Analgesia Clinical Trial
— VIRTUALFETOOfficial title:
Use of a Virtual Reality Mask in the Reduction of Pain and Anxiety During in Utero Surgical Procedures
"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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Hannane BOUCHGHOUL | Le Kremlin-Bicêtre |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Maternal anxiety | Anxiety will be assessed by a Visual Analog Scale before and immediately after the intervention (0 being no anxiety and 10 being extremely intense anxiety). An assessment of anxiety using a visual analog scale will be performed before the procedure on arrival in the theatre room and immediately after the procedure after removing the VR mask. This scale provides a score from 0 to 10 to measure the anxiety felt by the patient. This before-after anxiety assessment is used to study the variation in the patient's anxiety between the beginning of the procedure and the end of the procedure. | Baseline and immediately after the intervention | |
Secondary | 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 | ||
Secondary | Overall maternal satisfaction | Evaluation of the experience of the intervention and of maternal satisfaction will be performed using an EVAN-LR questionnaire. The EVAN-LR questionnaire is a validated satisfaction questionnaire for patients who remained conscious during the procedure. One of the strengths of this scale is its applicability in current practice as only 19 items need to be completed by the patient. The average filling time of the EVAN-LR is five minutes. For each item, the patient may check one of the following boxes: Not at all/ A little bit/ Moderately/ A lot/ Very much. | The satisfaction questionnaire is filled out on day 1 or at the latest on day 2 after intervention | |
Secondary | Side effects | nausea, dizziness, headaches, visual disturbances, discomfort | 2 days after the end of intervention | |
Secondary | The rate of patients with a chosen virtual reality theme | 2 days after the end of intervention |
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