OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up

Study Overview
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Brief Summary
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In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Mostly of the women reported experiencing mild to moderate pain when undergoing OPU without anesthesia. Nevertheless, there is a need for alternative pain treatment options during OPU to reduce the burden of IVF for patients. Virtual reality (VR) may have a role in acutely painful procedures as a non-pharmacological alternative. VR refers to the interactions between an individual and a computer-generated environment stimulating multiple sensory modalities. The immersive, entertaining effects of VR could be useful for redirecting the patient's attention away from painful treatment experiences and reducing anxiety, discomfort, or unpleasantness. Use of VR interventions has been studies in a wider range of medical treatment.

Official Title
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OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up - a Randomized Controlled Trial

Conditions
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Pain, Postoperative, IVF

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 43 years IVF with follicular aspiration of one to tree follicles Written informed consent signed by the participant must be obtained prior to OPU Exclusion Criteria: OPU with more than tree follicular aspiration Individuals' anatomy complicating the intervention (e. g. endometriosis stage III/IV) Application of analgesics within eight hours before OPU hearing impairments migraines seizure disorder vestibular abnormalities history of motion sickness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Women will be randomly allocated to undergo OPU either with the use of Virtual reality(group A) | Device: Virtual Reality<br>* Women will be randomly allocated to undergo OPU either with the use of virutal reality (group A) or the control group with standard treatment, without analgesia(group B). The participants of group A will wear the Oculus Quest 2 and will be surrounded by a virtual world. They will see objects flying towards themselves. They will be able to interact with the virtual world by hand controllers and can try to catch the objects.<br>|
| No Intervention: Group B<br>Women will be randomly assigned to an OPU in the control group with standard treatment, withouth analgesia (Group B). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | visual analogue scale pain scoring | post OPU (line from 0: no pain to 10:worst pain) immediately post OPU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for anxiety | VAS for anxiety | Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU | 
| state-trait anxiety inventory form (STAI) | state-trait anxiety inventory form (STAI) | Pre-OPU | 
| vital parameters: pulse rate | vital parameters : pulse rate | Intraoperative | 
| vital parameters: blood pressure | vital parameters: blood pressure (systolic and diastolic pressures) | Intraoperative | 
| vital parameters : oxygen saturation | vital parameters : oxygen saturation | Intraoperative |