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

Not Applicable

Not yet recruiting

• Conditions: IVF; Pain, Postoperative
• Interventions: Device: Virtual Reality

• Registration Number: NCT05830513
• Lead Sponsor: Luzerner Kantonsspital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Study Start: 2023-05
• Primary Completion: 2023-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
VAS	post OPU (line from 0: no pain to 10:worst pain) immediately post OPU	visual analogue scale pain scoring

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PD. Dr. med. Kohl Schwartz, Alexandra; 🇨🇭 Lucerne, Switzerland