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NOT YET RECRUITING
NCT06926231
NA

Non-medicinal Technique and Dyspnea in Weaning Patients

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

This is a randomized, controlled, multicenter, open-label, category 2, parallel-arm study of efficacy and superiority. The target population are patients hospitalized in the intensive care unit (ICU), ventilated with invasive mechanical ventilation for 24 hours or more and having failed a spontaneous breathing trial (SBT, i.e. weaning test of invasive mechanical ventilation \[IMV\]). The primary objective is to evaluate the efficacy of medical hypnosis in reducing dyspnea experienced before the SBT in patients identified as difficult to wean in the ICU, compared with the protocolized standard of care. The primary outcome is the mean value of the daily visual analog scale (VAS) of dyspnea, self-assessed by the patient, measured immediately after the hypnosis session (before SBT) from Day-0 to Day-7 or until extubation. In the control group, the daily value (from D0 to D7 or extubation) of the self-assessed dyspnea VAS will be measured immediately before SBT. The protocol will be divided into two arms: a control arm in which standard of care practices regarding the daily SBT will be protocolized, and an interventional arm in which patients will receive protocolized medical hypnosis before the daily SBT in addition to the protocolized standard of care. The intervention (hypnosis or control) will be performed daily for 7 days (or until extubation, if applicable). The primary outcome will be assessed daily over the same period.

Official title: Impact of a Non-medicinal Technique Medical Hypnosis on Perceived Dyspnea in Difficult Ventilatory Weaning Patients: a Multicenter Randomized Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2025-06-01

Completion Date

2027-06-01

Last Updated

2025-05-23

Healthy Volunteers

No

Interventions

BEHAVIORAL

Protocolized medical hypnosis

Patients who will receive protocolized medical hypnosis before the SBT every day between inclusion and day 7. Medical hypnosis sessions will consist in the administration of a 5-min hypnotic text by a loudspeaker installed in the ICU room, after selection of a hypnotic theme (sea, mountain or animals) by the participant. The hypnosis session will involve an induction phase, a suggestion phase and an emergence phase, along with self-hypnosis tips. The hypnosis session will immediately precede the SBT (\<2h). The intervention is administered before the SBT daily from the randomization to day 7 or until extubation.

BEHAVIORAL

Protocolized standard of care

The protocolized standard of care will consist in the description of authorized human/behavioral patient-nurse interactions and patient installation prior to the daily SBT.

Locations (5)

Hôpital de Fleyriat - Centre hospitalier de Bourg-en-Bresse - Réanimation Soins continus

Bourg-en-Bresse, France

CHU Clermont Ferrand - Hôpital Gabriel Montpied - Médecine Intensive Réanimation

Clermont-Ferrand, France

CHU Grenoble Alpes - Hôpital Michallon - Médecine Intensive Réanimation

La Tronche, France

Hospices Civils de Lyon - Hôpital de la Croix Rousse - Médecine Intensive Réanimation

Lyon, France

Hospices Civils de Lyon - Hôpital Lyon Sud - Réanimation Polyvalente

Pierre-Bénite, France