Virtual Reality Mask During in Utero Surgical Procedures

NCT04917211 | Unknown

• 1 other identifier: APHP201134
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 satisfaction by improving their experience of a risky situation. The therapeutic effects of the virtual reality mask are based on a distractive effect with attentive capture, an emotional effect due to ludic aspect and positive suggestion, and a behavioral effect. In utero fetoscopy is a potentially painful procedure, particularly at the beginning of the procedure due to the introduction of a fetoscopy trocar in the amniotic cavity through the patient's uterus. It also generates anxiety in mothers because of the risks associated with the pathology and the procedure. This research focuses on the use of a virtual reality mask in the reduction of pain and anxiety during in utero surgical procedures. The study is presented and proposed to the patient during the expert ultrasound examination by the obstetrician-gynecologist. Then the modalities are detailed by the anesthetist during the anesthesia consultation before the surgery. The patient is included in the study after the consent is signed. During the anesthesia consultation, the patient is informed of the possibility of analgesia through a virtual reality mask, associated with local anesthesia. It is explained that in case of pain despite the virtual reality mask and local anesthesia, remifentanil administration remains possible. During the anesthesia consultation, the patient's initial state of anxiety is assessed by the score Amsterdam Preoperative Anxiety and Information Scale. The procedure takes place in the theatre room. Upon arrival in the theatre room (preoperative), an evaluation of the anxiety level is performed using a visual analog scale. The virtual reality mask is applied by the anesthesia team before skin disinfection and the placement of sterile drapes. During the procedure, a local anesthesia (non-adrenaline Xylocaine 1%) is performed as usual in order to insert the trocar in the amniotic cavity (diameter 3.5mm) which will be used to introduce the intra-amniotic fetoscope. If during the procedure, the patient feels pain, agitation, pain-related discomfort, morphine analgesia (Intravenous Remifentanil which means Intravenous Anesthesia with Objective Concentration) may be administered by the anesthesia team. Immediately after the procedure, the virtual reality mask will be removed.

Conditions

Fetofetal Transfusion; Analgesia

Keywords

feotoscopy; virtual reality; fetal sugery

Outcome Measures

Primary Outcomes (1)

• the orimary outcome is the success of the virtual reality mask for analgesia defined by the absence of pain expressed by the woman (no administration of morphine (remifentanil)).

  "administration of remifentanil: no=success; yes=failure".

  2 days after the end of intervention

Secondary Outcomes (5)

• Maternal anxiety

  Baseline and immediately after the intervention

• The total dose of remifentanil in microgram (in relation to the total duration of the intervention) in case of administration of remifentanil

  2 days after the end of intervention

• Overall maternal satisfaction

  The satisfaction questionnaire is filled out on day 1 or at the latest on day 2 after intervention

• Side effects

  2 days after the end of intervention

• The rate of patients with a chosen virtual reality theme

  2 days after the end of intervention

Study Arms (1)

virtual reality mask

EXPERIMENTAL

During the prior anesthesia consultation, the patient is informed of the possibility within the framework of the study of benefiting from analgesia with disconnection by a virtual reality mask, associated with local anesthesia. The patient will be explained that in the event of pain despite the virtual reality mask and local anesthesia, administration of remifentanil will be possible

Procedure: Virtual reality mask

Interventions

Virtual reality mask PROCEDURE

"The virtual reality mask is a mask with a screen that is put on the patient's face in the theatre before the surgery. It offers 3D scenarios of about 20 to 40 minutes on five different themes (the Zen garden, the mountain, the forest, the beach, the scuba diving) with music. The video-headset, equipped with head movement sensors, allows the 3D vision of a natural virtual world and the audio-headset emits sounds adapted to the virtual world and music therapy. The RV mask, via multi-sensorial immersion, focuses on two therapeutic targets which are pain and anxiety. It is a non-drug approach ""cousin"" to hypnosis. Its therapeutic effects are based on a distractive effect: attentive capture, an emotional effect: playfulness and positive suggestion, and a behavioral effect: the patient participates and is an actor in his care. "

virtual reality mask

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hannane BOUCHGHOUL

Le Kremlin-Bicêtre, 94270, France

RECRUITING

MeSH Terms

Conditions

Fetofetal Transfusion; Agnosia

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanane BOUCHGHOUL

  Public Assistance of Paris Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanane BOUCHGHOUL

CONTACT

01 45 21 77 80; hanane.bouchghoul@aphp.fr

Marie-Victoire SENAT

CONTACT

01 45 21 77 64; marie-victoire.senat@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: June 8, 2021
• Study Start: October 29, 2022
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

FR (1)