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Completed

NCT Number: NCT05092906

Contribution of Hypnosis During a Lumbar Puncture.

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.

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Key information

Conditions

Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology department of Grenoble University Hospital

Grenoble, Isere, 38043, France

About this study

This study will follow the zelen's methodology randomization. It is an add-on study design.

  • 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.
  • Patients are asked to sign the consent of the standard of care group.
  • Randomization into two equally sized groups:
  • Intervention arm : LP with complementary hypnoanalgesia
  • Control arm : LP without complementary hypnoanalgesia
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Maximum pain felt during LP

    Time frame: Immediately at the end of LP procedure

    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).

Secondary outcomes

  1. Comfort felt during LP

    Time frame: Immediately at the end of LP procedure

    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).

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

    Time frame: Immediately at the end of LP procedure

    Comparison between the two groups of the ratio of patient with a NPRS >= 4.

  3. Acceptation of hypnosis

    Time frame: Day1

    Number and percentage of subjects randomized and analyzed in the hypnoanalgesia group and who have actually had hypnosis

  4. State and Trait anxiety before LP

    Time frame: Before randomization

    The state and trait anxiety will be assess using the State and Trait anxiety inventory (STAI) questionnaire.

  5. Assess pain at Day 3 and Day 7

    Time frame: Three days and then seven days after the LP.

    The pain level will be assess using the NPRS scale by telephonic interview.

  6. Timeframe for resumption of usual activities.

    Time frame: Seven days after the LP.

    Number of days between LP and the resumption of usual activities

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: HYPNOPLUS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2021
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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