Lithotripsy and Analgesia With 3D Hypnosis Mask

Pain Clinical Trial

— LAHMA  

Official title:

Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869293
• Other study ID #: APHP200879
• Secondary ID: IDRCB 2020-A0205
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Darless Clausse, MD
• Phone: 331 56 09 54 11
• Email: darless.clausse[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Shock wave lithotripsy and outpatient surgery

Exclusion Criteria:

• Epilepsy
• Deafness, Blindness
• Schizophrenia, Hallucinations
• No french-speaking
• Autistic
• Motion sickness

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Pain
• Renal Calculi

Intervention

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.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou	Paris	Île-de-France
France	Assistance Publique Hôpitaux de Paris, Necker	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	GAMIDA, Healthy Mind

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

Scapin S, Echevarria-Guanilo ME, Boeira Fuculo Junior PR, Goncalves 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remifentanil use	Remifentanil consumption (microgram) during shock wave lithotripsy	Hour 1
Secondary	Maximal level of pain during shock wave lithotripsy	Use of analogical visual pain self-assessment at the end of the shock wave lithotripsy	Hour 1