Endometrial CancerNCT06524934
Virtual Reality's Role in See&Treat Hysteroscopy
A study testing Use of virtual reality during the hysteroscopic procedure in people with Endometrial Cancer and Endometrial Diseases, run by Federico II University at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \& treat philosophy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer, Endometrial Diseases, Myoma;Uterus
- What is being tested?
- Use of virtual reality during the hysteroscopic procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2024to 15 Jul 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial
The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \& treat philosophy.
- Being tested
- Use of virtual reality during the hysteroscopic procedure
- Keywords
- Outpatient Hysteroscopy, Virtual Reality Technology, Pain and Anxiety Management, See & Treat
- Medical subject headings
- Endometrial Neoplasms, Uterine Diseases, Myofibroma, Endometrial Hyperplasia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of virtual reality during the hysteroscopic procedureDevice
In VR group patients underwent hysteroscopy with standard care but the addition of VRT provided by a VR headset and headphones with the use of a Hypno VR software.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | The patients in this group undergo the procedure using virtual reality. Receives: Device: Use of virtual reality during the hysteroscopic procedure |
| Control group | No intervention | The patients in this group undergo the procedure without the use of virtual reality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pre procedure
Level of pain the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain to 10 corresponding to the worst pain (subjective criteria), before undergoing diagnostic and operative procedures.
Measured: 1 minute before the procedure
Anxiety pre procedure
Level of anxiety the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no anxiety to 10 corresponding to the worst anxiety (subjective criteria), before undergoing diagnostic and operative procedures.
Measured: 1 minute before the procedure
Pain post procedure
Level of pain reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst pain (subjective criteria), during diagnostic and operative procedures.
Measured: 1 minute after the procedure
Anxiety post procedure
Level of anxiety reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst anxiety (subjective criteria), during diagnostic and operative procedures.
Measured: 1 minute after the procedure
Heart rate (HR) pre procedure
Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Measured: 1 minute before the procedure
Respiratory rate (RR) pre procedure
Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Measured: 1 minute before the procedure
Heart rate (HR) during procedure
Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
Measured: 5 minutes after the start of the procedure
Respiratory rate (RR) during procedure
Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
Measured: 5 minutes after the start of the procedure
Secondary outcomes (4)
Suspension rate of procedure
Procedure completion and suspension rate (defined as the proportion of suspended procedures for any reasons)
Measured: During procedure
Time of procedure
Recording the time of procedure
Measured: During procedure
Satisfaction rate
Satisfaction rate (Virtual reality group: desire to use the headset again in the future / Control group: desire to use headset if they could)
Measured: 5 minutes after the procedure
Side effects
Reported side effects
Measured: 5 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start16 May 2024
- Primary completion6 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Federico II 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brunella Zizolfi, Federico II University
- Investigators
- Brunella Ms Zizolfi, AssProfessor, Principal investigator, University Federico II of Naples - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524934
- Sponsor's protocol ID
- 112/24
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 29 Jul 2024
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality Technology in the Era of See & Treat Hysteroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06524934
- Acronym / sponsor ID
- 112/24
- Keywords
- Outpatient Hysteroscopy, Virtual Reality Technology, Pain and Anxiety Management, See & Treat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 6 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 29 Jul 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.
The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \& treat philosophy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Device: Use of virtual reality during the hysteroscopic procedureThe patients in this group undergo the procedure using virtual reality. |
| Control group | No intervention | –The patients in this group undergo the procedure without the use of virtual reality. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Use of virtual reality during the hysteroscopic procedureIn VR group patients underwent hysteroscopy with standard care but the addition of VRT provided by a VR headset and headphones with the use of a Hypno VR software. | Device | Case group |
Primary outcome
Pain pre procedure
Time frame: 1 minute before the procedure
Level of pain the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain to 10 corresponding to the worst pain (subjective criteria), before undergoing diagnostic and operative procedures.
Anxiety pre procedure
Time frame: 1 minute before the procedure
Level of anxiety the patient thinks she will experience, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no anxiety to 10 corresponding to the worst anxiety (subjective criteria), before undergoing diagnostic and operative procedures.
Pain post procedure
Time frame: 1 minute after the procedure
Level of pain reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst pain (subjective criteria), during diagnostic and operative procedures.
Anxiety post procedure
Time frame: 1 minute after the procedure
Level of anxiety reported by the patient, expressed on a 10-point numerical rating scale (NRS), from 0 indicating no pain or anxiety, to 10 corresponding to the worst anxiety (subjective criteria), during diagnostic and operative procedures.
Heart rate (HR) pre procedure
Time frame: 1 minute before the procedure
Heart rate (HR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Respiratory rate (RR) pre procedure
Time frame: 1 minute before the procedure
Respiratory rate (RR) collected by a dedicate nurse before diagnostic or operative procedures (objective criteria).
Heart rate (HR) during procedure
Time frame: 5 minutes after the start of the procedure
Heart rate (HR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
Respiratory rate (RR) during procedure
Time frame: 5 minutes after the start of the procedure
Respiratory rate (RR) collected by a dedicate nurse during diagnostic or operative procedures (objective criteria).
4 secondary outcomes
Suspension rate of procedure
Time frame: During procedure
Time of procedure
Time frame: During procedure
Satisfaction rate
Time frame: 5 minutes after the procedure
Side effects
Time frame: 5 minutes after the procedure
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 29 Jul 2024.
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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.
Brunella Ms Zizolfi, AssProfessor principal investigator
University Federico II of Naples - Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of virtual reality during the hysteroscopic procedure in people with Endometrial Cancer and Endometrial Diseases, run by Federico II University at 1 site in Italy.
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 0 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 29 Jul 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 Italy. 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 pre procedure (time frame: 1 minute before the procedure). The study lists 8 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 29 Jul 2024.