Brief Summary

The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2016

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

May 31, 2016

Last Update Submit

September 12, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    continuous measurement for 5 minutes

  • 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).

    continuous measurement for 5 minutes

Study Arms (1)

hypnosis, visual distraction

EXPERIMENTAL

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"

Behavioral: hypnosis

Interventions

hypnosisBEHAVIORAL
hypnosis, visual distraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • pregnancy
  • ongoing pain
  • respiratory disease
  • high levels of depression, panic disorder, or other significant mental health problems
  • not fluent in french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie et Réanimation Médicale

Paris, 75013, France

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 8, 2016

Study Start

May 23, 2016

Primary Completion

September 13, 2016

Study Completion

September 13, 2016

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations