Breast CancerHYPNOSEINNCT03253159
Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery
A study testing Hypnosis in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypnosis
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to 22 Feb 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female > 18 years
- Patient with ASA* score 1, 2, 3
- Minor Unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary node dissection, minor breast reconstruction…)
- Day case surgery (ambulatory surgery - living Day0-Day1)
- General anesthesia required
- Written informed consent
- French medical benefit
Who cannot join
- Age < 18 years
- Patient with ASA score > 4;
- Body mass index < 15 or 45kg/T;
- Major Surgery indication : mastectomy, bilateral surgery, full axillary dissection, major breast reconstruction
- Patient refusing hypnosis
- Psychic or mental Disorders
Show all 11Show fewer
- Chronic pain
- Opiate therapeutic > 3 months
- Not ability to speak and read French language
- Deaf and dumb patient
- Under guardianship patient or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)
Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
Read the detailed description
Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to alleviate patient anxiety. However, alternative techniques, additional non-pharmacological, have proven effective in alleviating pain and anxiety perioperative. These techniques are retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a technique of choice. Regarding medical hypnosis techniques, many studies have shown that performing a hypnotic technique performed perioperative could reduce the doses of anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a number of postoperative adverse effects.
Among the various techniques of hypnosis that can be offered to patients in the perioperative, conversational hypnosis is to accompany the patient on admission to the block to realization of general anesthesia. This technique aims to suggest a pleasant environment and not anxiety.
This study evaluate the impact of this support in reducing postoperative major adverse effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
- Conditions
- Breast Cancer
- Being tested
- Hypnosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis group | Experimental | The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room Receives: Behavioral: Hypnosis |
| Control group | No intervention | No special preparation before intravenous general anesthesia induction in the operative room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain scale
Pain intensity assessment
Measured: through study completion, an average of 5 year
Secondary outcomes (1)
Reduction of the pain using Visual Analogic Scale
Reduction of the pain adverse postoperative outcome:
Using Visual Analogic Scale (VAS > 3/10)
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startSep 2014
- Primary completionSep 2016
- Study completion22 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jibba AMRAOUI, Study chair, Institut régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253159
- Sponsor's protocol ID
- ICM-URC-2014/30
- Acronym
- HYPNOSEIN
- Status last verified
- Aug 2020
- First submitted
- 29 Aug 2016
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.
PubMed 30646110
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)
- ClinicalTrials.gov ID
- NCT03253159
- Acronym / sponsor ID
- HYPNOSEIN / ICM-URC-2014/30
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 22 Feb 2017 (actual)
- First posted
- 17 Aug 2017 (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.
Evaluate the impact of the support in reducing postoperative adverse events in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
Detailed description
Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to alleviate patient anxiety. However, alternative techniques, additional non-pharmacological, have proven effective in alleviating pain and anxiety perioperative. These techniques are retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a technique of choice. Regarding medical hypnosis techniques, many studies have shown that performing a hypnotic technique performed perioperative could reduce the doses of anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a number of postoperative adverse effects.
Among the various techniques of hypnosis that can be offered to patients in the perioperative, conversational hypnosis is to accompany the patient on admission to the block to realization of general anesthesia. This technique aims to suggest a pleasant environment and not anxiety.
This study evaluate the impact of this support in reducing postoperative major adverse effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia
| Arm | Type | Receives |
|---|---|---|
| Hypnosis group | Experimental | Behavioral: HypnosisThe conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room |
| Control group | No intervention | –No special preparation before intravenous general anesthesia induction in the operative room |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female > 18 years
- Patient with ASA* score 1, 2, 3
- Minor Unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary node dissection, minor breast reconstruction…)
- Day case surgery (ambulatory surgery - living Day0-Day1)
- General anesthesia required
Key exclusion criteria (11 listed)
- Age < 18 years
- Patient with ASA score > 4;
- Body mass index < 15 or 45kg/T;
- Major Surgery indication : mastectomy, bilateral surgery, full axillary dissection, major breast reconstruction
- Patient refusing hypnosis
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 |
|---|---|---|
| HypnosisThe conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room. | Behavioural | Hypnosis group |
Primary outcome
Assessment of pain scale
Time frame: through study completion, an average of 5 year
Pain intensity assessment
1 secondary outcome
Reduction of the pain using Visual Analogic Scale
Time frame: through study completion, an average of 5 year
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 10 Aug 2020.
- Derived from this study: PubMed 30646110Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.
- 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.
jibba AMRAOUI study chair
Institut régional du Cancer de Montpellier
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 in people with Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 7 inclusion and 11 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 10 Aug 2020. 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?
Assessment of pain scale (time frame: through study completion, an average of 5 year). 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 NCT03253159, which also lists 1 linked publication.
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 10 Aug 2020.