Adverse Events, Medication Administration, Oocyte Retrieval, Pain Intensity, Procedural Anxiety, Satisfaction
Conditions
Keywords
Virtual Reality, Oocyte Retrieval, In Vitro Fertilization, Randomized Control Trial
Brief summary
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.
Detailed description
Background / Rationale 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. Psycho-social factors such as anxiety, previous negative experiences with gynecological examinations, and perceived lack of control are important predictors of OR-related pain. This finding is consistent with the multidimensionality of the pain experience. Although several adjuvant therapies have been proposed to reduce psychological stress during ART (assisted reproductive technology) therapy, their impact on the OR experience has been mixed. Virtual reality (VR) allows users to engage in a fully immersive simulated environment using an advanced visual and auditory system. Multimodal stimuli contribute to a sense of actual presence/immersion in the virtual world, thus making the VR experience distinct from passive visual or auditory stimuli. The utility of VR therapy has been explored for numerous health applications, showing positive outcomes in clinical conditions such as dental procedures, burn wound care, colonoscopy, as well as other minor procedures. A recent systematic review of 39 RCTs (randomized clinical trials) concluded that VR's immersive, entertaining effects are useful for redirecting a patient's attention away from painful treatment experiences and reducing anxiety, discomfort, and unpleasantness. Several studies have shown a significant decrease in pain perception and anxiety scores when treated with VR, as measured by anxiety questionnaires, pulse rate reduction, and electroencephalogram changes compared with controls. To the best of our knowledge, there are no published studies that examine the application of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval. Purpose The primary objectives of this pilot study are to evaluate patient acceptance, perceived utility, and adverse effects of VR technology during the oocyte retrieval procedure as measured by validated VR-engagement and anxiety-related questionnaires
Interventions
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
Sponsors
Study design
Intervention model description
This will be a randomized, single-blinded, two-arm pilot study. Due to the nature of the intervention, participants cannot be blinded to allocation, but the physician performing the oocyte retrieval will be blinded to minimize the risk of bias.
Eligibility
Inclusion criteria
\- All adults undergoing their first oocyte retrieval
Exclusion criteria
* severe visual impairment * contraindications to using VR technology according to manufacturer specifications including: * severe motion sickness * epilepsy/previous seizure * claustrophobia * current migraine * heart disease * use of medical devices such as cardiac pacemaker or hearing aids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment satisfaction and immersion | 10 minutes | measured by the IGroup Presence Questionnaire (IPQ) -Scaled 14-item questionnaire administered post-OR |
| Adverse events | 20 minutes | measured by the Simulator Sickness Questionnaire (SSQ) - Scaled 16-itemquestionnaire administered pre-OR and post-OR. |
| Procedural anxiety | 20 minutes | measured by the State-Trait Anxiety Inventory (STAI) Questionnaire -Scaled 20-item questionnaire administered at recruitment, pre-OR, and post-OR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of oocytes retrieved / peak E2 | 20 minutes | — |
| Pain intensity | 10 minutes | using the Numerical Rating Scale (20) |
| Total number of MII oocytes retrieved / number of follicles ≥ 17mm on day of trigger | 20 minutes | — |
| Total opioid and benzodiazepine use | 20 minutes | Dose for the procedure |
| Duration of procedure | 20 minutes | — |