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

Primary Purpose

Invasive Procedure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis
No hypnosis
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Invasive Procedure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint-Brieuc Hospital
  • Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hypnosis group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Pain assessment
Oral assessment scale (0 : no pain - 10 : maximal pain)

Secondary Outcome Measures

Pain assessment
Oral assessment scale (0 : no pain - 10 : maximal pain)
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)
Sedatives dose
Cumulative use of sedatives during the procedure and the first hour after the end of the procedure (H1)
Local Anesthesia dose
Consumption of local anesthesia during the invasive procedure
Comfort scale
Comfort measured by the numerical comfort scale (0 no comfort - 10 most comfortable situation imaginable)
Anxiety
Patient anxiety measured by the numerical anxiety scale (0 no anxiety - 10 greatest anxiety imaginable) .
Duration
Duration of the invasive procedure including the period of hypnosis
Number of attempts and failures of the procedure
Number of attempts and failures of the procedure
Adverse events
Number of adverse events occurring during the procedure (hematoma, failure to pose, ...)
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)
Length of stay in intensive care unit
Length of stay in intensive care unit, measured until D28

Full Information

First Posted
October 14, 2019
Last Updated
November 8, 2022
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04129333
Brief Title
HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
Acronym
HYPIC
Official Title
HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Procedure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
A control group with standard care during the invasive procedure according to the usual practice of the care team.
Intervention Type
Other
Intervention Name(s)
Hypnosis
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
No hypnosis
Intervention Description
No hypnosis
Primary Outcome Measure Information:
Title
Pain assessment
Description
Oral assessment scale (0 : no pain - 10 : maximal pain)
Time Frame
Immediately after the end of the invasive procedure (Hour 0)
Secondary Outcome Measure Information:
Title
Pain assessment
Description
Oral assessment scale (0 : no pain - 10 : maximal pain)
Time Frame
The first hour after the end of the procedure (Hour 1)
Title
Morphine equivalent dose
Description
Cumulative use of morphine-morphine analgesics in morphine equivalent during the procedure and the first hour after the end of the procedure (H1)
Time Frame
Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
Title
Sedatives dose
Description
Cumulative use of sedatives during the procedure and the first hour after the end of the procedure (H1)
Time Frame
Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
Title
Local Anesthesia dose
Description
Consumption of local anesthesia during the invasive procedure
Time Frame
Immediately after the end of the invasive procedure (Hour 0)
Title
Comfort scale
Description
Comfort measured by the numerical comfort scale (0 no comfort - 10 most comfortable situation imaginable)
Time Frame
Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
Title
Anxiety
Description
Patient anxiety measured by the numerical anxiety scale (0 no anxiety - 10 greatest anxiety imaginable) .
Time Frame
Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
Title
Duration
Description
Duration of the invasive procedure including the period of hypnosis
Time Frame
Immediately after the end of the invasive procedure (Hour 0)
Title
Number of attempts and failures of the procedure
Description
Number of attempts and failures of the procedure
Time Frame
The first hour after the end of the procedure (Hour 1)
Title
Adverse events
Description
Number of adverse events occurring during the procedure (hematoma, failure to pose, ...)
Time Frame
The first hour after the end of the procedure (Hour 1)
Title
Nurse stress
Description
Stress of the nurse in charge of the patient quantified by a numerical scale of evaluation (0 no stress - 10 greatest stress imaginable)
Time Frame
Immediately after the end of the invasive procedure (Hour 0)
Title
Length of stay in intensive care unit
Description
Length of stay in intensive care unit, measured until D28
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Saint-Brieuc Hospital
City
Saint-Brieuc
State/Province
Bretagne
ZIP/Postal Code
22000
Country
France
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

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