Hypnosis During Mechanical Ventilation Weaning

NCT07518498 | Not Yet Recruiting

• 1 other identifier: 2025PI107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypnosis; Weaning Mechanical Ventilation; Hypnosis During Weaning From Invasive Mechanical Ventilation

Keywords

Hypnosis; Weaning Mechanical Ventilation; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Progression of pain and anxiety during weaning from invasive mechanical ventilation using hypnosis.

  During the hypnosis session (Day 1)

• Frequency of failed weaning from invasive mechanical ventilation among patients who underwent a hypnosis session.

  During ICU stay

• Complications associated with weaning from mechanical ventilation using hypnosis.

  During the ICU stay

• Length of stay in the intensive care unit following weaning from mechanical ventilation using hypnosis.

  ICU stay

• Mortality following weaning from mechanical ventilation using hypnosis.

  At day 28

Study Arms (1)

Patients on invasive mechanical ventilation

EXPERIMENTAL

Behavioral: Hypnosis

Interventions

Hypnosis BEHAVIORAL

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.

Patients on invasive mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Centre Hospitalier Régional Metz-Thionville: collaborator

Study Sites (1)

Central Hospital

Nancy, 54000, France

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Viviane MARTIN, PhD

  The Regional and University Hospital Center of Nancy

  STUDY DIRECTOR

Central Study Contacts

Sébastien Gibot, MD

CONTACT

+ 33 383851495; s.gibot@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

FR (1)