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

NCT05528497 | Unknown

• 2 other identifiers: 35RC22_8923_OVOREV2022-A01275-38
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Oocyte Retrieval; Local anaesthesia; Virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Anxiety during oocyte retrieval

  30 minutes

• Immediate postoperative pain

  30 minutes

• The pain felt by the patient during the oocyte retrieval, according to the gynecologist who did the retrieval

  30 minutes

• immediate postoperative satisfaction

  30 minutes

• Use of a complementary sedation or a general anesthesia

  30 minutes

Study Arms (2)

VR+

EXPERIMENTAL

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

Other: VR+

Control

NO INTERVENTION

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

Interventions

VR+ OTHER

Use of a virtual reality helmet during ovocyte retrieval

VR+

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female Reproductive Cell Retrieval
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

RECRUITING

Central Study Contacts

Tiffany BRUN, MD

CONTACT

02.99. 26.59.11; Tiffany.BRUN@chu-rennes.fr

Kristell Coat

CONTACT

0299282555; Kristell.coat@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: September 26, 2022
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

FR (1)