patient's pain and anxiety undergoing laryngeal procedures and esophageal manometry while wearing a VR headset to standard of care. It is hypothesized that patient's using the VR headset during the procedure will have reduced pain and anxiety as compared to their standard of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management During Office Laryngeal Procedures
- What is being tested?
- Virtual Reality Headset
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2022to 8 Aug 2022
- 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
- Adult patients (18 or older)
- Patients scheduled for IOAEP, including laryngeal biopsies, percutaneous injection laryngoplasty, KTP ablation of hemorrhagic polyps and respiratory papilloma, and transnasal esophagoscopy (TNE), and esophageal manometry.
Who cannot join
- Patients under 18 years of age
- Patients unable to consent
- Non-English-speaking patients
- Patients who have undergone prior IOAEP
- Patients who have used any psychotropic or analgesic medication within the last 24 hours due to the possible confounding effect on pain or anxiety perception
- Patients with motion sickness or uncorrected visual impairment (legal blindness)
- Patients with past medical history of seizures or visual abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality as a Distraction Intervention for Pain Management During Office Laryngeal Procedures: Randomized Single Blinded Clinical Trial
The purpose of this study is to compare patient's pain and anxiety undergoing laryngeal procedures and esophageal manometry while wearing a VR headset to standard of care. It is hypothesized that patient's using the VR headset during the procedure will have reduced pain and anxiety as compared to their standard of care counterparts because the VR environment will distract them from their procedure.
Read the detailed description
This is a prospective randomized controlled trial, comparing patients' pain and anxiety experience while wearing a VR headset and receiving standard analgesia during In-office aerodigestive procedures (IOAEP) to patients' experience receiving standard analgesia only during IOAEP.
- Being tested
- Virtual Reality Headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetOther
A head-worn apparatus that completely covers the eyes for an immersive 3D experience. The VR headset will be worn during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| In-office procedure with VR-assistance | Experimental | Not described Receives: Other: Virtual Reality Headset |
| In-office procedure without VR-assistance | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during procedure, as measured by the McGill Pain Questionnaire
individually rated pain descriptors with 11 addressing sensory pain and 4 focusing on affective components of pain. Each item is rated on a 4-point scale that ranges from none to severe.
Measured: During Procedure
Anxiety during the procedure , as measured by the spielberger State-Trait Anxiety Inventory (SF- STAI)
The STAI consists of 6 questions concerning patient's current state of anxiety with responses ranging from (1) never to almost always (4).
Measured: During Procedure
Post Procedure Patient Questionnaire
Patients will be asked if they would repeat the procedure again on a scale of 1-5 with 1 being never and 5 being always.
Measured: Immediately After Procedure
Physician Questionnaire
Clinicians will fill out a short 6 question survey about the use of VR during their procedure. The survey is a short 6 item questionnaire inquiring about difficulty and success of the procedure, perceived patients' discomfort, observed patient agitation, interference and benefit of the VR headset. These questions will be answered using a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Immediately After Procedure
Heart rate
Heart rate will will be measured through AD instruments PowerLab.
Measured: Measures will be recorded immediately before and immediately after the procedure.
Temperature
Temperature will be measured through AD instruments PowerLab
Measured: Measures will be recorded immediately before and immediately after the procedure.
Galvanic Skin Activity
Galvanic Skin Activity will be measured through AD instruments PowerLab
Measured: Measures will be recorded immediately before and immediately after the procedure.
Pain as measured by the Visual Analog Scale
Visual Analog Pain Scale measured pain on range from 0-100 (0 is no pain and 100 is max pain) about time of pain, unpleasantness, average pain, and worst pain on a scale of 0-100.
Measured: Measures will be recorded immediately after the procedure.
