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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03064061
• Other study ID #: 2016/20JUL/346
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2016
• Last updated: March 20, 2018
• Start date: February 17, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2018
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• in Vitro Fertilization
• Virtual Reality

Intervention

Device:
• Virtual reality
a device with virtual reality is given to the patients with a film of 18 minutes

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	impact of the virtual reality on the pregnancy rate (Ultrasound)	measured by ultrasound	12 weeks
Secondary	impact of the virtual reality on anxiety (numeric scale)	measured with numeric scale (0-10) before and after the VR	immediate
Secondary	impact of the virtual reality on satisfaction	measured by a numeric scale 0-10	immediate
Secondary	impact of the virtual reality on pregnancy test	measured by blood beta HCG level	6 weeks
Secondary	state-trait Anxiety Inventory	measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital	immediate