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

NCT05830513 | Unknown DMC

• 1 other identifier: OPU-LUX
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; IVF

Outcome Measures

Primary Outcomes (1)

• VAS

  visual analogue scale pain scoring

  post OPU (line from 0: no pain to 10:worst pain) immediately post OPU

Secondary Outcomes (5)

• 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)

  Pre-OPU

• vital parameters: pulse rate

  Intraoperative

• vital parameters: blood pressure

  Intraoperative

• vital parameters : oxygen saturation

  Intraoperative

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Device: Virtual Reality

Group B

NO INTERVENTION

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

Interventions

Virtual Reality DEVICE

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.

Group A

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

PD. Dr. med. Kohl Schwartz, Alexandra

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 26, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-03

Locations

CH (1)