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Effect of Hypnosis on Dyspnea (Hypnopnee)

Primary Purpose

Healthy, Dyspnea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypnosis
Sponsored by
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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
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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

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Effect of Hypnosis on Dyspnea

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