HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Invasive Procedure Clinical Trial

— HYPIC  

Official title:

HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129333
• Other study ID #: 35RC18_8853_HYPIC
• Secondary ID: 2019-A01775-52
• Status: Completed
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: October 11, 2022

Study information

• Verified date: November 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 11, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Invasive Procedure
• Pain, Procedural

Intervention

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
• No hypnosis
No hypnosis

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes
France	Saint-Brieuc Hospital	Saint-Brieuc	Bretagne

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	Oral assessment scale (0 : no pain - 10 : maximal pain)	Immediately after the end of the invasive procedure (Hour 0)
Secondary	Pain assessment	Oral assessment scale (0 : no pain - 10 : maximal pain)	The first hour after the end of the procedure (Hour 1)
Secondary	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)
Secondary	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)
Secondary	Local Anesthesia dose	Consumption of local anesthesia during the invasive procedure	Immediately after the end of the invasive procedure (Hour 0)
Secondary	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)
Secondary	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)
Secondary	Duration	Duration of the invasive procedure including the period of hypnosis	Immediately after the end of the invasive procedure (Hour 0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Length of stay in intensive care unit	Length of stay in intensive care unit, measured until D28	Day 28