Lithotripsy and Analgesia With 3D Hypnosis Mask

Not Applicable

Recruiting

• Conditions: Renal Calculi; Pain
• Interventions: Device: Hypnosis 3D virtual reality headset

• Registration Number: NCT04869293
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2021-03-19
• Study Start: 2021-04-15
• Study First Submitted QC: 2021-04-30
• Study First Posted: 2021-05-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Shock wave lithotripsy and outpatient surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D virtual reality	Hypnosis 3D virtual reality headset	Use of Hypnosis 3D virtual reality headset

Primary Outcome Measures

Name	Time	Method
Remifentanil use	Hour 1	Remifentanil consumption (microgram) during shock wave lithotripsy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou; 🇫🇷 Paris, Île-de-France, France

Assistance Publique Hôpitaux de Paris, Necker; 🇫🇷 Paris, France