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

November 8, 2022 updated by: Rennes University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: Immediately after the end of the invasive procedure (Hour 0)
Oral assessment scale (0 : no pain - 10 : maximal pain)
Immediately after the end of the invasive procedure (Hour 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: The first hour after the end of the procedure (Hour 1)
Oral assessment scale (0 : no pain - 10 : maximal pain)
The first hour after the end of the procedure (Hour 1)
Morphine equivalent dose
Time Frame: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
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
Time Frame: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
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
Time Frame: Immediately after the end of the invasive procedure (Hour 0)
Consumption of local anesthesia during the invasive procedure
Immediately after the end of the invasive procedure (Hour 0)
Comfort scale
Time Frame: Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1)
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
Time Frame: Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1)
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
Time Frame: Immediately after the end of the invasive procedure (Hour 0)
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
Time Frame: The first hour after the end of the procedure (Hour 1)
Number of attempts and failures of the procedure
The first hour after the end of the procedure (Hour 1)
Adverse events
Time Frame: The first hour after the end of the procedure (Hour 1)
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
Time Frame: Immediately after the end of the invasive procedure (Hour 0)
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
Time Frame: Day 28
Length of stay in intensive care unit, measured until D28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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