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Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)

Sponsor
Poitiers University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05036772
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual reality
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.
Actual Study Start Date :
May 30, 2022
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Practice

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
Experimental: Interventionnal

The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.

Device: Virtual reality
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.

Outcome Measures

Primary Outcome Measures

  1. visual analog scale (EVA) [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?"

Secondary Outcome Measures

  1. anxiety assessment [through study completion, an average of 1 year]

    State Trait Inventory Anxiety (STAI Y-A) anxiety assessment questionnaire

  2. Dosimetry [through study completion, an average of 1 year]

    Collection of the dose report produced surface in mGy.cm²

  3. Time of exam [through study completion, an average of 1 year]

    Measurement of the time in minutes between the first shot and the last shot (the late evacuation shot will not be taken into account)

  4. - Cybersickness evaluation [through study completion, an average of 1 year]

    simplified Virtual Reality Sickness Questionnaire (VRSQ) cybersickness scale. (Questionnaire in 9 items)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire Poitiers France 86000

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT05036772
Other Study ID Numbers:
  • Daphné
First Posted:
Sep 8, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Jun 10, 2022