NCT05092906

Contribution of Hypnosis During a Lumbar Puncture.

Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	LP with complementary hypnoanalgesia	The lumbar puncture technique will be identical to that of the group standard of care. Hypnosis will be performed by a health professional trained in this practice, in addition to the standard analgesic management.
OTHER	LP with standard of care	The LP will be carried out according to the usual techniques without hypnosis. Standard analgesic treatments will be used (except contraindications): * EMLA (Lidocain+Prilocain) Cream/Patch * Local anesthesia with lidocain chlorhydrate monohydrate 1% injectable * Nitrous oxide

Timeline

• Start date: 2021-11-09
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2021-10-26
• Last updated: 2024-06-14

Locations

1 site across 1 country: France