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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Unknown status
CT.gov ID
NCT03064061
Collaborator
(none)
600
Enrollment
1
Location
2
Arms
28.4
Anticipated Duration (Months)
21.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual reality
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 17, 2017
Anticipated Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Jun 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. impact of the virtual reality on the pregnancy rate (Ultrasound) [12 weeks]

    measured by ultrasound

Secondary Outcome Measures

  1. impact of the virtual reality on anxiety (numeric scale) [immediate]

    measured with numeric scale (0-10) before and after the VR

  2. impact of the virtual reality on satisfaction [immediate]

    measured by a numeric scale 0-10

  3. impact of the virtual reality on pregnancy test [6 weeks]

    measured by blood beta HCG level

  4. state-trait Anxiety Inventory [immediate]

    measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques universitaires Saint-luc Brussels Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roelants, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT03064061
Other Study ID Numbers:
  • 2016/20JUL/346
First Posted:
Feb 24, 2017
Last Update Posted:
Mar 22, 2018
Last Verified:
Mar 1, 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

Study Results

No Results Posted as of Mar 22, 2018