SalpingographyDaphnéNCT05036772
Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)
A study testing Virtual reality in people with Salpingography and Virtual Reality Exposure Therapy, run by Poitiers University Hospital at 1 site in France.
Trial summary
Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Salpingography, Virtual Reality Exposure Therapy, Virtual Reality
- 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
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2022to 8 Mar 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years old
- patients with a prescription for hysterosalpingography
- patients able to answer the questionnaire independently (French-speaking or understanding French)
- informed consent, signed by the patient
- patients benefiting from a social security scheme or benefiting through a third party
Who cannot join
- patients with a contraindication to virtual reality headset.
- refusal to participate in the study
- Contraindication to the realization of hysterosalpingography (pregnancy / lactation or infection)
- patient under guardianship, curatorship or subordination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.
Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination
Read the detailed description
In France, 1 couples out of 5 consults for suspected infertility. Hysterosalpingography is the first line diagnostic examination in this course and can sometimes be therapeutic. This gynecological examination is invasive in nature, this exam requires an administration of iodinated contrast product by the endocavitary route.
Hysterosalpingography is the most painful examination in this treatment path and pain's assessment is classified as strong by the French National Authority for Health (Haute Autérité de Santé) and anxiety-inducing. For these patients, drug analgesic treatments remain ineffective or contraindicated in outpatient mode. Ionizing irradiation is a constraint that makes hypnosis unsuitable.
Several studies show the contribution of a virtual reality headset in reducing pain and anxiety by inducing patients in an hypnotic environment. This tool standardizes interventions based on changes in consciousness. It is an easy-to-use, non-drug analgesia with few side effects and inexpensive.
The environment offered by this medical device is based on evidence to peacefully escort patients on a journey of natural elements. Calm music is made up of key elements of musical therapy. A medical anesthesiologist and hypnotherapist wrote the hypnotic induction. And, the voice is the one of an experienced sociologist in practice. A simple meditation modeled on heart synchronization sets a persistent goal during this immersion.
- Conditions
- Salpingography, Virtual Reality Exposure Therapy, Virtual Reality, Pain, Anxiety
- Being tested
- Virtual reality
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice | No intervention | The control arm is supported according to the usual practice. The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography |
| Interventionnal | Experimental | The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography. Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (EVA)
The patient rates her pain level between 0 and 10. The standard question is: "From 0 to 10, with 0 absence of pain and 10 maximum pain, how much will you rate the maximum pain experienced during your examination?"
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
anxiety assessment
State Trait Inventory Anxiety (STAI Y-A) anxiety assessment questionnaire
Measured: through study completion, an average of 1 year
Dosimetry
Collection of the dose report produced surface in mGy.cm²
Measured: through study completion, an average of 1 year
Time of exam
Measurement of the time in minutes between the first shot and the last shot (the late evacuation shot will not be taken into account)
Measured: through study completion, an average of 1 year
- Cybersickness evaluation
simplified Virtual Reality Sickness Questionnaire (VRSQ) cybersickness scale. (Questionnaire in 9 items)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start30 May 2022
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SalpingographyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036772
- Sponsor's protocol ID
- Daphné
- Acronym
- Daphné
- Status last verified
- Mar 2024
- First submitted
- 5 Jul 2021
- Last updated
- 3 Dec 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.
- ClinicalTrials.gov ID
- NCT05036772
- Acronym / sponsor ID
- Daphné / Daphné
- Conditions
- Salpingography, Virtual Reality Exposure Therapy, Virtual Reality, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 8 Sep 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.
Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination
Detailed description
In France, 1 couples out of 5 consults for suspected infertility. Hysterosalpingography is the first line diagnostic examination in this course and can sometimes be therapeutic. This gynecological examination is invasive in nature, this exam requires an administration of iodinated contrast product by the endocavitary route.
Hysterosalpingography is the most painful examination in this treatment path and pain's assessment is classified as strong by the French National Authority for Health (Haute Autérité de Santé) and anxiety-inducing. For these patients, drug analgesic treatments remain ineffective or contraindicated in outpatient mode. Ionizing irradiation is a constraint that makes hypnosis unsuitable.
Several studies show the contribution of a virtual reality headset in reducing pain and anxiety by inducing patients in an hypnotic environment. This tool standardizes interventions based on changes in consciousness. It is an easy-to-use, non-drug analgesia with few side effects and inexpensive.
The environment offered by this medical device is based on evidence to peacefully escort patients on a journey of natural elements. Calm music is made up of key elements of musical therapy. A medical anesthesiologist and hypnotherapist wrote the hypnotic induction. And, the voice is the one of an experienced sociologist in practice. A simple meditation modeled on heart synchronization sets a persistent goal during this immersion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Practice | No intervention | –The control arm is supported according to the usual practice. The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography |
| Interventionnal | Experimental | Device: Virtual realityThe experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients over 18 years old
- patients with a prescription for hysterosalpingography
- patients able to answer the questionnaire independently (French-speaking or understanding French)
- informed consent, signed by the patient
- patients benefiting from a social security scheme or benefiting through a third party
Key exclusion criteria (4 listed)
- patients with a contraindication to virtual reality headset.
- refusal to participate in the study
- Contraindication to the realization of hysterosalpingography (pregnancy / lactation or infection)
- patient under guardianship, curatorship or subordination
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 experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography. | Device | Interventionnal |
Primary outcome
visual analog scale (EVA)
Time frame: through study completion, an average of 1 year
The patient rates her pain level between 0 and 10. The standard question is: "From 0 to 10, with 0 absence of pain and 10 maximum pain, how much will you rate the maximum pain experienced during your examination?"
4 secondary outcomes
anxiety assessment
Time frame: through study completion, an average of 1 year
Dosimetry
Time frame: through study completion, an average of 1 year
Time of exam
Time frame: through study completion, an average of 1 year
- Cybersickness evaluation
Time frame: through study completion, an average of 1 year
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 3 Dec 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.
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 in people with Salpingography and Virtual Reality Exposure Therapy, run by Poitiers University Hospital at 1 site in France.
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 4 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 3 Dec 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 France. 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?
visual analog scale (EVA) (time frame: through study completion, an average of 1 year). 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 3 Dec 2024.