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

NCT05269238 | Completed DMC

• 1 other identifier: 8074
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

lumbar puncture; simulator

Outcome Measures

Primary Outcomes (1)

• Success rate of lumbar punctures in patients according to whether the students performing their first lumbar puncture were previously trained to perform this invasive procedure using the augmented reality simulator versus standard teaching.

  Success rate of lumbar puncture as assessed by the collection of cerebrospinal fluid (CSF) at the end of the procedure. A successful LP is defined as the collection of CSF at the end of the procedure performed by the student without the assistance of a senior physician or resident and without interruption of the procedure by the patient.

  3 days

Study Arms (2)

control group patient

OTHER

performing lumbar punctures by students with standard training

Other: performing lumbar punctures by students with standard training

experimental group patient

EXPERIMENTAL

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

Other: training students augmented reality simulator

Interventions

training students augmented reality simulator OTHER

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

experimental group patient

performing lumbar punctures by students with standard training OTHER

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

control group patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 40885925 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: March 7, 2022
• Study Start: December 2, 2021
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

FR (1)