LAHMA: Lithotripsy and Analgesia With 3D Hypnosis Mask

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04869293
• Collaborator: GAMIDA (Other), Healthy Mind (Other)
• Enrollment: 106
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site: 53
• Patients Per Site Per Month: 8.8

Study Details

Study Description

Brief Summary

The study is a randomised trial of hypnosis with 3D virtual reality headset (intervention group) versus control group with no hypnosis and no virtual reality headset to compare remifentanil consumption during shock wave lithotripsy.

Condition or Disease	Intervention/Treatment	Phase
Renal Calculi; Pain	Device: Hypnosis 3D virtual reality headset	N/A

Detailed Description

The study is for patients undergoing shock wave lithotripsy in outpatient surgery unit.

It is proposed that using hypnosis with 3D virtual reality headset will reduce the requirements for intravenous remifentanil in a randomised controlled trial of one hundred and six patients.

Remifentanil is an opioid commonly used for lithotripsy. Shock wave lithotripsy is a commonly performed procedure associated with moderate pain and anxiety, in outpatient surgery unit. Opioids can cause unfavourable side-effects, most notably respiratory depression, sedation, nausea and vomiting

It is expected that by using 3D virtual reality to reduce pain and anxiety, there will be a reduced requirement for intravenous remifentanil.

The study will measure the dose of remifentanil required by patients randomised to receive either hypnosis with 3D virtual reality headset (intervention) or no hypnosis and no 3D virtual reality headset (control group).

Patients will be followed up prior to hospital discharge to assess their remifentanil use and pain, anxiety, comfort and their satisfaction with 3D virtual reality headset.

This new device is a non-pharmacological adjunct and can reduce pain intensity during procedure, reduce opioid use and length of stay in hospital and improve the patient experience whilst potentially reducing complications of intravenous opioid.

This study findings will be of interest for patients involved in surgery or investigative procedures normally carried out with intravenous opioids or sedation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Oct 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D virtual reality Use of Hypnosis 3D virtual reality headset	Device: Hypnosis 3D virtual reality headset; 3D experience to journey through a natural and therapeutic environment. Immersion is amplified by the realism of 3D environment, a soothing sound atmosphere and specific medical hypnosis.
No Intervention: Control Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone

Outcome Measures

Primary Outcome Measures

1. Remifentanil use [Hour 1]

   Remifentanil consumption (microgram) during shock wave lithotripsy

Secondary Outcome Measures

1. Maximal level of pain during shock wave lithotripsy [Hour 1]

   Use of analogical visual pain self-assessment at the end of the shock wave lithotripsy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Shock wave lithotripsy and outpatient surgery

Exclusion Criteria:

• Epilepsy

• Deafness, Blindness

• Schizophrenia, Hallucinations

• No french-speaking

• Autistic

• Motion sickness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Paris, Necker	Paris		France
2	Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou	Paris	Île-de-France	France	75015

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris
• GAMIDA
• Healthy Mind

Investigators

• Principal Investigator: Darless Clausse, MD, Hôpital européen Geroges-Pompidou

Study Documents (Full-Text)

None provided.

More Information

Publications

• Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.
• Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
• Scapin S, Echevarría-Guanilo ME, Boeira Fuculo Junior PR, Gonçalves N, Rocha PK, Coimbra R. Virtual Reality in the treatment of burn patients: A systematic review. Burns. 2018 Sep;44(6):1403-1416. doi: 10.1016/j.burns.2017.11.002. Epub 2018 Feb 1.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04869293
• Other Study ID Numbers: APHP200879; IDRCB 2020-A02052-37
• First Posted: May 3, 2021
• Last Update Posted: May 3, 2021
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: therapeutic virtual reality; hypnosis
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi

Study Results

No Results Posted as of May 3, 2021