Smoking CessationJe_RespireNCT04635358
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
A study testing Hypnosis, Psychological support and Nutrional support in people with Smoking Cessation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The recorded prevalence of daily smoking among health professionals (doctors, nurses, midwives, etc.), regardless of their mode of practice (salaried or self-employed, etc.) varies between 14 and 23%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Hypnosis, Psychological support and Nutrional support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2020to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Professionals employed at the Nice hospital who are volunteers and have :
- an initial Fagerstrom test > 3
- associated with expired carbone monoxide > 10 ppm at least 60' after the last cigarette.
Who cannot join
- Reported associated addiction (cannabis, alcohol or any other psychoactive product)
- Professionals likely to no longer work at the Nice Hospital in the year following the start of the study
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Smoking Cessation for the Staff of a Hospital Center Through a Treatment Proposal Combining Nicotine Substitutes, Psychological Support, Nutritional Assistance and Hypnosis.
The recorded prevalence of daily smoking among health professionals (doctors, nurses, midwives, etc.), regardless of their mode of practice (salaried or self-employed, etc.) varies between 14 and 23%. In health care institutions, according to the studies, the prevalence of daily smoking among staff, caregivers and non-caregivers ranges from 17% to 27%. These professionals who continue to smoke, although they are particularly well informed about the risks they run, probably constitute a group with specific withdrawal difficulties. Beyond the impact on their own health, the smoking status of caregivers could also have an impact on the management of tobacco patients. There are very few studies of the impact of interventions on the smoking status of caregivers in health care facilities. The combination of several intervention modalities can facilitate the participation of target professionals and generate efficiency synergies.
- Conditions
- Smoking Cessation
- Being tested
- Hypnosis, Psychological support, Nutrional support
- Keywords
- Smoking, hypnosis, nutrition support, psychological support
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
Setting up hypnosis sessions
Psychological supportBehavioural
Setting up psychological support
Nutrional supportBehavioural
Setting up nutritional support
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Setting up hypnosis sessions, psychological and nutritional assistance. Receives: Behavioral: Hypnosis; Behavioral: Psychological support; Behavioral: Nutrional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects enrolled in the program who participated in the full range of care offered
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start21 Sep 2020
- Primary completion21 Jul 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard PROUVOST-KELLER, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635358
- Sponsor's protocol ID
- 19-PP-16
- Acronym
- Je_Respire
- Status last verified
- Jan 2024
- First submitted
- 13 Nov 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Smoking Cessation for the Staff of a Hospital Center Through a Treatment Proposal Combining Nicotine Substitutes, Psychological Support, Nutritional Assistance and Hypnosis.
- ClinicalTrials.gov ID
- NCT04635358
- Acronym / sponsor ID
- Je_Respire / 19-PP-16
- Conditions
- Smoking Cessation
- Keywords
- Smoking, hypnosis, nutrition support, psychological support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The recorded prevalence of daily smoking among health professionals (doctors, nurses, midwives, etc.), regardless of their mode of practice (salaried or self-employed, etc.) varies between 14 and 23%. In health care institutions, according to the studies, the prevalence of daily smoking among staff, caregivers and non-caregivers ranges from 17% to 27%. These professionals who continue to smoke, although they are particularly well informed about the risks they run, probably constitute a group with specific withdrawal difficulties. Beyond the impact on their own health, the smoking status of caregivers could also have an impact on the management of tobacco patients. There are very few studies of the impact of interventions on the smoking status of caregivers in health care facilities. The combination of several intervention modalities can facilitate the participation of target professionals and generate efficiency synergies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Hypnosis, Behavioral: Psychological support, Behavioral: Nutrional supportSetting up hypnosis sessions, psychological and nutritional assistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- an initial Fagerstrom test > 3
- associated with expired carbone monoxide > 10 ppm at least 60' after the last cigarette.
Key exclusion criteria (3 listed)
- Reported associated addiction (cannabis, alcohol or any other psychoactive product)
- Professionals likely to no longer work at the Nice Hospital in the year following the start of the study
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisSetting up hypnosis sessions | Behavioural | Intervention |
| Psychological supportSetting up psychological support | Behavioural | Intervention |
| Nutrional supportSetting up nutritional support | Behavioural | Intervention |
Primary outcome
Number of subjects enrolled in the program who participated in the full range of care offered
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard PROUVOST-KELLER, Dr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis, Psychological support and Nutrional support in people with Smoking Cessation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects enrolled in the program who participated in the full range of care offered (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.