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Completed

NCT Number: NCT07190729

Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ICSI Oocyte Retrieval

Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed, with the aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.

Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.

However, to date, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published. Our study will evaluate if using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, PARIS, 75020, France

About this study

Over the last few years, audiovisual distraction devices using animation, films and 3D immersion have been developed. These devices aim to provide patients with a relaxing experience that disconnects them from the operating environment while still allowing them to interact with the surgeon. These devices make it easier for surgeons to perform short procedures and improve patients' experiences.

Virtual distraction techniques have been evaluated in several areas, particularly in managing preoperative pain and anxiety in adults.

However, no study comparing different techniques for focusing attention and the anaesthetic management of oocyte punctures has been published to date. This study hypothesises that using the Deepsen™ mask device to focus attention in a virtual reality environment is more effective than the usual verbal reassurance technique at reducing anxiety levels and sedation requirements during oocyte punctures, while improving comfort and enabling faster walking.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 and under 43 years of age.
  • Requiring propofol sedation for oocyte puncture.
  • Who can be contacted directly by telephone the day after the procedure.
  • Have given their consent to participate in accordance with the regulations.
  • Benfeting of a social security scheme or entitled persons (excluding AME).

Exclusion criteria

  • Active endometriosis.
  • Presence of at least one anatomically high ovary which is difficult to puncture.
  • Inability to understand the information provided.
  • Under guardianship, curatorship or legal protection.
  • Under psychiatric care.
  • Admitted to a health or social establishment for purposes other than this research.
  • Under constraint or deprived of liberty by judicial or administrative decision.
  • Impaired communication or neuropsychological disorders.
  • Ongoing corneal or conjunctival pathologies.
  • Claustrophobia.
  • Nausea in the mountains or at sea.
  • Use of an anxiolytic or sleeping pill in the 12 hours prior to randomisation.

Treatment and study plan

Propofol sedation + Audiovisual distraction

Device

The participants will receive standard propofol sedation procedure and the mask -RV Deepsen™

Propofol sedation

Other

The participants will receive standard propofol sedation procedure

Primary outcomes

  1. The Cp50 value of propofol in each group.

    Time frame: Day 0

    The Cp50 is defined as the median of the target concentration at which 50% of participants showed movement during the oocyte puncture procedure. Any difference between the two groups will be determined using Dixon's up and down technique

  2. The number and proportion of participants not requiring sedation

    Time frame: Day 0

Secondary outcomes

  1. Effect on procedural anxiety

    Time frame: Day 0

    The participant's anxiety was measured prior to the study. It was assessed using the STAI questionnaire in order to define the general state of anxiety (STRAI) and the level of immediate anxiety in relation to the examination (STATE). This is a two-part questionnaire with around thirty questions in each section, for which a single response is used to describe the intensity of the relationship: very often, often, rarely, never. An anxiety VAS will be requested at the time of the WHO checklist, together with the intensity of any pain. These questions will be asked again in the intensive care unit when the patient is put in the standing position.

  2. Tolerating audiovisual distraction

    Time frame: 48 hours

    Tolerance of the device and the audiovisual distraction session is defined by the occurrence of undesirable effects (dizziness, nausea, headaches). This is done using a 4-level scale for each item (none, mild, moderate, severe).

  3. Pain on injection of propofol

    Time frame: Day 0

    The intensity of pain on propofol injection was assessed using a three-point behavioural scale for facial expression (0: none, 1: frown, or 2: grimace), verbal response (0: none, 1: groan, or 2: clear expression of pain) and attempt to withdraw the arm (0: none, 1: medium, or 2: strong). The discomfort scale is the sum of these three clinical parameters and therefore ranges from 0 to 6.

  4. Complications observed during anaesthesia

    Time frame: Day 0

    Any complications linked to anaesthesia from induction to recovery are collected:

    • Number of events with arterial oxygen desaturation below 92%,
    • Number of episodes with a ventilatory frequency of less than 10 cycles/min,
    • Occurrence of bronchospasm.
  5. The time required to walk

    Time frame: Day 0

    Time to street readiness will be assessed using the CHUNG

  6. Acceptance of audiovisual distraction by anaesthetists, gynaecologists and other healthcare professionals

    Time frame: Day 0

    Acceptance of audiovisual distraction by anaesthetists, gynaecologists and nursers will be assessed using a 4-level scale (very satisfied, satisfied, partially satisfied, not satisfied) and by collecting reasons for not being satisfied (partially satisfied, not satisfied) (short open answers).

  7. Participant satisfaction with the procedure

    Time frame: Day 0

    Participant satisfaction is assessed on leaving the post-interventional monitoring room using a 4-level scale (very satisfied, satisfied, partially satisfied, not satisfied), with a free text provided in addition. Any interruption of the audiovisual distraction session at the participant's request will be noted. Satisfaction with the procedure may also be obtained from healthcare professionals.

  8. Resumption of activities of daily living

    Time frame: Day 1

    Resumption of activities of daily living was assessed during the next day's telephone call using a subjective numerical rating scale ranging from 0 (bedridden) to 10 (full recovery).

  9. Recovery room discharge time

    Time frame: Day 0

    Post-intervention monitoring room discharge time is defined as the time between the end of the operation and the achievement of an ALDRETE score of 10.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Acronym: REVAHPOVO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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