Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné) (Daphné)
Primary Purpose
Salpingography, Virtual Reality Exposure Therapy, Virtual Reality
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Salpingography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier UniversitaireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Practice
Interventionnal
Arm Description
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
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
Outcomes
Primary Outcome Measures
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?"
Secondary Outcome Measures
anxiety assessment
State Trait Inventory Anxiety (STAI Y-A) anxiety assessment questionnaire
Dosimetry
Collection of the dose report produced surface in mGy.cm²
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)
- Cybersickness evaluation
simplified Virtual Reality Sickness Questionnaire (VRSQ) cybersickness scale. (Questionnaire in 9 items)
Full Information
NCT ID
NCT05036772
First Posted
July 5, 2021
Last Updated
June 7, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05036772
Brief Title
Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)
Acronym
Daphné
Official Title
Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salpingography, Virtual Reality Exposure Therapy, Virtual Reality, Pain, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Practice
Arm Type
No Intervention
Arm Description
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
Arm Title
Interventionnal
Arm Type
Experimental
Arm Description
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
Primary Outcome Measure Information:
Title
visual analog scale (EVA)
Description
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?"
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
anxiety assessment
Description
State Trait Inventory Anxiety (STAI Y-A) anxiety assessment questionnaire
Time Frame
through study completion, an average of 1 year
Title
Dosimetry
Description
Collection of the dose report produced surface in mGy.cm²
Time Frame
through study completion, an average of 1 year
Title
Time of exam
Description
Measurement of the time in minutes between the first shot and the last shot (the late evacuation shot will not be taken into account)
Time Frame
through study completion, an average of 1 year
Title
- Cybersickness evaluation
Description
simplified Virtual Reality Sickness Questionnaire (VRSQ) cybersickness scale. (Questionnaire in 9 items)
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume M. DAVY
Phone
033549442942
Email
guillaume.davy@chu-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume DAVY
Phone
033549442942
Email
guillaume.davy@chu-poitiers.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)
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