Pain, AcuteVRPADNCT04721587
Virtual Reality for Pain and Anxiety Distraction Strategy on Office Hysteroscopy
A study testing Virtual Reality in people with Pain, Acute and Anxiety, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. 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, Acute, Anxiety
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2020to 30 Jun 2023
- 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
- Being over 18 years
- Understand and accept the study procedures
- Sign the informed consent.
- Indication of outpatient hysteroscopy according to the care protocols of the center
- Not taking drugs for the treatment of anxiety.
Who cannot join
- Not being able to understand the nature of the study and / or the procedures to be followed
- Not signing the informed consent
- Be under the age of 18
- Pregnancy
- Being diagnosed with anxiety disorder or being treated with anxiolytics
- Patients suffering from vertigo
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- Patients with epilepsy
- Active ear infection
- Patients with diagnosed hypertension
- Patients with cardiovascular disease
- Patients with psychosis or severe mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Virtual Reality as a Pain and Anxiety Distraction Strategy on Office Hysteroscopy
Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. The "see and treat" strategy allows diagnosis and treatment in the same surgical act, and gives the technique a high resolution capacity, reducing the number of procedures the patient must undergo. The technological development of instruments has made it possible to have small-caliber endoscopic systems that have made this technique possible in an outpatient setting. Outpatient management allows patients to avoid the possible risks and inconveniences associated with the surgical environment, such as the waiting list and the need for anesthesia, as well as an earlier return to their activities of daily life. Despite the high resolution rates, a not inconsiderable percentage of women experience anxiety or pain during outpatient hysteroscopy, and this is the leading cause of treatment failure. In order to improve the tolerance and comfort of the patient, the usefulness of various strategies, both pharmacological and non-pharmacological, has been evaluated for pain reduction, with different results.
Virtual Reality (VR) has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental processes, chronic pruritus or venipuncture. There is no published study to our knowledge that evaluates the usefulness of VR in reducing the levels of anxiety and pain perceived during a hysteroscopic procedure.
The working hypothesis to be evaluated with this study is that the use of a VR device with reproduction of relaxing and distraction environments reduces the perception of pain and anxiety of the patient during an outpatient hysteroscopy.
- Conditions
- Pain, Acute, Anxiety
- Being tested
- Virtual Reality
- Keywords
- Hysteroscopy, Pain, Virtual Reality, Anxiety
- Medical subject headings
- Acute Pain, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The patients of the VR Group will be subjected to the same hysteroscopy technique as the Standard of Care Group, but additionally a VR device will be applied where a distraction VR environment ("Underwater Game") will be reproduced during the exploration
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Office hysteroscopy performed as the standard of care of our Hospital |
| Virtual Reality | Experimental | Office hysteroscopy with the use of VR environment (preprocedure and during procedure) Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Decrease of 1 point or more in the level of pain measured by an 11-point visual analog scale, a validity scale that comprises 11 consecutive values from 0 to 10, with "0" corresponding to no pain and "10" to worst pain imaginable.
Measured: Intraprocedure
Secondary outcomes (3)
Heart Rate
Changes in basal Heart Rate, maximum Heart Rate, mean Heart Rate, and final Heart Rate.
Measured: Intraprocedure
Blood Pressure
Changes in pre and postprocedure blood pressure
Measured: Intraprocedure
Skin conductace
Change between basal and maximum skin conductance levels during pocedure measured by a small sensor placed on two hand fingers. Skin conductance depends directly on the state of relaxation or stress, making it a commonly used and very precise stress indicator.
Measured: Intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start18 Feb 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Psious
- Responsible party
- Sponsor
- Investigators
- Josep Estadella Tarriel, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721587
- Sponsor's protocol ID
- IIBSP-VIR-2019-75
- Acronym
- VRPAD
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2020
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality as a Pain and Anxiety Distraction Strategy on Office Hysteroscopy
- ClinicalTrials.gov ID
- NCT04721587
- Acronym / sponsor ID
- VRPAD / IIBSP-VIR-2019-75
- Conditions
- Pain, Acute, Anxiety
- Keywords
- Hysteroscopy, Pain, Virtual Reality, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Psious
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Jan 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.
Hysteroscopy is a minimally invasive endoscopic technique that allows direct visualization of the uterine cavity and constitutes the gold standard for the diagnosis and treatment of most intrauterine pathology, such as heavy menstrual bleeding, fibroids, endometrial polyps, uterine malformations, etc. The "see and treat" strategy allows diagnosis and treatment in the same surgical act, and gives the technique a high resolution capacity, reducing the number of procedures the patient must undergo. The technological development of instruments has made it possible to have small-caliber endoscopic systems that have made this technique possible in an outpatient setting. Outpatient management allows patients to avoid the possible risks and inconveniences associated with the surgical environment, such as the waiting list and the need for anesthesia, as well as an earlier return to their activities of daily life. Despite the high resolution rates, a not inconsiderable percentage of women experience anxiety or pain during outpatient hysteroscopy, and this is the leading cause of treatment failure. In order to improve the tolerance and comfort of the patient, the usefulness of various strategies, both pharmacological and non-pharmacological, has been evaluated for pain reduction, with different results.
Virtual Reality (VR) has been used successfully to reduce perceived pain in various procedures such as chronic pain, burns, dental processes, chronic pruritus or venipuncture. There is no published study to our knowledge that evaluates the usefulness of VR in reducing the levels of anxiety and pain perceived during a hysteroscopic procedure.
The working hypothesis to be evaluated with this study is that the use of a VR device with reproduction of relaxing and distraction environments reduces the perception of pain and anxiety of the patient during an outpatient hysteroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Office hysteroscopy performed as the standard of care of our Hospital |
| Virtual Reality | Experimental | Device: Virtual RealityOffice hysteroscopy with the use of VR environment (preprocedure and during procedure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being over 18 years
- Understand and accept the study procedures
- Sign the informed consent.
- Indication of outpatient hysteroscopy according to the care protocols of the center
- Not taking drugs for the treatment of anxiety.
Key exclusion criteria (11 listed)
- Not being able to understand the nature of the study and / or the procedures to be followed
- Not signing the informed consent
- Be under the age of 18
- Pregnancy
- Being diagnosed with anxiety disorder or being treated with anxiolytics
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 RealityThe patients of the VR Group will be subjected to the same hysteroscopy technique as the Standard of Care Group, but additionally a VR device will be applied where a distraction VR environment ("Underwater Game") will be reproduced during the exploration | Device | Virtual Reality |
Primary outcome
Pain score
Time frame: Intraprocedure
Decrease of 1 point or more in the level of pain measured by an 11-point visual analog scale, a validity scale that comprises 11 consecutive values from 0 to 10, with "0" corresponding to no pain and "10" to worst pain imaginable.
3 secondary outcomes
Heart Rate
Time frame: Intraprocedure
Blood Pressure
Time frame: Intraprocedure
Skin conductace
Time frame: Intraprocedure
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 20 Dec 2023.
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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.
Josep Estadella Tarriel principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 in people with Pain, Acute and Anxiety, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 11 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 20 Dec 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 Spain. 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 score (time frame: Intraprocedure). 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 20 Dec 2023.