HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Rennes University Hospital

Status: Completed

Conditions: Invasive Procedure

Treatments: Other: Hypnosis; Other: No hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04129333

2019-A01775-52 (Other Identifier)

35RC18_8853_HYPIC

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Hypnosis group

Experimental group

Description:

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.

Treatment:

Other: Hypnosis

Control group

Placebo Comparator group

Description:

A control group with standard care during the invasive procedure according to the usual practice of the care team.

Treatment:

Other: No hypnosis