Contribution of Hypnosis During a Lumbar Puncture. (HYPNOPLUS)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Pain

Treatments: Other: LP with complementary hypnoanalgesia; Other: LP with standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05092906

38RC20.357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Lumbar puncture with standard of care

Active Comparator group

Treatment:

Other: LP with standard of care

Lumbar puncture with hypnosis add-on therapy

Experimental group

Treatment:

Other: LP with complementary hypnoanalgesia