NCT04389021

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• IUD

Interventions

Type	Name	Description
DEVICE	Virtual Reality	The VR goggles have a 2560×1440 5.5" (538ppi) fast-switching LCD screen with standard 60Hz refresh, "overclocked" 72Hz refresh, running Android 7.1.2 Nougat with a Quad-core Qualcomm Snapdragon 821 (two 2.3GHz Kryo HP cores and two 2.15GHz Kryo cores). Adreno 530 as GPU. It is 190 x 105 x 115 mm en weighs 470 g (1.04 lbs). The goggles have built-in speakers, a controller, proximity sensor, 3DOF sensors (both headset and controller). Any pre-procedural self-administration of pain medication will be recorded. Trained staff-members or senior residents will do all IUD insertions, according to the local protocol.

Timeline

• Start date: 2020-03-01
• Primary completion: 2020-12-30
• Completion: 2021-01-01
• First posted: 2020-05-15
• Last updated: 2021-04-27

Locations

1 site across 1 country: Belgium