search
Back to results

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

Primary Purpose

Pain, Postoperative, IVF

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Luzerner Kantonsspital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • PD. Dr. med. Kohl Schwartz, Alexandra

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

VAS
visual analogue scale pain scoring

Secondary Outcome Measures

VAS for anxiety
VAS for anxiety
state-trait anxiety inventory form (STAI)
state-trait anxiety inventory form (STAI)
vital parameters: pulse rate
vital parameters : pulse rate
vital parameters: blood pressure
vital parameters: blood pressure (systolic and diastolic pressures)
vital parameters : oxygen saturation
vital parameters : oxygen saturation

Full Information

First Posted
March 14, 2023
Last Updated
April 24, 2023
Sponsor
Luzerner Kantonsspital
search

1. Study Identification

Unique Protocol Identification Number
NCT05830513
Brief Title
OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up
Acronym
OPU-LUX
Official Title
OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luzerner Kantonsspital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, IVF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Women will be randomly allocated to undergo OPU either with the use of Virtual reality(group A)
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Women will be randomly assigned to an OPU in the control group with standard treatment, withouth analgesia (Group B).
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
VAS
Description
visual analogue scale pain scoring
Time Frame
post OPU (line from 0: no pain to 10:worst pain) immediately post OPU
Secondary Outcome Measure Information:
Title
VAS for anxiety
Description
VAS for anxiety
Time Frame
Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU
Title
state-trait anxiety inventory form (STAI)
Description
state-trait anxiety inventory form (STAI)
Time Frame
Pre-OPU
Title
vital parameters: pulse rate
Description
vital parameters : pulse rate
Time Frame
Intraoperative
Title
vital parameters: blood pressure
Description
vital parameters: blood pressure (systolic and diastolic pressures)
Time Frame
Intraoperative
Title
vital parameters : oxygen saturation
Description
vital parameters : oxygen saturation
Time Frame
Intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
PD. Dr. med. Kohl Schwartz, Alexandra
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Vidal
First Name & Middle Initial & Last Name & Degree
Lea Schumpf

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs