HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Sponsor

Rennes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04129333

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Procedure	Other: Hypnosis Other: No hypnosis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groupsMulticenter prospective national, controlled, randomized, superiority study, open-label with blind evaluation, on 2 parallel groups

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Actual Study Start Date :

Dec 30, 2019

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain assessment [Immediately after the end of the invasive procedure (Hour 0)]
Oral assessment scale (0 : no pain - 10 : maximal pain)

Secondary Outcome Measures

Pain assessment [The first hour after the end of the procedure (Hour 1)]
Oral assessment scale (0 : no pain - 10 : maximal pain)
Morphine equivalent dose [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)
Sedatives dose [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)
Local Anesthesia dose [Immediately after the end of the invasive procedure (Hour 0)]
Consumption of local anesthesia during the invasive procedure
Comfort scale [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)
Anxiety [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) .
Duration [Immediately after the end of the invasive procedure (Hour 0)]
Duration of the invasive procedure including the period of hypnosis
Number of attempts and failures of the procedure [The first hour after the end of the procedure (Hour 1)]
Number of attempts and failures of the procedure
Adverse events [The first hour after the end of the procedure (Hour 1)]
Number of adverse events occurring during the procedure (hematoma, failure to pose, ...)
Nurse stress [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)
Length of stay in intensive care unit [Day 28]
Length of stay in intensive care unit, measured until D28

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

on an analgesic / sedative drug

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint-Brieuc Hospital	Saint-Brieuc	Bretagne	France	22000
2	Rennes University Hospital	Rennes		France	35033

Sponsors and Collaborators

Rennes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT04129333

Other Study ID Numbers:

35RC18_8853_HYPIC
2019-A01775-52

First Posted:

Oct 16, 2019

Last Update Posted:

Jun 1, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Procedural

Study Results

No Results Posted as of Jun 1, 2021