Status:

UNKNOWN

Virtual Reality Mask During in Utero Surgical Procedures

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Fetofetal Transfusion

Analgesia

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

"The virtual reality mask is an innovative technique, alternative to pharmacological medicine that would allow, in addition to its action on pain, to reduce anxiety and thus increase patient satisfact...

Detailed Description

"The use of the virtual reality mask associated with local anesthesia during in utero fetal surgery procedures by fetoscopy in the treatment of complications of monochorionic twin pregnancies, could b...

Eligibility Criteria

Inclusion

  • Aged more than 18 years old
  • Complicated biamniotic monochorionic twin pregnancy
  • Indication for fetal surgery: Fetoscopy laser photocoagulation or Selective termination of pregnancy.
  • Patient Consent
  • Affiliation to a social security coverage

Exclusion

  • No understanding of the French language
  • Visually impaired or hard of hearing
  • Participation in another intervention research
  • Patient under State medical aid
  • Psychiatric disorders (schizophrenia, schizophreniform disorders)
  • Major neurocognitive disorders (dementias)
  • Migraine helped a basic treatment
  • Epilepsy with treatment
  • Pacemaker carrier
  • With lesions on the scalp

Key Trial Info

Start Date :

October 29 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT04917211

Start Date

October 29 2022

End Date

December 1 2024

Last Update

December 28 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hannane BOUCHGHOUL

Le Kremlin-Bicêtre, France, 94270