HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Study Overview
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Brief Summary
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Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.

Official Title
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HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Conditions
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Invasive Procedure

Intervention / Treatment
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* Other: Hypnosis
* Other: No hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient admitted to intensive care Glasgow score = 15 Necessity during the stay of making an invasive gesture among: Thoracic drainage Placement of a central venous catheter or a Swan-Ganz catheter Establishment of a dialysis catheter Introduction of an invasive arterial catheter Patient giving free, informed and written consent Patient affiliated to a social security scheme Non inclusion Criteria: Procedure to be carried out in extreme urgency Confusional state making hypnosis impossible, evaluated by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Decompensated psychiatric illness Patient sedated or intravenous analgesia continued at the time of the procedure Patient intubated Patient with a contraindication to sedation or analgesia at the time of the procedure Patient receiving topical anesthesia before the start of the procedure Major person subject to legal protection (court bail, curator, guardianship) or deprived of liberty Patient already included in the study during the completion of a previous invasive procedure Patient participating in a research involving an interventional human person (category 1) on an analgesic / sedative drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis group<br>A hypnosis group with standard care during the invasive procedure according to the usual practice of the care team and setting up a hypnotic accompaniment by an nurse trained beforehand and dedicated throughout the gesture. The hypnosis session will end at the same time as the invasive procedure. | Other: Hypnosis<br>* The hypnosis session : Creation of the therapist-patient link Choice of a theme and the preferred sensory channel by the patient Collection of the theme chosen by the patient Orientation in the here and now. Induction Realization of the gesture and hypnosis At the end of the procedure, reassociation of the patient in the here and now<br>|
| Placebo Comparator: Control group<br>A control group with standard care during the invasive procedure according to the usual practice of the care team. | Other: No hypnosis<br>* No hypnosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Oral assessment scale (0 : no pain - 10 : maximal pain) | Immediately after the end of the invasive procedure (Hour 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Oral assessment scale (0 : no pain - 10 : maximal pain) | The first hour after the end of the procedure (Hour 1) | 
| Morphine equivalent dose | Cumulative use of morphine-morphine analgesics in morphine equivalent during the procedure and the first hour after the end of the procedure (H1) | Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1) | 
| Sedatives dose | Cumulative use of sedatives during the procedure and the first hour after the end of the procedure (H1) | Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1) | 
| Local Anesthesia dose | Consumption of local anesthesia during the invasive procedure | Immediately after the end of the invasive procedure (Hour 0) | 
| Comfort scale | Comfort measured by the numerical comfort scale (0 no comfort - 10 most comfortable situation imaginable) | Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1) | 
| Anxiety | Patient anxiety measured by the numerical anxiety scale (0 no anxiety - 10 greatest anxiety imaginable) . | Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1) | 
| Duration | Duration of the invasive procedure including the period of hypnosis | Immediately after the end of the invasive procedure (Hour 0) | 
| Number of attempts and failures of the procedure | Number of attempts and failures of the procedure | The first hour after the end of the procedure (Hour 1) | 
| Adverse events | Number of adverse events occurring during the procedure (hematoma, failure to pose, ...) | The first hour after the end of the procedure (Hour 1) | 
| Nurse stress | Stress of the nurse in charge of the patient quantified by a numerical scale of evaluation (0 no stress - 10 greatest stress imaginable) | Immediately after the end of the invasive procedure (Hour 0) | 
| Length of stay in intensive care unit | Length of stay in intensive care unit, measured until D28 | Day 28 |