Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT05092906
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.
Study:
NCT05092906
Study Brief:
Protocol Section:
NCT05092906