Effect of Hypnosis on Dyspnea (Hypnopnee)
Primary Purpose
Healthy, Dyspnea
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypnosis
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- pregnancy
- ongoing pain
- respiratory disease
- high levels of depression, panic disorder, or other significant mental health problems
- not fluent in french
Sites / Locations
- Service de Pneumologie et Réanimation Médicale
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hypnosis, visual distraction
Arm Description
This is a crossover study in which each subject will be exposed to a 5 min phase of hypnotic suggestion and visual distraction. For hypnotic suggestion, subject will be invited to experience a pleasant memory . Indirect and permissive suggestion will be used. For visual distraction, subject will be watching the movie "la marche des empereurs"
Outcomes
Primary Outcome Measures
Subject rating of Breathing Discomfort (affective component of dyspnea)
Subjects will rate breathing discomfort using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Subject rating of dyspnea intensity (sensory component of dyspnea)
Subjects will rate dyspnea intensity using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Secondary Outcome Measures
Full Information
NCT ID
NCT02792738
First Posted
May 31, 2016
Last Updated
September 12, 2019
Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
1. Study Identification
Unique Protocol Identification Number
NCT02792738
Brief Title
Effect of Hypnosis on Dyspnea
Acronym
Hypnopnee
Official Title
Effect of Hypnosis on Dyspnea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
September 13, 2016 (Actual)
Study Completion Date
September 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.
Detailed Description
This is a study of permissive suggestion in two laboratory models of dyspnea ("work/effort", "air hunger"). Breathing discomfort rating induced by laboratory models of dyspnea will be assessed before, during and after hypnosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Dyspnea
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypnosis, visual distraction
Arm Type
Experimental
Arm Description
This is a crossover study in which each subject will be exposed to a 5 min phase of hypnotic suggestion and visual distraction.
For hypnotic suggestion, subject will be invited to experience a pleasant memory . Indirect and permissive suggestion will be used.
For visual distraction, subject will be watching the movie "la marche des empereurs"
Intervention Type
Behavioral
Intervention Name(s)
hypnosis
Primary Outcome Measure Information:
Title
Subject rating of Breathing Discomfort (affective component of dyspnea)
Description
Subjects will rate breathing discomfort using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Time Frame
continuous measurement for 5 minutes
Title
Subject rating of dyspnea intensity (sensory component of dyspnea)
Description
Subjects will rate dyspnea intensity using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Time Frame
continuous measurement for 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
pregnancy
ongoing pain
respiratory disease
high levels of depression, panic disorder, or other significant mental health problems
not fluent in french
Facility Information:
Facility Name
Service de Pneumologie et Réanimation Médicale
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Hypnosis on Dyspnea
We'll reach out to this number within 24 hrs