Contribution of Hypnosis During a Lumbar Puncture. (HYPNOPLUS)

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

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: LP with standard of care; Other: LP with complementary hypnoanalgesia

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 (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Isere
    • Grenoble, Isere, France, 38043
      • Neurology department of Grenoble University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lumbar puncture with standard of care	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
Experimental: Lumbar puncture with hypnosis add-on therapy	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort felt during LP	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.	Comparison between the two groups of the ratio of patient with a NPRS >= 4.	Immediately at the end of LP procedure
Acceptation of hypnosis	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	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	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.	Number of days between LP and the resumption of usual activities	Seven days after the LP.

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 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): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; lumbar puncture
• 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