Psychological impact of shortness of breath
| ISRCTN | ISRCTN16300079 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16300079 |
| Secondary identifying numbers | PSYCHOPNEA |
- Submission date
- 23/03/2018
- Registration date
- 09/04/2018
- Last edited
- 22/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Dyspnea (shortness of breath) is an unpleasant defining symptom in various diseases including respiratory, cardiac, cancer-related, neuromuscular and psychological disorders, and is highly common in the general population. It is frequently associated with low mood, severe suffering, limited quality of life, high socioeconomic costs and even increased mortality risk. The physical pathways of dyspnea are partly unknown. Inducing dyspnea in healthy subjects in a controlled, laboratory situation (experimental dyspnea) is a common approach to understand the mechanisms of dyspnea and to describe its impact on various bodily functions. Little attention has been paid to the possible unwanted psychological impact of experimental dyspnea in subjects participating in experiments. It is possible that subjects exposed to experimental dyspnea could experience acute suffering that would be out of proportion with the value of the scientific information sought for by the study (therefore questioning the ethical balance of the research). This risk does not seem to have been specifically assessed previously.
The present study aims to test whether healthy volunteers could develop psychological changes related to post-traumatic stress. If this is true, the study also aims to find out whether this situation can be predicted through certain personal characteristics.
Who can participate?
Healthy adult volunteers who already take part in a laboratory-induced dyspnea experiment.
What does the study involve?
Participants will fill in questionnaires just before, and just after the laboratory-induced dyspnea experiment, as well as a structured interview 7 days after the last experiment and an online questionnaire 3 months after the experiment to assess the presence of post-traumatic stress syndrome.
What are the possible benefits and risks of participating?
The protocol is based on the free participation of healthy subjects. The procedure used has no risk to physical health, and the purpose of this study is to determine whether there are possible psychological consequences.
Where is the study run from?
The study will be conducted at the physiopathology respiratory laboratory of the hospital Pitié-Salpêtrière (Paris, France)
When is the study starting and how long is it expected to run for?
Start date : 01/05/2018 for 3 years
Who is funding the study?
There is no funding for this study
Who is the main contact?
Sophie Lavault, PhD
sophie.lavault@aphp.fr
Contact information
Public
Service de Pneumologie et Réanimation médicale
GH Pitié-Salpêtrière
Paris
75013
France
Study information
| Study design | Longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Psychological impact of experimental dyspnea in healthy subjects and its determinants |
| Study acronym | PSYCHOPNEA |
| Study objectives | Healthy volunteers could develop a post-traumatic stress disorder after experimental dyspnea. |
| Ethics approval(s) | Evaluation ongoing at the CPP Sud-Est III (France), submitted 21/03/2018 |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder induced by dyspnea |
| Intervention | Current intervention as of 30/12/2021: Experimental induced dyspnea and questionnaires (mood and psychological aspects) Observational study : - duration of participation for a subject : 3 months - duration of the study : 3 years - each participant will experiment 2 types of induced dyspnea (2 visits are necessary). Healthy volunteers who are participating in other studies involving experimental dyspnea (ethical approval already obtained) will complete some questionnaires before and after the experimental dyspnea to assess the psychological dimension of this kind of experimentation. 1 week after the second experiment participants will have structured interview with the psychologist (for qualitative analysis and 3 months after the second experiment participants will have an online questionnaire to assess the presence of post-traumatic stress syndrome. _____ Previous intervention: Experimental induced dyspnea and questionnaires (mood and psychological aspects) Observational study : - duration of participation for a subject : 1 month - duration of the study : 3 years - each participant will experiment 2 types of induced dyspnea (2 visits are necessary). Healthy volunteers who are participating in other studies involving experimental dyspnea (ethical approval already obtained) will complete some questionnaires before and after the experimental dyspnea to assess the psychological dimension of this kind of experimentation. (added 30/09/2020) 1 week after the second experiment participants will have a semi-structured interview with the psychologist (for qualitative analysis) |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 30/12/2021: Presence of post-traumatic stress disorder, assessed with the validated French version of the PCL-5 questionnaire (score >38), 3 months after the experiment _____ Previous primary outcome measure: Presence of post-traumatic stress disorder, assessed with the validated French version of the PCL-5 questionnaire (score >38), 4 weeks after the experiment. |
| Secondary outcome measures | 1. Change in "state anxiety" (STAI A questionnaire) compared with baseline (online, 1 week and 4 weeks after the experiment) 2. Correlation between score using Peritraumatic Distress Inventory (PDI) and score using PCL-5, 4 weeks after the experiment (added 30/09/2020) 3. Persistence of a psychological impact (bad memories, negative emotions, nightmares) 7 days after the last experiment using a semi-structured interview |
| Overall study start date | 01/03/2018 |
| Completion date | 14/04/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Aged 18 years or over |
| Key exclusion criteria | 1. Pregnant 2. Protected adult 3. Person deprived of liberty 4. Existing respiratory pathology 5. Existence of any chronic pathology identified and subject to treatment, including psychiatric disorders 6. Absence of affiliation to social security 7. Vulnerable |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 14/03/2021 |
Locations
Countries of recruitment
- France
Study participating centre
Paris
75013
France
Sponsor information
Other
ADOREPS
Service de Pneumologie et Réanimation médicale
Bâtiment Montyon, 2ème étage
GH Pitié-Salpêtrière
47-83, boulevard de l'hôpital
Paris
75013
France
Funders
Funder type
Not defined
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- ADOREPS
- Location
- France
Results and Publications
| Intention to publish date | 14/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
22/04/2022: The intention to publish date has been changed from 14/04/2022 to 14/04/2023.
30/12/2021: The following changes have been made:
1. The intervention has been changed.
2. The primary outcome measure has been changed.
3. The plain English summary has been updated to reflect these changes.
30/09/2020: The following changes were made to the trial record:
1. The interventions were changed.
2. The secondary outcome measures were changed.
