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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; IVF
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lucerne, Switzerland, 6000
    • PD. Dr. med. Kohl Schwartz, Alexandra
    • Contact: Angela Vidal
    • Contact: Lea Schumpf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Women will be randomly allocated to undergo OPU either with the use of Virtual reality(group A)	Device: Virtual Reality; 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.
No Intervention: Group B; Women will be randomly assigned to an OPU in the control group with standard treatment, withouth analgesia (Group B).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: OPU-LUX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No