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

March 20, 2018 updated by: Roelants, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of the virtual reality on the pregnancy rate (Ultrasound)
Time Frame: 12 weeks
measured by ultrasound
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of the virtual reality on anxiety (numeric scale)
Time Frame: immediate
measured with numeric scale (0-10) before and after the VR
immediate
impact of the virtual reality on satisfaction
Time Frame: immediate
measured by a numeric scale 0-10
immediate
impact of the virtual reality on pregnancy test
Time Frame: 6 weeks
measured by blood beta HCG level
6 weeks
state-trait Anxiety Inventory
Time Frame: immediate
measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2017

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/20JUL/346

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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