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

NCT05036772 | Completed

• 1 other identifier: Daphné
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Salpingography; Virtual Reality Exposure Therapy; Virtual Reality; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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?"

  through study completion, an average of 1 year

Secondary Outcomes (4)

• anxiety assessment

  through study completion, an average of 1 year

• Dosimetry

  through study completion, an average of 1 year

• Time of exam

  through study completion, an average of 1 year

• - Cybersickness evaluation

  through study completion, an average of 1 year

Study Arms (2)

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.

Device: Virtual reality

Interventions

Virtual reality DEVICE

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

Interventionnal

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: September 8, 2021
• Study Start: May 30, 2022
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)