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Lithotripsy and Analgesia With 3D Hypnosis Mask

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04869293
Acronym
LAHMA
Enrollment
106
Registered
2021-05-03
Start date
2021-04-15
Completion date
2024-02-29
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Renal Calculi

Keywords

therapeutic virtual reality, hypnosis

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.

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.

Interventions

DEVICEHypnosis 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.

Sponsors

GAMIDA
CollaboratorUNKNOWN
Healthy Mind
CollaboratorINDUSTRY
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Shock wave lithotripsy and outpatient surgery

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Remifentanil useHour 1Remifentanil consumption (microgram) during shock wave lithotripsy

Secondary

MeasureTime frameDescription
Maximal level of pain during shock wave lithotripsyHour 1Use of analogical visual pain self-assessment at the end of the shock wave lithotripsy

Countries

France

Contacts

Primary ContactDarless Clausse, MD
darless.clausse@aphp.fr331 56 09 54 11
Backup ContactNatacha Nohilé
natacha.nohile@aphp.fr331 56 09 59 82

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026