Hypnosis During Mechanical Ventilation Weaning (HYPREA)

Hypnosis During Mechanical Ventilation Weaning : Feasibility and Physiological Impact

Hypnosis is defined as an altered state of consciousness characterized by an increased susceptibility to suggestion. It is a technique commonly used in the medical field, primarily for the management of pain and anxiety.

The literature demonstrates that better pain management is correlated with a shorter length of stay in the ICU and a shorter duration of mechanical ventilation.

In patients hospitalized in the ICU requiring invasive mechanical ventilation, the emotional component plays a significant role in dyspnea, which can become an obstacle to weaning from ventilation. The analgesic and anxiolytic treatments used carry numerous side effects and contraindications, limiting their use in ICU patients. Furthermore, pulmonary edema is a common cause of failure to wean from invasive mechanical ventilation. By reducing the occurrence of hypertension and tachycardia, hypnosis could be used as a therapeutic strategy to limit its incidence. Thus, hypnosis could be a valuable therapeutic tool for improving tolerance and the success of ventilator weaning.

Although hypnosis is already commonly used in intensive care units, its use is still limited by a lack of evidence for more specific indications. It is in this context that this study was conducted, to assess the feasibility of conducting a hypnosis session during weaning from invasive mechanical ventilation in the intensive care unit.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypnosis; Weaning Mechanical Ventilation; Hypnosis During Weaning From Invasive Mechanical Ventilation
• Intervention / Treatment: Behavioral: Hypnosis

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien Gibot, MD; Phone Number: + 33 383851495; Email: s.gibot@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Central Hospital
    • Contact: Sébastien Gibot, MD; Phone Number: + 33 383851495; Email: s.gibot@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 and older
• Patients hospitalized in the intensive care unit and requiring invasive mechanical ventilation for at least 48 hours
• Presence of the prerequisite criteria for ventilator weaning: effective cough, minimal bronchial congestion, patient awake and not agitated, hemodynamic stability (heart rate less than 140 beats per minute, systolic blood pressure between 90 and 160 mmHg without vasopressors), pressure support ventilation, FiO2 < 40% and PEEP ≤ 8 cmH2O, PaO2/FiO2 > 150, pH > 7.35, respiratory rate < 35 per minute
• Patients enrolled in a social security program or eligible for such a program
• Patients who has received complete information about the clinical research protocol and has signed an informed consent form
• Patients who has undergone a preliminary clinical examination appropriate for the clinical research

Exclusion Criteria:

• Contraindication to hypnosis (particularly severe psychotic disorders)
• Non-French-speaking individuals
• Deaf or hard-of-hearing individuals
• State of agitation or acute delirium
• Individuals who have already undergone a spontaneous ventilation test or an attempt at orotracheal extubation during their hospitalization
• Individuals receiving a new anxiolytic or sedative treatment within 2 hours prior to the weaning test
• Individuals with a tracheostomy
• Women of childbearing age who do not have access to effective contraception
• Individuals covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the Public Health Code (pregnant women, women in labor, or breastfeeding women, minors not emancipated, adult subject to a legal protection measure, adult unable to give consent)
• Person deprived of liberty by a judicial or administrative decision, or a person receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients on invasive mechanical ventilation	Behavioral: Hypnosis; The intervention consists of a standardized hypnosis session delivered by a trained practitioner during the weaning phase from invasive mechanical ventilation in an intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a hypnosis session during weaning from invasive mechanical ventilation.	Number of hypnosis sessions conducted, relative to the number of eligible patients.	At the end of the recruitment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of pain and anxiety during weaning from invasive mechanical ventilation using hypnosis.	Assessment of pain and anxiety using visual analog scales before and after the hypnosis session.	During the hypnosis session (Day 1)
Frequency of failed weaning from invasive mechanical ventilation among patients who underwent a hypnosis session.	Ventilator weaning failure rate.	During ICU stay
Complications associated with weaning from mechanical ventilation using hypnosis.	Number and types of complications.	During the ICU stay
Length of stay in the intensive care unit following weaning from mechanical ventilation using hypnosis.	Length of stay in the intensive care unit.	ICU stay
Mortality following weaning from mechanical ventilation using hypnosis.	Death rate	At day 28
Patients' experiences	Form for patients who received hypnosis during weaning from mechanical ventilation.	On the day of discharge from the ICU, and no later than Day 28
Professionals' perceptions of hypnosis	Form for healthcare professionals who have conducted at least one hypnosis session.	Throughout the study's enrollment period.

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Centre Hospitalier Régional Metz-Thionville
• Investigators: Study Director: Viviane MARTIN, PhD, The Regional and University Hospital Center of Nancy

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypnosis; Intensive care unit; Weaning Mechanical Ventilation
• Additional Relevant MeSH Terms: Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis
• Other Study ID Numbers: 2025PI107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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