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Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate

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ClinicalTrials.gov Identifier: NCT03064061
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Roelants, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Anxiety in Vitro Fertilization Virtual Reality Device: Virtual reality Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Sham Comparator: Virtual Reality Neutral
neutral VR session before oocytes retrieval
Device: Virtual reality
a device with virtual reality is given to the patients with a film of 18 minutes

Active Comparator: Virtual reality Anxiety
VR session with the goal of reducing anxiety before oocytes retrieval
Device: Virtual reality
a device with virtual reality is given to the patients with a film of 18 minutes




Primary Outcome Measures :
  1. impact of the virtual reality on the pregnancy rate (Ultrasound) [ Time Frame: 12 weeks ]
    measured by ultrasound


Secondary Outcome Measures :
  1. impact of the virtual reality on anxiety (numeric scale) [ Time Frame: immediate ]
    measured with numeric scale (0-10) before and after the VR

  2. impact of the virtual reality on satisfaction [ Time Frame: immediate ]
    measured by a numeric scale 0-10

  3. impact of the virtual reality on pregnancy test [ Time Frame: 6 weeks ]
    measured by blood beta HCG level

  4. state-trait Anxiety Inventory [ Time Frame: immediate ]
    measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064061


Locations
Belgium
Cliniques universitaires Saint-luc Recruiting
Brussels, Belgium, 1200
Contact: Fabienne Roelants, MD    +3227641821    fabienne.roelants@uclouvain.be   
Contact: Célilne Pirard, MD PhD    +3227644112    celine.pirard@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Responsible Party: Roelants, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03064061     History of Changes
Other Study ID Numbers: 2016/20JUL/346
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders