Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 4:45 AM
Study NCT ID:
NCT05092906
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2021-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Hypnosis During a Lumbar Puncture.
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
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:
HYPNOPLUS
Brief Summary:
The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management.
Detailed Description:
This study will follow the zelen's methodology randomization. It is an add-on study design.
1. The study will be presented to patients as an assessment of their comfort during the LP. The intervention group is not presented to the patient.
2. Patients are asked to sign the consent of the standard of care group.
3. Randomization into two equally sized groups:
* Intervention arm : LP with complementary hypnoanalgesia
* Control arm : LP without complementary hypnoanalgesia
4. Patients who have been randomized into the control group, will have LP according to the standard of care.
Patients who have been randomized into the hypnoanalgesic group will be informed about the hypnoanalgesia intervention and then asked to sign the consent of the hypnosis group.
* if the patient accepts, he will benefit from hypnosis during LP.
* if the patient refuses, he will re-join the control group without hypnosis.
The physicians performing LP will be the same in both groups. A phone call follow-up is scheduled on day 3 and 7 after intervention.
1. The study will be presented to patients as an assessment of their comfort during the LP. The intervention group is not presented to the patient.
2. Patients are asked to sign the consent of the standard of care group.
3. Randomization into two equally sized groups:
* Intervention arm : LP with complementary hypnoanalgesia
* Control arm : LP without complementary hypnoanalgesia
4. Patients who have been randomized into the control group, will have LP according to the standard of care.
Patients who have been randomized into the hypnoanalgesic group will be informed about the hypnoanalgesia intervention and then asked to sign the consent of the hypnosis group.
* if the patient accepts, he will benefit from hypnosis during LP.
* if the patient refuses, he will re-join the control group without hypnosis.
The physicians performing LP will be the same in both groups. A phone call follow-up is scheduled on day 3 and 7 after intervention.
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?: