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

NCT04389021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-04-27

No results posted yet for this study

Summary

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

Conditions

  • IUD

Interventions

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.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-12-30
Completion
2021-01-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04389021 on ClinicalTrials.gov