Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 3:34 AM
Study NCT ID:
NCT04869293
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lithotripsy and Analgesia With 3D Hypnosis Mask
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAHMA
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB 2020-A02052-37 | OTHER | ANSM | View |