Contribution of Hypnosis During a Lumbar Puncture.

NCT05092906 | Completed

• 1 other identifier: 38RC20.357
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

lumbar puncture; anxiety

Outcome Measures

Primary Outcomes (1)

• Maximum pain felt during LP

  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 Outcomes (6)

• Comfort felt during LP

  Immediately at the end of LP procedure

• Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.

  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.

Study Arms (2)

Lumbar puncture with standard of care

ACTIVE COMPARATOR

Other: LP with standard of care

Lumbar puncture with hypnosis add-on therapy

EXPERIMENTAL

Other: LP with complementary hypnoanalgesia

Interventions

LP with complementary hypnoanalgesia 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.

Lumbar puncture with hypnosis add-on therapy

LP with standard of care 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 standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Required a lumbar puncture for diagnosis
• Affiliated with social security system
• Patient's written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Neurology department of Grenoble University Hospital

Grenoble, Isere, 38043, France

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 26, 2021
• Study Start: November 9, 2021
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

FR (1)