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

Pain, Postoperative Clinical Trial

— OPU-LUX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830513
• Other study ID #: OPU-LUX
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2023
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• IVF
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Switzerland	PD. Dr. med. Kohl Schwartz, Alexandra	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	visual analogue scale pain scoring	post OPU (line from 0: no pain to 10:worst pain) immediately post OPU
Secondary	VAS for anxiety	VAS for anxiety	Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU
Secondary	state-trait anxiety inventory form (STAI)	state-trait anxiety inventory form (STAI)	Pre-OPU
Secondary	vital parameters: pulse rate	vital parameters : pulse rate	Intraoperative
Secondary	vital parameters: blood pressure	vital parameters: blood pressure (systolic and diastolic pressures)	Intraoperative
Secondary	vital parameters : oxygen saturation	vital parameters : oxygen saturation	Intraoperative