Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Maximum pain felt during LP
Overview
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.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.(Immediately at the end of LP procedure)
- Comfort felt during LP(Immediately at the end of LP procedure)
- Acceptation of hypnosis(Day1)
- State and Trait anxiety before LP(Before randomization)
- Assess pain at Day 3 and Day 7(Three days and then seven days after the LP.)
- Timeframe for resumption of usual activities.(Seven days after the LP.)