Improvement of the Performance of Lumbar Punctures After Training Students With an Augmented Reality SIMulator

NCT ID: NCT05269238

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2023-11-15

Brief Summary

Lumbar punctures (LP) are frequent invasive procedures that are anxiety-provoking for both the patient and the clinicans performing the procedure. LP is performed by many practitioners, whether they are emergency physicians, neurologists, neurosurgeons, internists or rheumatologists. Learning how to perform LP is essentially done at the patient's bed by showing the students how a procedure is performed and then having them perform it directly on a patient afterwards. The recent development of simulation in health care with the credo "never the first time on the patient" requires the development of training devices faithful to reality.

The rheumatology department of the Strasbourg University Hospital has been working for 3 years, in collaboration with the Strasbourg start-up InSimo, on the development of an LP simulator. This simulator is original because it allows the feeling by pressure of the passage of the various structures, and in particular the yellow ligament. This sensation is made possible by a haptic force feedback device.

Conditions

Lumbar Puncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

control group patient

performing lumbar punctures by students with standard training

Group Type: OTHER

performing lumbar punctures by students with standard training

Intervention Type: OTHER

performance of the puncture by the student have been previously trained with standard training

experimental group patient

performing lumbar punctures by students with standard training and an augmented reality simulator

Group Type: EXPERIMENTAL

training students augmented reality simulator

Intervention Type: OTHER

performance of the puncture by the student have been previously trained using the augmented reality simulator

Interventions

performing lumbar punctures by students with standard training

performance of the puncture by the student have been previously trained with standard training

Intervention Type: OTHER

training students augmented reality simulator

performance of the puncture by the student have been previously trained using the augmented reality simulator

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Requiring a lumbar puncture as part of their routine care
• Male or female of legal age with no upper age limit
• French speaking
• Subject affiliated to a social health insurance scheme
• Not having expressed his or her opposition to the re-use of his or her data in the context of this research

Exclusion Criteria

• Previously undergone a lumbar puncture
• BMI > 35 kg/m².
• Spinal ankylosis: history of ankylosing spondylitis or Forestier's disease
• Impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
• Subject under court protection
• Subject under guardianship or curatorship
• Contraindication to the use of Emlapatch

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

References

Felten R, Bigaut K, Wirth T, Kremer L, Gauer L, Arnold C, Ollivier I, Godet J, Scherlinger M, Dubois M, Sebbag E, De Seze J, Gottenberg JE. Advancing medical training with augmented reality and haptic feedback simulator: outcomes of a randomized controlled trial on lumbar puncture. BMC Med Educ. 2025 Aug 30;25(1):1231. doi: 10.1186/s12909-025-07536-6.

Reference Type: RESULT

PMID: 40885925 (View on PubMed)

Other Identifiers

8074

Identifier Type: -

Identifier Source: org_study_id