Virtual Reality Mask During in Utero Surgical Procedures

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

Interventions

PROCEDURE

Virtual reality mask

"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. "

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Hanane BOUCHGHOUL · Public Assistance of Paris Hospitals

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-29

Primary Completion

2024-05-01

Completion

2024-12-01

Countries

• France

Study Locations