Lung DiseasesAUTOHYPNOSE-TPNCT02216539
Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation
A study testing Self-hypnosis, Lung transplantation and Standard post-operative pain management in people with Lung Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Self-hypnosis, Lung transplantation and Standard post-operative pain management
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Dec 2014
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients over 15 years of age
- indication of lung transplantation
Who cannot join
- patient unable to receive training in self-hypnosis (for cognitive, linguistic or cultural reasons)
Trial locations and contacts
1 site in 1 country.
About this study
Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.
The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.
- Conditions
- Lung Diseases
- Being tested
- Self-hypnosis, Lung transplantation, Standard post-operative pain management
- Keywords
- All terminal, leading, indication, lung transplantation
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosisBehavioural
Patients will be trained to self-hypnosis prior to surgery, in order to be able to use self-hypnosis as a pain-management tool after surgery
Lung transplantationProcedure or surgery
Standard post-operative pain managementOther
Post-operative pain management treatments as per usual protocols in the hospital
| Study group | Role | What they receive |
|---|---|---|
| Self-hypnosis | Experimental | Patients trained to self-hypnosis before surgery Receives: Behavioral: Self-hypnosis; Procedure: Lung transplantation; Other: Standard post-operative pain management |
| Usual pain management | Active comparator | Patients receiving the usual post-operative pain management protocols Receives: Procedure: Lung transplantation; Other: Standard post-operative pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Score (Visual Analog Scale) One Month After Surgery
Average level of pain (scored by the patient on a visual analog scale), during the 48 hours preceding the scheduled consultation at one month post-surgery
Measured: one month after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
Why it stopped: Change of sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hôpital Foch, Suresnes, FranceMarc Fischler, MD, Study chair, Hôpital Foch, Suresnes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216539
- Sponsor's protocol ID
- 2014-A00538-39
- Acronym
- AUTOHYPNOSE-TP
- Status last verified
- May 2016
- First submitted
- 13 Aug 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation
- ClinicalTrials.gov ID
- NCT02216539
- Acronym / sponsor ID
- AUTOHYPNOSE-TP / 2014-A00538-39
- Conditions
- Lung Diseases
- Keywords
- All terminal, leading, indication, lung transplantation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of sponsor
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- First posted
- 15 Aug 2014 (estimated)
- 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.
Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.
The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis | Experimental | Behavioral: Self-hypnosis, Procedure: Lung transplantation, Other: Standard post-operative pain managementPatients trained to self-hypnosis before surgery |
| Usual pain management | Active comparator | Procedure: Lung transplantation, Other: Standard post-operative pain managementPatients receiving the usual post-operative pain management protocols |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 15 years of age
- indication of lung transplantation
Key exclusion criteria (1 listed)
- patient unable to receive training in self-hypnosis (for cognitive, linguistic or cultural reasons)
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 |
|---|---|---|
| Self-hypnosisPatients will be trained to self-hypnosis prior to surgery, in order to be able to use self-hypnosis as a pain-management tool after surgery | Behavioural | Self-hypnosis |
| Lung transplantation | Procedure or surgery | Self-hypnosis, Usual pain management |
| Standard post-operative pain managementPost-operative pain management treatments as per usual protocols in the hospital | Other | Self-hypnosis, Usual pain management |
Primary outcome
Average Pain Score (Visual Analog Scale) One Month After Surgery
Time frame: one month after transplantation
Average level of pain (scored by the patient on a visual analog scale), during the 48 hours preceding the scheduled consultation at one month post-surgery
Results and safety
The study was stopped early (reason given: Change of sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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.
Mireille Michel-Cherqui, MD principal investigator
Hôpital Foch, Suresnes, France
Marc Fischler, MD study chair
Hôpital Foch, Suresnes, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnosis, Lung transplantation and Standard post-operative pain management in people with Lung Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild 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 2 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: stopped early, as of the sponsor's last update on 13 May 2016. 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 was stopped early (reason given: Change of sponsor). Results are not available in the source record.
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?
Average Pain Score (Visual Analog Scale) One Month After Surgery (time frame: one month after transplantation). 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 13 May 2016.