Back to resultsImpact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate
Primary Purpose
Anxiety, in Vitro Fertilization, Virtual Reality
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.
- Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)
Exclusion Criteria:
- Patients with long-term psychotherapeutic treatment
- Patients taking psychotropic drugs
- patient blind and deaf
Sites / Locations
- Cliniques universitaires Saint-lucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Virtual Reality Neutral
Virtual reality Anxiety
Arm Description
neutral VR session before oocytes retrieval
VR session with the goal of reducing anxiety before oocytes retrieval
Outcomes
Primary Outcome Measures
impact of the virtual reality on the pregnancy rate (Ultrasound)
measured by ultrasound
Secondary Outcome Measures
impact of the virtual reality on anxiety (numeric scale)
measured with numeric scale (0-10) before and after the VR
impact of the virtual reality on satisfaction
measured by a numeric scale 0-10
impact of the virtual reality on pregnancy test
measured by blood beta HCG level
state-trait Anxiety Inventory
measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital
Full Information
NCT ID
NCT03064061
First Posted
December 26, 2016
Last Updated
March 20, 2018
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03064061
Brief Title
Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate
Official Title
Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, in Vitro Fertilization, Virtual Reality
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Neutral
Arm Type
Sham Comparator
Arm Description
neutral VR session before oocytes retrieval
Arm Title
Virtual reality Anxiety
Arm Type
Active Comparator
Arm Description
VR session with the goal of reducing anxiety before oocytes retrieval
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
a device with virtual reality is given to the patients with a film of 18 minutes
Primary Outcome Measure Information:
Title
impact of the virtual reality on the pregnancy rate (Ultrasound)
Description
measured by ultrasound
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
impact of the virtual reality on anxiety (numeric scale)
Description
measured with numeric scale (0-10) before and after the VR
Time Frame
immediate
Title
impact of the virtual reality on satisfaction
Description
measured by a numeric scale 0-10
Time Frame
immediate
Title
impact of the virtual reality on pregnancy test
Description
measured by blood beta HCG level
Time Frame
6 weeks
Title
state-trait Anxiety Inventory
Description
measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital
Time Frame
immediate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.
Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)
Exclusion Criteria:
Patients with long-term psychotherapeutic treatment
Patients taking psychotropic drugs
patient blind and deaf
Facility Information:
Facility Name
Cliniques universitaires Saint-luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne Roelants, MD
Phone
+3227641821
Email
fabienne.roelants@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Célilne Pirard, MD PhD
Phone
+3227644112
Email
celine.pirard@uclouvain.be
12. IPD Sharing Statement
Learn more about this trial
Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate
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