Contribution of Hypnosis During a Lumbar Puncture. (HYPNOPLUS)

March 29, 2023 updated by: University Hospital, Grenoble

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Isere
      • Grenoble, Isere, France, 38043
        • Recruiting
        • Neurology department of Grenoble University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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):

  • EMLA (Lidocain+Prilocain) Cream/Patch
  • Local anesthesia with lidocain chlorhydrate monohydrate 1% injectable
  • Nitrous oxide
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2021

Primary Completion (Anticipated)

May 9, 2024

Study Completion (Anticipated)

May 9, 2024

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 38RC20.357

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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