Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia

Virtual Reality Clinical Trial

— OVOREV  

Official title:

Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia (OVOREV)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528497
• Other study ID #: 35RC22_8923_OVOREV
• Secondary ID: 2022-A01275-38
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2023
• Source: Rennes University Hospital
• Contact: Tiffany BRUN, MD
• Phone: 02.99. 26.59.11
• Email: Tiffany.BRUN[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Medically Assisted Reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. In the context of In Vitro Fertilization (IVF), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation, followed by an ovarian puncture in order to retrieve mature oocytes. Several types of anesthesia can be used for this procedure: general anesthesia, local anesthesia and spinal anesthesia. The puncture can also be performed under hypnosis, but this practice is difficult to generalize, as it requires specific training. None of these different types of anesthesia has proven to be superior in terms of number and quality of oocytes collected, so the choice is left to the patient. General anesthesia is mostly chosen at Rennes, although it exposes to more risks and represents a higher socio-economic cost. Improving the comfort of these patients during oocyte retrieval is a priority, especially since they may have to undergo several successive retrievals during their treatment. What if virtual reality could be a way to improve the comfort of these patients? Indeed, this technology, which allows activity in an artificial 3-dimensional world, is considered as a non-pharmacological tool for pain management and its use during surgery would also reduce the level of anxiety. In our study, during the oocyte retrieval under local anesthesia, the patients randomized in the experimental group will wear a virtual reality headset diffusing an atmosphere considered as relaxing. The expected results of this work would be a significant decrease in pain during oocyte retrieval under local anesthesia in patients wearing the virtual reality headset, associated with a decrease of anxiety and a significantly higher satisfaction score. The final objective would be to consider this tool as a non-invasive means that could be used in routine in the department of Medically Assisted Reproduction of Rennes, but also in other cities. In the longer term, the reduction of pain and anxiety could encourage patients to choose local anesthesia and therefore increase its use. Observational, prospective, randomized, open-label, monocentric study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female adult (at least 18 years old)
• For whom an oocyte retrieval is planned
• Who has had an anesthesia consultation
• Who has chosen local anesthesia
• Who has signed an informed and written consent
• Affiliated to a social security system.

Exclusion Criteria:

• Pre-existing dizzying sensations
• Severe facial wounds
• History of epilepsy
• Adults under legal protection, curatorship or guardianship, adults deprived of liberty

Related Conditions & MeSH terms

• Local Anaesthesia
• Oocyte Retrieval
• Virtual Reality

Intervention

Other:
• VR+
Use of a virtual reality helmet during ovocyte retrieval

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during oocyte retrieval	The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)	30 minutes
Secondary	Anxiety during oocyte retrieval	The assessment criteria used a numerical scale ranging from 0 to 10 (0 = no anxiety, 10 = extremely anxious).	30 minutes
Secondary	Immediate postoperative pain	The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)	30 minutes
Secondary	The pain felt by the patient during the oocyte retrieval, according to the gynecologist who did the retrieval	The assessment criteria used is the numerical pain scale from 0 to 10 (0 = no pain, 10 = extremely painful)	30 minutes
Secondary	immediate postoperative satisfaction	The assessment criteria used is the Likert scale ranging from 1 (Very dissatisfied) to 5 (Very satisfied)	30 minutes
Secondary	Use of a complementary sedation or a general anesthesia	This criteria will be filled in by the gynecologistby the gynecologist who performed the retrieval: Only local anesthesia; Use of an additional sedation; Switch to general anesthesia	30 minutes