Virtual Reality Hypnosis as Sedation During Oocyte Retrieval: Effect on Propofol Consumption

Официальное название

Virtual Reality Hypnosis as Sedation During Oocyte Retrieval: Effect on Propofol Consumption: a Randomized Study (VRH-IVF)

Обзор

An egg retrieval is performed during an IVF course. This painful procedure is performed using sedation to ensure patient comfort. A combination of sedative and analgesic medications combined with local anesthesia (paracervical block) is used. Propofol, the intravenous anesthetic of choice (rapid-acting and short-acting), and remifentanil (an ultra-short-acting opioid analgesic) are generally combined. The potential impact of these agents used for egg retrieval on egg fertilization and embryo quality is of interest. Indeed, certain drugs such as propofol could accumulate in the follicular fluid. The few studies conducted to date show contradictory results. While a harmful effect appears to be reported in experimental studies on mice, this effect is uncertain in clinical studies. Given this uncertainty, any method aimed at reducing propofol consumption in this context may be of interest. Virtual reality hypnosis (VRH) is a digital tool that has already been shown to be effective in reducing preoperative anxiety during oocyte retrieval. Furthermore, VRH has also demonstrated analgesic effects. The primary objective of this study is to compare VRH with a control group (usual sedation) on propofol consumption during oocyte retrieval. Secondary objectives are to compare preoperative anxiety, APAIS score, catastrophizing score, remifentanil consumption, intra- and/or post-operative nausea and vomiting, post-procedural analgesic consumption, time perception during the procedure, fertilization parameters, and pregnancy rate at 12 weeks. The degrees of absorption, dissociation, immersion, and presence for the VRH group will also be noted.

Подробное описание

This is a prospective, single-center, randomized, controlled interventional study that will include 72 patients. Patients will be randomized into two groups: a Control group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) during the retrieval, and an RVH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety. To be included, patients must have undergone egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc, be French-speaking, have undergone simple IVF or ICSI IVF, and must not be undergoing long-term psychotherapeutic treatment or taking psychotropic medications. They must also have given their free, informed and written consent signed by the investigator and the patient in the days preceding the intervention. Patients with morbid obesity, blindness and/or deafness and with a history contraindicating the use of anti-inflammatory drugs will be excluded from the study.

Вмешательства

• Другое virtual reality hypnosis device
  VRH group, in which patients will receive conventional sedation (remifentanil 0.1 mcg/kg/min and propofol 0.5 mg/kg if necessary) and a Virtual Reality headset with an environment chosen by the patient and hypnosis support with suggestions to reduce their anxiety.

Первичные конечные точки

• The primary outcome of this study is to compare VRH with a control group (usual sedation) on propofol consumption during the procedure. [Срок оценки: Day 0]

Критерии участия

Критерии включения

• egg retrieval as part of their IVF at the Cliniques universitaires Saint-Luc,
• to be French-speaking,
• simple IVF or ICSI IVF
• 18-42 yrs

Критерии исключения

• morbid obesity
• blindness and/or deafness
• history contraindicating the use of anti-inflammatory drugs
• long-term psychotherapeutic treatment or taking psychotropic medications.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Rousseaux F, Panda R, Toussaint C, Bicego A, Niimi M, Faymonville ME, Nyssen AS, Laureys S, Gosseries O, Vanhaudenhuyse A. Virtual reality hypnosis in the management of pain: Self-reported and neurophysiological measures in healthy subjects. Eur J Pain. 2023 Jan;27(1):148-162. doi: 10.1002/ejp.2045. Epub 2022 Oct 24. PMID 36196745
• Pirard C, Laurent P, Wyns C, Giudice MG, Watremez C, Momeni M, Roelants F. Impact of virtual reality with or without hypnosis before oocyte retrieval: A randomised study. Complement Ther Med. 2025 Mar;88:103125. doi: 10.1016/j.ctim.2024.103125. Epub 2025 Jan 3. PMID 39756588
• Matsota P, Sidiropoulou T, Vrantza T, Boutsikou M, Midvighi E, Siristatidis C. Comparison of Two Different Sedation Protocols during Transvaginal Oocyte Retrieval: Effects on Propofol Consumption and IVF Outcome: A Prospective Cohort Study. J Clin Med. 2021 Mar 1;10(5):963. doi: 10.3390/jcm10050963. PMID 33804575

Идентификаторы

NCT: NCT07104409 · 2025/24JUI/253 · VRH-IVF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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