Virtual Reality Simulation for Intrauterine Device Insertion: A Randomized Clinical Trial

Clinical Effectiveness of Virtual Reality Simulation in Reducing Discomfort, Anxiety and Pain During Intrauterine Device Insertion: A Randomized Clinical Trial

Aim of this study is to evaluate the effect of VR on the patients overall experience during the IUD insertion procedure.

A single center, investigator initiated randomized controlled clinical trial. 200 women to be recruited, 100 in the intervention group and 100 in the control group.

The control group will receive the usual treatment (without specific pain management) and the intervention group will receive the usual treatment with VR support.

Endpoints are:

• Objective: successful procedure, need for general anesthesia, presence of syncope and/or vomitus
• Subjective: Pain, procedural cooperation, the degree of difficulty encountered by the physician in performing the treatment, ability to complete VR procedure.

Inclusion Criteria:

• Healthy women who are seeking hormonal intrauterine contraception will be offered participation in the trial if they are 18 years of age or older (minors can be included if a guardians permission has been obtained), are not pregnant, and are willing to follow-up after 6 weeks for a sonographic IUD check.

Exclusion Criteria:

• Epilepsy
• Auditive or visual disabilities
• Invalidating claustrophobia