Oocyte RetrievalHypnoPONCT05567315
Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure
A study testing local anaesthetic injection and hypnosis with Virtual reality mask in people with Oocyte Retrieval, run by Clinique Mutualiste la Sagesse at 1 site in France.
Trial summary
Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Oocyte Retrieval
- What is being tested?
- local anaesthetic injection and hypnosis with Virtual reality mask
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2022to 26 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure: a Randomised Controlled Study
Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture
- Conditions
- Oocyte Retrieval
- Being tested
- local anaesthetic injection, hypnosis with Virtual reality mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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
| Study group | Role | What they receive |
|---|---|---|
| Oocyte puncture with local anaesthesia alone | Active comparator | Not described Receives: Drug: local anaesthetic injection |
| Oocyte puncture with local anaesthesia and additional virtual reality hypnosis | Experimental | Not described Receives: Drug: local anaesthetic injection; Device: hypnosis with Virtual reality mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during oocyte puncture procedure
Secondary outcomes (8)
Anxiety with beck anxiety inventory
Measurement of anxiety by the Beck Anxiety Inventory, on admission to hospital and on return to the ward, 1 hour after the oocyte puncture
Measured: 1 hour before intervention and immediately after the intervention
Simulator Sickness Questionnaire (SSQ)
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.
Measured: Immediately after the intervention
Analog visual scale (AVS)
Pain evaluation with Analog visual scale by the patient himself from 0 to 10, a higher score mean a worse outcome.
Measured: Immediately after the intervention
Post intervention analgesic therapy
Identify the need for postoperative analgesic treatment in the two groups
Measured: Immediately after the intervention
Total duration of the procedure of oocyte ponction (min)
Total duration of the procedure (min), from the beginning of local anesthesia to the end of the oocyte retrieval
Measured: From the first ponction of local anesthesia to the end of the retrieval of the last oocyte
Conversion rate from local anaesthesia to unplanned general anaesthesia
Conversion rate in percent
Measured: Immediately after the intervention
Gynecologist's numerical satisfaction scale
Measure by a numerical scale out of 10, a higher score mean a better outcome.
Measured: Immediately after the intervention
Patient's numerical satisfaction scale
Measure by a numerical scale out of 10, a higher score mean a better outcome.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start11 Oct 2022
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte RetrievalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre, comparative, randomised, parallel group study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Mutualiste la Sagesse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Denoual, Clinique Mutualiste la Sagesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567315
- Sponsor's protocol ID
- 2021-A02136-35
- Acronym
- HypnoPO
- Status last verified
- Dec 2023
- First submitted
- 24 Feb 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05567315
- Acronym / sponsor ID
- HypnoPO / 2021-A02136-35
- Conditions
- Oocyte Retrieval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Clinique Mutualiste la SagesseUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre, comparative, randomised, parallel group study
| Arm | Type | Receives |
|---|---|---|
| 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 injection, Device: hypnosis with Virtual reality mask |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anaesthetic injectionInfiltration 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) | Drug | Oocyte puncture with local anaesthesia alone, Oocyte puncture with local anaesthesia and additional virtual reality hypnosis |
| hypnosis with Virtual reality maskA 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 | Device | Oocyte puncture with local anaesthesia and additional virtual reality hypnosis |
Primary outcome
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
8 secondary outcomes
Anxiety with beck anxiety inventory
Time frame: 1 hour before intervention and immediately after the intervention
Simulator Sickness Questionnaire (SSQ)
Time frame: Immediately after the intervention
Analog visual scale (AVS)
Time frame: Immediately after the intervention
Post intervention analgesic therapy
Time frame: Immediately after the intervention
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
Conversion rate from local anaesthesia to unplanned general anaesthesia
Time frame: Immediately after the intervention
Gynecologist's numerical satisfaction scale
Time frame: Immediately after the intervention
Patient's numerical satisfaction scale
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anaesthetic injection and hypnosis with Virtual reality mask in people with Oocyte Retrieval, run by Clinique Mutualiste la Sagesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia Nociception Index (ANI) measurement (time frame: during oocyte puncture procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.