Health TrialsbyHealthPanel

The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization

ConditionsOocyte RetrievalAdverse EventsProcedural AnxietyPain IntensitySatisfactionMedication Administration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-43
SponsorMount Sinai Hospital, Canada

About this trial

Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Adjuvant virtual reality (VR) therapy has been explored to reduce psychological stress during dental procedures, burn wound care, colonoscopy, as well as other minor procedures. Hence, the purpose of this study is to evaluate the use of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

severe visual impairment

severe motion sickness

epilepsy/previous seizure

claustrophobia

Trial design

Design model

Parallel

Treatments tested in this trial

  • VR-based intervention (VRReliever Software V0.3.4 fromXRHealth)

    Device

    The participant will be able to select between four VR environments: beach, lake, forest, or mountain scenery. Each provides an immersive audio and visual environment designed to reduce anxiety and promote relaxation. Each scene is rendered in a high-resolution and life-like fashion which participants can experience in a full 360 degrees. Participants will wear the headset for the duration of the egg retrieval procedure which is approximately 15-20 minutes.

  • VR headset without any scenery

    Device

    VR headset without any scenery

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment satisfaction and immersion

measured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR

Time frame
10 minutes
2

Adverse events

measured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR.

Time frame
20 minutes
3

Procedural anxiety

measured by the State-Trait Anxiety Inventory (STAI) Questionnaire -Scaled 20-item questionnaire administered at recruitment, pre-OR, and post-OR.

Time frame
20 minutes

Secondary outcomes

1

Pain intensity

using the Numerical Rating Scale (20)

Time frame
10 minutes
2

Total opioid and benzodiazepine use

Dose for the procedure

Time frame
20 minutes
3

Duration of procedure

Time frame
20 minutes
4

Total number of oocytes retrieved / peak E2

Time frame
20 minutes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mount Sinai Hospital, Canada

Lead sponsor

University of Toronto

Sponsor institution

Reproductive Endocrinology and Infertility

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: