Clinical trial NCT04129333: HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
Official title: HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Procedure
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Pain assessment
timeFrame: Immediately after the end of the invasive procedure (Hour 0)
Secondary outcomes:
measure: Pain assessment
timeFrame: The first hour after the end of the procedure (Hour 1)
measure: Morphine equivalent dose
timeFrame: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
measure: Sedatives dose
timeFrame: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
measure: Local Anesthesia dose
timeFrame: Immediately after the end of the invasive procedure (Hour 0)
measure: Comfort scale
timeFrame: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
measure: Anxiety
timeFrame: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
measure: Duration
timeFrame: Immediately after the end of the invasive procedure (Hour 0)
measure: Number of attempts and failures of the procedure
timeFrame: The first hour after the end of the procedure (Hour 1)
measure: Adverse events
timeFrame: The first hour after the end of the procedure (Hour 1)
measure: Nurse stress
timeFrame: Immediately after the end of the invasive procedure (Hour 0)
measure: Length of stay in intensive care unit
timeFrame: Day 28
Other outcomes:
Locations:
city: Saint-Brieuc
country: France
facility: Saint-Brieuc Hospital
state: Bretagne
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
References: