HypnosisHypnoMedInNCT04698824
Hypnosis in Internal Medecine
An observational study of Hypnosis and Autoimmune Diseases, run by University Hospital, Grenoble.
Trial summary
Description of the short and long-term impact of hypnosis sessions for patient having benefited from at least one hypnosis session in internal medicine at the french hospital "Groupe Hospitalier Mutualiste de Grenoble", with the help of a qualitative survey made by phone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypnosis, Autoimmune Diseases, Medically Unexplained Symptoms
- What is being tested?
- Hypnosis session
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Oct 2021
- Phase
- Observational
- 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
Study population: All consecutive patients who had at least one hypnosis session in internal medicine at the hospital "Groupe Hospitalier Mutualiste de Grenoble" between 08/28/2015 (date of the very first hypnosis consultation in internal medicine) and 03/17/2020 (date of confinement due to Covid19 in France)
Who may be able to join
- All consecutive patients who had at least one hypnosis session in internal medicine at the hospital "Groupe Hospitalier Mutualiste de Grenoble" between 08/28/2015 (date of the very first hypnosis consultation in internal medicine) and 03/17/2020 (date of confinement due to Covid19 in France)
Who cannot join
- Patient who had a hypnosis session, but who is not followed for a pathology in internal medicine or in internal medicine with a pneumological orientation
Trial locations and contacts
No sites are listed yet.
Mélanie ARNAUD contact
About this study
Official title: Hypnose en médecine Interne
Description of the short and long-term impact of hypnosis sessions for patient having benefited from at least one hypnosis session in internal medicine at the french hospital "Groupe Hospitalier Mutualiste de Grenoble", with the help of a qualitative survey made by phone.
Read the detailed description
The practice of hypnosis has experienced a recent boom in medicine, with a multiplication of its fields of action. Regarding internal medicine, the influence of the psyche on the immune system makes the use of hypnosis particularly relevant for autoimmune diseases. Medically unexplained symptoms (another important field of internal medicine) are also strongly psychosomatic and thus susceptible to hypnosis. The hypothesis is thus made that hypnosis can bring multiple benefits to internal medicine patients.
The main objective of this study is to describe the short and long-term impact of hypnosis sessions for patient having benefited from at least one hypnosis session in internal medicine at the french hospital "Groupe Hospitalier Mutualiste de Grenoble", with the help of a qualitative survey made by phone.
Moreover retrospective medical data concerning these patients will be collected to determine their medical history, their main symptoms et reasons to use hypnosis.
- Being tested
- Hypnosis session
- Keywords
- internal medicine, survey, qualitative, impact of hypnosis
- Medical subject headings
- Autoimmune Diseases, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis sessionProcedure or surgery
At least one session of hypnosis in the internal medicine unit at the hospital "Groupe Hospitalier Mutualiste de Grenoble"
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the short and long-term impact of hypnosis sessions thanks to a qualitative phone survey
Improvement in symptoms and quality of life, assessed thanks to a qualitative phone survey by 5-levels Likert scales
Measured: Assessed only once. Phone call will be performed between march 2021 and June 2021
Secondary outcomes (2)
Assessment of the reasons for patient satisfaction / dissatisfaction
Qualitative description by an open question in the phone survey
Measured: Assessed only once. Phone call will be performed between march 2021 and June 2021
Description of the characteristics of these patients and of the hypnosis sessions
Patients'characteristics described in medical records
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study startJun 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypnosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Mutualiste de Grenoble
- Responsible party
- Sponsor
- Investigators
- Maxime LUGOSI, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698824
- Sponsor's protocol ID
- 2020-A03469-30
- Acronym
- HypnoMedIn
- Status last verified
- May 2021
- First submitted
- 4 Jan 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lugosi M, Sacre K, Lidove O, Chauveheid MP, Brihaye B, Laissy JP, Chauchard M, Papo T. [Long-term follow-up of a French cohort of retroperitoneal fibrosis]. Rev Med Interne. 2013 Oct;34(10):591-9. doi: 10.1016/j.revmed.2013.02.002. Epub 2013 Mar 14. French.
PubMed 23498668Lugosi M, Alberti C, Zahar JR, Garrouste M, Lemiale V, Descorps-Desclere A, Ricard JD, Goldgran-Toledano D, Cohen Y, Schwebel C, Vesin A, Timsit JF, Azoulay E. Aspergillus in the lower respiratory tract of immunocompetent critically ill patients. J Infect. 2014 Sep;69(3):284-92. doi: 10.1016/j.jinf.2014.04.010. Epub 2014 Jun 9.
PubMed 24924557Tolsma V, Schwebel C, Azoulay E, Darmon M, Souweine B, Vesin A, Goldgran-Toledano D, Lugosi M, Jamali S, Cheval C, Adrie C, Kallel H, Descorps-Declere A, Garrouste-Orgeas M, Bouadma L, Timsit JF. Sepsis severe or septic shock: outcome according to immune status and immunodeficiency profile. Chest. 2014 Nov;146(5):1205-1213. doi: 10.1378/chest.13-2618.
PubMed 25033349Gunther SC, Schwebel C, Hamidfar-Roy R, Bonadona A, Lugosi M, Ara-Somohano C, Minet C, Potton L, Cartier JC, Vesin A, Chautemps M, Styfalova L, Ruckly S, Timsit JF. Complications of intravascular catheters in ICU: definitions, incidence and severity. A randomized controlled trial comparing usual transparent dressings versus new-generation dressings (the ADVANCED study). Intensive Care Med. 2016 Nov;42(11):1753-1765. doi: 10.1007/s00134-016-4582-2. Epub 2016 Oct 12.