Upper Esophageal Sphincter Pressure
Upper Esophageal Sphincter Pressure will be measured through the probe inserted during the High Resolution Manometry
Measured: During the Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start14 Feb 2022
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Management During Office Laryngeal ProceduresStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anais Rameau, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218967
- Sponsor's protocol ID
- 20-01021300
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Distraction Intervention for Pain Management During Office Laryngeal Procedures: Randomized Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05218967
- Acronym / sponsor ID
- 20-01021300
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 1 Feb 2022 (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 this study is to compare patient's pain and anxiety undergoing laryngeal procedures and esophageal manometry while wearing a VR headset to standard of care. It is hypothesized that patient's using the VR headset during the procedure will have reduced pain and anxiety as compared to their standard of care counterparts because the VR environment will distract them from their procedure.
Detailed description
This is a prospective randomized controlled trial, comparing patients' pain and anxiety experience while wearing a VR headset and receiving standard analgesia during In-office aerodigestive procedures (IOAEP) to patients' experience receiving standard analgesia only during IOAEP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-office procedure with VR-assistance | Experimental | Other: Virtual Reality Headset |
| In-office procedure without VR-assistance | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18 or older)
- Patients scheduled for IOAEP, including laryngeal biopsies, percutaneous injection laryngoplasty, KTP ablation of hemorrhagic polyps and respiratory papilloma, and transnasal esophagoscopy (TNE), and esophageal manometry.
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- Patients unable to consent
- Non-English-speaking patients
- Patients who have undergone prior IOAEP
- Patients who have used any psychotropic or analgesic medication within the last 24 hours due to the possible confounding effect on pain or anxiety perception
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 |
|---|---|---|
| Virtual Reality HeadsetA head-worn apparatus that completely covers the eyes for an immersive 3D experience. The VR headset will be worn during the procedure. | Other | In-office procedure with VR-assistance |
Primary outcome
Pain during procedure, as measured by the McGill Pain Questionnaire
Time frame: During Procedure
individually rated pain descriptors with 11 addressing sensory pain and 4 focusing on affective components of pain. Each item is rated on a 4-point scale that ranges from none to severe.
Anxiety during the procedure , as measured by the spielberger State-Trait Anxiety Inventory (SF- STAI)
Time frame: During Procedure
The STAI consists of 6 questions concerning patient's current state of anxiety with responses ranging from (1) never to almost always (4).
Post Procedure Patient Questionnaire
Time frame: Immediately After Procedure
Patients will be asked if they would repeat the procedure again on a scale of 1-5 with 1 being never and 5 being always.
Physician Questionnaire
Time frame: Immediately After Procedure
Clinicians will fill out a short 6 question survey about the use of VR during their procedure. The survey is a short 6 item questionnaire inquiring about difficulty and success of the procedure, perceived patients' discomfort, observed patient agitation, interference and benefit of the VR headset. These questions will be answered using a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Heart rate
Time frame: Measures will be recorded immediately before and immediately after the procedure.
Heart rate will will be measured through AD instruments PowerLab.
Temperature
Time frame: Measures will be recorded immediately before and immediately after the procedure.
Temperature will be measured through AD instruments PowerLab
Galvanic Skin Activity
Time frame: Measures will be recorded immediately before and immediately after the procedure.
Galvanic Skin Activity will be measured through AD instruments PowerLab
Pain as measured by the Visual Analog Scale
Time frame: Measures will be recorded immediately after the procedure.
Visual Analog Pain Scale measured pain on range from 0-100 (0 is no pain and 100 is max pain) about time of pain, unpleasantness, average pain, and worst pain on a scale of 0-100.
Upper Esophageal Sphincter Pressure
Time frame: During the Procedure
Upper Esophageal Sphincter Pressure will be measured through the probe inserted during the High Resolution Manometry
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 22 Feb 2024.
- Individual participant dataSharing planned: No
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.
Anais Rameau, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset in people with Pain Management During Office Laryngeal Procedures, run by Weill Medical College of Cornell University 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 2 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 22 Feb 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?
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 during procedure, as measured by the McGill Pain Questionnaire (time frame: During Procedure). The study lists 9 primary outcomes in all. 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 22 Feb 2024.