Lithotripsy and Analgesia With 3D Hypnosis Mask (LAHMA)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Renal Calculi; Pain

Treatments: Device: Hypnosis 3D virtual reality headset

Study type: Interventional

Funder types: Other

Identifiers

NCT04869293

IDRCB 2020-A02052-37 (Other Identifier)

APHP200879

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Shock wave lithotripsy and outpatient surgery

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

106 participants in 2 patient groups

3D virtual reality

Experimental group

Description:

Use of Hypnosis 3D virtual reality headset

Treatment:

Device: Hypnosis 3D virtual reality headset

Control

No Intervention group

Description:

Standard of care : no hypnosis 3D virtual reality headset but a noise cancelling headphone