Pain and HysteroscopyVRNCT04802460
Virtual Reality Effects on Pain During Hysteroscopy Hysteroscopy: A Randomized Control Trial
A study testing Virtual reality headset (The Guided Meditation VR App through Oculus Go headset) in people with Pain and Hysteroscopy, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain and Hysteroscopy
- What is being tested?
- Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 2 Feb 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria will be women over the age of 18 presenting for office hysteroscopy.
Who cannot join
- Exclusion criteria included patients with visual or auditory impairment that would interfere with their ability to use the virtual reality set, English language non-fluency, history of opioid dependence/abuse, current narcotic use, or desire for narcotic use during the procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
MHRI IRB
Washington D.C., District of Columbia, 20010
About this study
Official title: Virtual Reality Effects on Acute Pain During Office Hysteroscopy: A Randomized Control Study
The Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.
Read the detailed description
The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).
A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.
- Conditions
- Pain and Hysteroscopy
- Being tested
- Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)Device
Patients assigned to the VR condition will engage with the VR using The Guided Meditation VR App through Oculus Go headset. They will enjoy up to a 10 minute video of an environment of their choosing. During this video they will listen to calming music and a guided meditation session.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | Patients assigned to the VR group will be engaged with the VR using a publicly available VR set. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office. Receives: Device: Virtual reality headset (The Guided Meditation VR App through Oculus Go headset) |
| control arm | No intervention | Patients in the control arm will undergo standard of care office hysteroscopy. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scale
The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).
Measured: 10 minutes
Secondary outcomes (1)
heart rate changes
The secondary outcomes will be change in pain score and change in participant's HR throughout the procedure to assess for sympathetic evidence of pain and anxiety.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 May 2020
- Primary completion20 Nov 2020
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain and HysteroscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802460
- Sponsor's protocol ID
- STUDY00001687
- Acronym
- VR
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 17 Mar 2021
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Effects on Acute Pain During Office Hysteroscopy: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT04802460
- Acronym / sponsor ID
- VR / STUDY00001687
- Conditions
- Pain and Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 17 Mar 2021 (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 Objective of this study is to compare pain levels in women undergoing office-based hysteroscopies using Virtual Reality versus control in a randomized control prospective trial.
Detailed description
The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).
A secondary aim will be to monitor heart rate for patients using virtual reality versus the controls during the procedure. Another secondary aim will be to time the length of the procedure as it is possible if pain perception is reduced, the procedure can be completed faster. Lastly, we would also want to evaluate both patient and surgeon satisfaction of the procedure with or without virtual reality by using a satisfaction questionnaire to assess for patients satisfaction with the procedure, with the VR intervention, perceived realism of VR game, and measure simulator sickness related to the VR game.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Device: Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)Patients assigned to the VR group will be engaged with the VR using a publicly available VR set. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office. |
| control arm | No intervention | –Patients in the control arm will undergo standard of care office hysteroscopy. Both study groups will be directed to take 800mg ibuprofen 1 hour prior to scheduled surgery as standard pain management in our office. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will be women over the age of 18 presenting for office hysteroscopy.
Key exclusion criteria (1 listed)
- Exclusion criteria included patients with visual or auditory impairment that would interfere with their ability to use the virtual reality set, English language non-fluency, history of opioid dependence/abuse, current narcotic use, or desire for narcotic use during the procedure.
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 headset (The Guided Meditation VR App through Oculus Go headset)Patients assigned to the VR condition will engage with the VR using The Guided Meditation VR App through Oculus Go headset. They will enjoy up to a 10 minute video of an environment of their choosing. During this video they will listen to calming music and a guided meditation session. | Device | virtual reality |
Primary outcome
pain scale
Time frame: 10 minutes
The primary aim of this study is to see if virtual reality can decrease pain intensity during office hysteroscopies using a 100mm Visual Analogue Scale (VAS).
1 secondary outcome
heart rate changes
Time frame: 10 minutes
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 17 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (The Guided Meditation VR App through Oculus Go headset) in people with Pain and Hysteroscopy, run by Medstar Health Research Institute 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: finished, as of the sponsor's last update on 17 Mar 2021. 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 scale (time frame: 10 minutes). 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 17 Mar 2021.