Contribution of Hypnosis During a Lumbar Puncture.

NCT ID: NCT05092906

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2024-03-13

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lumbar puncture with standard of care

Group Type: ACTIVE_COMPARATOR

LP with standard of care

Intervention Type: OTHER

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

Lumbar puncture with hypnosis add-on therapy

Group Type: EXPERIMENTAL

LP with complementary hypnoanalgesia

Intervention Type: OTHER

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.

Interventions

LP with complementary hypnoanalgesia

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.

Intervention Type: OTHER

LP 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Neurology department of Grenoble University Hospital

Grenoble, Isere, France

Countries

France

Other Identifiers

38RC20.357

Identifier Type: -

Identifier Source: org_study_id