Contribution of Hypnosis During a Lumbar Puncture.

Study Overview
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Brief Summary
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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
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This study will follow the zelen's methodology randomization. It is an add-on study design. 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. Patients are asked to sign the consent of the standard of care group. Randomization into two equally sized groups: Intervention arm : LP with complementary hypnoanalgesia Control arm : LP without complementary hypnoanalgesia 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.

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

Conditions
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Pain

Intervention / Treatment
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* Other: LP with complementary hypnoanalgesia
* Other: LP with standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Required a lumbar puncture for diagnosis Affiliated with social security system Patient's written consent Exclusion Criteria: LP contraindication History of previous LP Psychiatric disorder making the realization of a hypnosis irrelevant Cognitive-behavioural abilities that do not allow the completion of the study Persons who are protected under the act. Person deprived of liberty by judicial decision Pregnant or Breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lumbar puncture with standard of care<br> | Other: LP with standard of care<br>* 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<br>|
| Experimental: Lumbar puncture with hypnosis add-on therapy<br> | Other: LP with complementary hypnoanalgesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Immediately at the end of LP procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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 | Day1 | 
| State and Trait anxiety before LP | The state and trait anxiety will be assess using the State and Trait anxiety inventory (STAI) questionnaire. | Before randomization | 
| Assess pain at Day 3 and Day 7 | The pain level will be assess using the NPRS scale by telephonic interview. | 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 | Seven days after the LP. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar puncture, anxiety