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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
74
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.
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
Neurology department of Grenoble University Hospital
Grenoble, Isere, France
Maximum pain felt during LP
The maximum pain experienced will be assessed in the immediate post procedure using a Numeric Pain Rating Scale (NPRS). The NPRS is a 10 points scale, ranging from 0 (no pain) to 10 (maximal pain).
Time frame: Immediately at the end of LP procedure
Comfort felt during LP
The comfort level felt during the LP procedure will be assessed with a Numeric Rating Scale (NRS). The NRS is a 10 points scale, ranging from 0 (total uncomfort) to 10 (maximal comfort).
Time frame: Immediately at the end of LP procedure
Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.
Comparison between the two groups of the ratio of patient with a NPRS \>= 4.
Time frame: Immediately at the end of LP procedure
Acceptation of hypnosis
Number and percentage of subjects randomized and analyzed in the hypnoanalgesia group and who have actually had hypnosis
Time frame: Day1
State and Trait anxiety before LP
The state and trait anxiety will be assess using the State and Trait anxiety inventory (STAI) questionnaire.
Time frame: Before randomization
Assess pain at Day 3 and Day 7
The pain level will be assess using the NPRS scale by telephonic interview.
Time frame: Three days and then seven days after the LP.
Timeframe for resumption of usual activities.
Number of days between LP and the resumption of usual activities
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Time frame: Seven days after the LP.