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

NCT ID: NCT05528497

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2024-05-01

Brief 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.

Conditions

Oocyte Retrieval; Local Anaesthesia; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VR+

For patients in the experimental group, using the virtual reality headset, the caregiver will place the headset on the patient as she is laid on the surgical table. The caregiver will ensure that the patient can see and hear the sequence that is being performed. The caregiver can then proceed to the different stages of ovocyte retrieval. Once the procedure is finished, the caregiver tells the patient that she can remove the headset

Group Type: EXPERIMENTAL

VR+

Intervention Type: OTHER

Use of a virtual reality helmet during ovocyte retrieval

Control

For patients in the control group, without a headset, the oocyte retrieval procedure will not be modified.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VR+

Use of a virtual reality helmet during ovocyte retrieval

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rennes University Hospital

Rennes, Brittany Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Tiffany BRUN, MD

Role: CONTACT

Tiffany.BRUN@chu-rennes.fr

02.99. 26.59.11 ext. 33

Kristell Coat

Role: CONTACT

Kristell.coat@chu-rennes.fr

0299282555 ext. 33

Facility Contacts

Tiffany BRUN, MD

Role: primary

Tiffany.BRUN@chu-rennes.fr

02.99.28.43.21 ext. 33

Sophia DIFADI

Role: backup

sophia.difadi@gmail.com

Other Identifiers

2022-A01275-38

Identifier Type: OTHER

Identifier Source: secondary_id

35RC22_8923_OVOREV

Identifier Type: -

Identifier Source: org_study_id