Virtual Reality Simulation for Intrauterine Device Insertion: A Randomized Clinical Trial (VR-IUD)

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Conditions

IUD

Treatments

Device: Virtual Reality

Study type

Interventional

Funder types

Other

Identifiers

NCT04389021

S63124

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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