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Completed

NCT Number: NCT05567315

Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure

Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture

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Key information

Conditions

Oocyte Retrieval

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique mutualiste La Sagesse

Rennes, Brittany Region, 35043, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient having an oocyte puncture as part of a medically assisted procreation procedure
  • Surgical procedure planned in the operating theatre under local anaesthesia at the Clinique Mutualiste La Sagesse
  • Patient capable of receiving and understanding information about the study and giving written informed consent.
  • Affiliated to a social security system

Exclusion criteria

  • Patient's refusal to participate in a study
  • Patient having an oocyte retrieval as part of an oocyte donation
  • Unbalanced epilepsy.
  • Hearing and/or visual impairments that contraindicate the use of the virtual reality headset.
  • Patient with a poor understanding of the French language.
  • Medical indication to carry out the oocyte puncture under general anaesthesia
  • Drug allergy or hypersensitivity to PARACETAMOL - IBUPROFEN or NEFOPAM prescribed during the pre-medication.
  • Patient under legal protection

Treatment and study plan

local anaesthetic injection

Drug

Infiltration of 40 to 80 ml of a non-adrenalized 0.5% lidocaine solution into the vaginal wall at the level of the vaginal pouches, under ultrasound guidance. (within the limit of the toxic doses, i.e. 5mg/kg)

hypnosis with Virtual reality mask

Device

A 20-minute virtual reality hypnosis session is performed from the time the patient is placed on the surgical table until the end of the oocyte poncture

Primary outcomes

  1. Analgesia Nociception Index (ANI) measurement

    Time frame: during oocyte puncture procedure

    The level of pain perceived by the patient during the performance of a painful care procedure will be measured by the ANI index which reflects heart rate variability

Secondary outcomes

  1. Anxiety with beck anxiety inventory

    Time frame: 1 hour before intervention and immediately after the intervention

    Measurement of anxiety by the Beck Anxiety Inventory, on admission to hospital and on return to the ward, 1 hour after the oocyte puncture

  2. Simulator Sickness Questionnaire (SSQ)

    Time frame: Immediately after the intervention

    Assessment of tolerance of virtual reality with SSQ ; SSQ is a scale of cyber sickness from 0 to 48, a higher score mean a worse outcome.

  3. Analog visual scale (AVS)

    Time frame: Immediately after the intervention

    Pain evaluation with Analog visual scale by the patient himself from 0 to 10, a higher score mean a worse outcome.

  4. Post intervention analgesic therapy

    Time frame: Immediately after the intervention

    Identify the need for postoperative analgesic treatment in the two groups

  5. Total duration of the procedure of oocyte ponction (min)

    Time frame: From the first ponction of local anesthesia to the end of the retrieval of the last oocyte

    Total duration of the procedure (min), from the beginning of local anesthesia to the end of the oocyte retrieval

  6. Conversion rate from local anaesthesia to unplanned general anaesthesia

    Time frame: Immediately after the intervention

    Conversion rate in percent

  7. Gynecologist's numerical satisfaction scale

    Time frame: Immediately after the intervention

    Measure by a numerical scale out of 10, a higher score mean a better outcome.

  8. Patient's numerical satisfaction scale

    Time frame: Immediately after the intervention

    Measure by a numerical scale out of 10, a higher score mean a better outcome.

Sponsors and collaborators

Lead sponsor

Clinique Mutualiste la Sagesse

Other

Registry information

Official study title

Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure: a Randomised Controlled Study

Acronym: HypnoPO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2022
Registry last updated
Dec 11, 2023

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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