HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit (HYPIC)

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.

Study Overview

• Status: Completed
• Conditions: Invasive Procedure
• Intervention / Treatment: Other: Hypnosis; Other: No hypnosis

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Rennes University Hospital
  • Bretagne
    • Saint-Brieuc, Bretagne, France, 22000
      • Saint-Brieuc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hypnosis group; 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; 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
PLACEBO_COMPARATOR: Control group; A control group with standard care during the invasive procedure according to the usual practice of the care team.	Other: No hypnosis; No hypnosis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2019
• Primary Completion (ACTUAL): January 25, 2022
• Study Completion (ACTUAL): October 11, 2022

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (ACTUAL): October 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: 35RC18_8853_HYPIC; 2019-A01775-52 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No