Contribution of Hypnosis During a Lumbar Puncture.

Pain Clinical Trial

— HYPNOPLUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05092906
• Other study ID #: 38RC20.357
• Status: Completed
• Phase: N/A
• Start date: November 9, 2021
• Est. completion date: March 13, 2024

Study information

• Verified date: June 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 13, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Neurology department of Grenoble University Hospital	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Acceptation of hypnosis	Number and percentage of subjects randomized and analyzed in the hypnoanalgesia group and who have actually had hypnosis	Day1
Secondary	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
Secondary	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.
Secondary	Timeframe for resumption of usual activities.	Number of days between LP and the resumption of usual activities	Seven days after the LP.