PubMed 27734108
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnose en médecine Interne
- ClinicalTrials.gov ID
- NCT04698824
- Acronym / sponsor ID
- HypnoMedIn / 2020-A03469-30
- Keywords
- internal medicine, survey, qualitative, impact of hypnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Mutualiste de Grenoble
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 7 Jan 2021 (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.
Description of the short and long-term impact of hypnosis sessions for patient having benefited from at least one hypnosis session in internal medicine at the french hospital "Groupe Hospitalier Mutualiste de Grenoble", with the help of a qualitative survey made by phone.
Detailed description
The practice of hypnosis has experienced a recent boom in medicine, with a multiplication of its fields of action. Regarding internal medicine, the influence of the psyche on the immune system makes the use of hypnosis particularly relevant for autoimmune diseases. Medically unexplained symptoms (another important field of internal medicine) are also strongly psychosomatic and thus susceptible to hypnosis. The hypothesis is thus made that hypnosis can bring multiple benefits to internal medicine patients.
The main objective of this study is to describe the short and long-term impact of hypnosis sessions for patient having benefited from at least one hypnosis session in internal medicine at the french hospital "Groupe Hospitalier Mutualiste de Grenoble", with the help of a qualitative survey made by phone.
Moreover retrospective medical data concerning these patients will be collected to determine their medical history, their main symptoms et reasons to use hypnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who had at least one hypnosis session in internal medicine at the hospital "Groupe Hospitalier Mutualiste de Grenoble" between 08/28/2015 (date of the very first hypnosis consultation in internal medicine) and 03/17/2020 (date of confinement due to Covid19 in France)
Key inclusion criteria (1 listed)
- All consecutive patients who had at least one hypnosis session in internal medicine at the hospital "Groupe Hospitalier Mutualiste de Grenoble" between 08/28/2015 (date of the very first hypnosis consultation in internal medicine) and 03/17/2020 (date of confinement due to Covid19 in France)
Key exclusion criteria (1 listed)
- Patient who had a hypnosis session, but who is not followed for a pathology in internal medicine or in internal medicine with a pneumological orientation
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 |
|---|---|---|
| Hypnosis sessionAt least one session of hypnosis in the internal medicine unit at the hospital "Groupe Hospitalier Mutualiste de Grenoble" | Procedure or surgery | – |
Primary outcome
Description of the short and long-term impact of hypnosis sessions thanks to a qualitative phone survey
Time frame: Assessed only once. Phone call will be performed between march 2021 and June 2021
Improvement in symptoms and quality of life, assessed thanks to a qualitative phone survey by 5-levels Likert scales
2 secondary outcomes
Assessment of the reasons for patient satisfaction / dissatisfaction
Time frame: Assessed only once. Phone call will be performed between march 2021 and June 2021
Description of the characteristics of these patients and of the hypnosis sessions
Time frame: At inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 23498668Lugosi M, Sacre K, Lidove O, Chauveheid MP, Brihaye B, Laissy JP, Chauchard M, Papo T. [Long-term follow-up of a French cohort of retroperitoneal fibrosis]. Rev Med Interne. 2013 Oct;34(10):591-9. doi: 10.1016/j.revmed.2013.02.002. Epub 2013 Mar 14. French.
- Background: PubMed 24924557Lugosi M, Alberti C, Zahar JR, Garrouste M, Lemiale V, Descorps-Desclere A, Ricard JD, Goldgran-Toledano D, Cohen Y, Schwebel C, Vesin A, Timsit JF, Azoulay E. Aspergillus in the lower respiratory tract of immunocompetent critically ill patients. J Infect. 2014 Sep;69(3):284-92. doi: 10.1016/j.jinf.2014.04.010. Epub 2014 Jun 9.
- Background: PubMed 25033349Tolsma V, Schwebel C, Azoulay E, Darmon M, Souweine B, Vesin A, Goldgran-Toledano D, Lugosi M, Jamali S, Cheval C, Adrie C, Kallel H, Descorps-Declere A, Garrouste-Orgeas M, Bouadma L, Timsit JF. Sepsis severe or septic shock: outcome according to immune status and immunodeficiency profile. Chest. 2014 Nov;146(5):1205-1213. doi: 10.1378/chest.13-2618.
- Background: PubMed 27734108Gunther SC, Schwebel C, Hamidfar-Roy R, Bonadona A, Lugosi M, Ara-Somohano C, Minet C, Potton L, Cartier JC, Vesin A, Chautemps M, Styfalova L, Ruckly S, Timsit JF. Complications of intravascular catheters in ICU: definitions, incidence and severity. A randomized controlled trial comparing usual transparent dressings versus new-generation dressings (the ADVANCED study). Intensive Care Med. 2016 Nov;42(11):1753-1765. doi: 10.1007/s00134-016-4582-2. Epub 2016 Oct 12.
- 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.
Mélanie ARNAUD contact
Maxime LUGOSI, PhD principal investigator
CHU Grenoble Alpes
Questions about this trial
What is this clinical trial studying?
An observational study of Hypnosis and Autoimmune Diseases, run by University Hospital, Grenoble.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime LUGOSI, PhD (04 76 76 37 07, mlugosi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the short and long-term impact of hypnosis sessions thanks to a qualitative phone survey (time frame: Assessed only once. Phone call will be performed between march 2021 and June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04698824, which also lists 4 linked publications.
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 5 May 2021.