Interest of Hypnosis When Setting up Non-invasive Ventilation in a Conscious Patient With COPD and/or Obesity With a BMI Greater Than 30, Suffering Fromacute Respiratory Distress in Adult Intensive Care

NCT04220463 | Recruiting

• 3 other identifiers: 35RC19_9747_HYVIR2019-A02238-4919/08/14/42258
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Discomfort during respiratory decompensation of a patient with chronic obstructive pulmonary disease (COPD) and/or obesity with a BMI greater than 30, in intensive care and the establishment of non-invasive ventilation (NIV) is frequent and a source of failure. this therapy. Pharmacological treatments may be impossible due to the pathology, the risk of it worsening and adverse effects. In this context, hypnosis appears to be a tool that would promote comfort and thus increase tolerance of NIV.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Obesity With a BMI Greater Than 30; Acute Respiratory Distress in Adult Intensive Care

Outcome Measures

Primary Outcomes (1)

• Comfort

  Quantification of comfort by a Digital Verbal Comfort Scale 2 hours after initiation of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)

  2 hours after initiation of NIV

Secondary Outcomes (10)

• Anxiety

  Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV

• First NIV session duration

  At the end of the first NIV session

• Comfort

  Before and 30 minuts and 24 hours after the implementation of the NIV

• TcpCO2

  Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV

• NIV duration

  after the first 24 hours of treatment

Study Arms (2)

Hypnosis group

EXPERIMENTAL

For the hypnosis group, hypnotic support is set up by a doctor/IDE previously trained and dedicated during the implementation of the NIV. The dedicated doctor/IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated doctor/IDE.

Other: Hypnosis + NIV

Control group

PLACEBO COMPARATOR

In the control group, in order to preserve the knowledge of the evaluator, the doctor/IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service.

Other: NIV

Interventions

Hypnosis + NIV OTHER

For the hypnosis group, hypnotic support is set up by a doctor/IDE previously trained and dedicated during the implementation of the NIV. The dedicated doctor/IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated doctor/IDE.

Hypnosis group

NIV OTHER

In the control group, in order to preserve the knowledge of the evaluator, the doctor/IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service.

Control group

Eligibility Criteria

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

You may qualify if:

• Man or woman, aged 18 or over, admitted to medical intensive care
• Glasgow score = 15
• Patient with acute respiratory failure decompensating COPD and/or having obesity with a body mass index (BMI) greater than 30
• Patient having given free, informed and written consent
• Patient affiliated to a health insurance system
• Glasgow score = 15
• Need during use of non-invasive ventilation

You may not qualify if:

• Procedure to be carried out in extreme urgency (PaCO2 too high and leading to an immediate vital risk, and / or PaO2 too low) on medical decision
• Confusional state making hypnosis impossible
• Decompensated psychiatric illness
• Patient entering with an NIV in place already installed in another department. The subject becomes included again at the end of the treatment with NIV if however he needs it again.
• Patient already included in the study during previous non-invasive ventilation
• Patient participating in research involving an interventional human person (category 1) on an analgesic / sedative medication
• A person of full age subject to legal protection (safeguard of justice, curators, guardianship) or deprived of liberty

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Hypnosis; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patient randomization will be done online. SETTING UP AND MAINTAINING THE INSU People having knowledge of the randomization group * Doctor in charge of the patient * Doctor/IDE dedicated to hypnosis (present throughout the procedure, regardless of the randomization group) * Patient People not having knowledge of the randomization group * assessor = other IDE or doctor not directly taking care of the patient assessor present at 4 times: inclusion, H0, H2 and H24 but absent during the procedure 1 single assessor for the 4 times of the same patient
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective monocentric, controlled, randomized, superiority, open study with a blind assessor, on two parallel groups.

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 7, 2020
• Study Start: November 20, 2021
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)