- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092906
Contribution of Hypnosis During a Lumbar Puncture. (HYPNOPLUS)
Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mathieu Vaillant, MD
- Phone Number: 33 04 76 76 75 75
- Email: Mvaillant@chu-grenoble.fr
Study Locations
-
-
Isere
-
Grenoble, Isere, France, 38043
- Recruiting
- Neurology department of Grenoble University Hospital
-
Contact:
- Mathieur Vaillant, MD
- Phone Number: 33 0476767575
- Email: Mvaillant@chu-grenoble.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lumbar puncture 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):
|
Experimental: Lumbar puncture with hypnosis add-on therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum pain felt during LP
Time Frame: Immediately at the end of LP procedure
|
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
Time Frame: Immediately at the end of LP procedure
|
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.
Time Frame: Immediately at the end of LP procedure
|
Comparison between the two groups of the ratio of patient with a NPRS >= 4.
|
Immediately at the end of LP procedure
|
Acceptation of hypnosis
Time Frame: Day1
|
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
Time Frame: Before randomization
|
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
Time Frame: Three days and then seven days after the LP.
|
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.
Time Frame: Seven days after the LP.
|
Number of days between LP and the resumption of usual activities
|
Seven days after the LP.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 38RC20.357
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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