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

Luzerner Kantonsspital

Status: Not yet enrolling

Conditions: IVF; Pain, Postoperative

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05830513

OPU-LUX

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A

Active Comparator group

Description:

Women will be randomly allocated to undergo OPU either with the use of Virtual reality(group A)

Treatment:

Device: Virtual Reality

Group B

No Intervention group

Description:

Women will be randomly assigned to an OPU in the control group with standard treatment, withouth analgesia (Group B).