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

Sponsor

Luzerner Kantonsspital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05830513

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative IVF	Device: Virtual Reality	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

VAS [post OPU (line from 0: no pain to 10:worst pain) immediately post OPU]
visual analogue scale pain scoring

Secondary Outcome Measures

VAS for anxiety [Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU]
VAS for anxiety
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: blood pressure [Intraoperative]
vital parameters: blood pressure (systolic and diastolic pressures)
vital parameters : oxygen saturation [Intraoperative]
vital parameters : oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PD. Dr. med. Kohl Schwartz, Alexandra	Lucerne		Switzerland	6000

Sponsors and Collaborators

Luzerner Kantonsspital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luzerner Kantonsspital

ClinicalTrials.gov Identifier:

NCT05830513

Other Study ID Numbers:

OPU-LUX

First Posted:

Apr 26, 2023

Last Update Posted:

Apr 26, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Apr 26, 2023