NCT05567315

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

February 24, 2022

Last Update Submit

December 8, 2023

Conditions

Oocyte Retrieval

Outcome Measures

Primary Outcomes (1)

  • Analgesia Nociception Index (ANI) measurement

    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

    during oocyte puncture procedure

Secondary Outcomes (8)

  • Anxiety with beck anxiety inventory

    1 hour before intervention and immediately after the intervention

  • Simulator Sickness Questionnaire (SSQ)

    Immediately after the intervention

  • Analog visual scale (AVS)

    Immediately after the intervention

  • Post intervention analgesic therapy

    Immediately after the intervention

  • Total duration of the procedure of oocyte ponction (min)

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

  • +3 more secondary outcomes

Study Arms (2)

Oocyte puncture with local anaesthesia alone

ACTIVE COMPARATOR
Drug: local anaesthetic injection

Oocyte puncture with local anaesthesia and additional virtual reality hypnosis

EXPERIMENTAL
Drug: local anaesthetic injectionDevice: hypnosis with Virtual reality mask

Interventions

local anaesthetic injectionDRUG

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)

Oocyte puncture with local anaesthesia aloneOocyte puncture with local anaesthesia and additional virtual reality hypnosis
hypnosis with Virtual reality maskDEVICE

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

Oocyte puncture with local anaesthesia and additional virtual reality hypnosis

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique mutualiste La Sagesse

Rennes, Brittany Region, 35043, France

Location

MeSH Terms

Interventions

Anesthesia, LocalHypnosis

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The person collecting the endpoints will be blinded to the treatment group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single-centre, comparative, randomised, parallel group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

February 24, 2022

First Posted

October 5, 2022

Study Start

October 11, 2022

Primary Completion

May 26, 2023

Study Completion

May 26, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations

FR(1)