Breast Neoplasm FemaleNCT05027321
Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies
A study testing Preparation in Self-Hypnosis by anchoring, Conversational Hypnosis and Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis in people with Breast Neoplasm Female, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
The incidence of breast cancer and its mortality are reduced thanks in particular to early detection. Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Preparation in Self-Hypnosis by anchoring, Conversational Hypnosis and Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2022to Jan 2025
- 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
- aged 18 or over,
- referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy,
- naive of any hypnosis,
- having given free, informed and written consent,
- being affiliated to a social security scheme or beneficiary of such scheme
Who cannot join
- having a major hearing loss,
- suffering from identified mental or psychotic disorders,
- not understanding the French language,
- having already had hypnosis practices,
- having an ongoing pregnancy,
- being the subject of a safeguard measure
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Joseph
Marseille
Vanessa MILIEN
About this study
Official title: Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies: a Randomized Study
The incidence of breast cancer and its mortality are reduced thanks in particular to early detection.
Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act.
Read more
Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination.
Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management.
However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.
- Conditions
- Breast Neoplasm Female
- Being tested
- Preparation in Self-Hypnosis by anchoring, Conversational Hypnosis, Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparation in Self-Hypnosis by anchoringBehavioural
Preparation in Self-Hypnosis by anchoring just before examination
Conversational HypnosisBehavioural
Conversational Hypnosis during examination
Preparation in Self-Hypnosis by anchoring + Conversational HypnosisBehavioural
Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | control |
| Preparation in Self-Hypnosis by anchoring | Experimental | 1-hour consultation with a hypnopractor just before the examination Receives: Behavioral: Preparation in Self-Hypnosis by anchoring |
| Conversational Hypnosis | Experimental | conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained Receives: Behavioral: Conversational Hypnosis |
| Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis | Experimental | 1-hour consultation with a hypnopractor just before the examination and conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained Receives: Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in anxiety score
Score (from 20 to 80) measured on the State-Trait Anxiety Inventory for state anxiety (STAI-Y1), how respondent feels right now, at this moment.
Total scores can be categorized into five levels:
- > 65 (very high),
- from 56 to 65 (high),
- from 46 to 55 (medium),
- from 36 to 45 (low),
- < 35 (very low). Higher scores mean a worse outcome.
Measured: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
Secondary outcomes (8)
change in anxiety score
measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)
Measured: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
change in pain score
measured on pain visual analog scale from 0 (no pain) to 10 (worst pain)
Measured: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
patient examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
Measured: baseline (immediately after the intervention)
staff examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
Measured: baseline (immediately after the intervention)
anxiety score
STAI-Y2 (score from 20 to 80 measured on the STAI for trait anxiety), how respondent generally feel
Total scores can be categorized into five levels:
- > 65 (very high),
- from 56 to 65 (high),
- from 46 to 55 (medium),
- from 36 to 45 (low),
- < 35 (very low). Higher scores mean a worse outcome.
Measured: baseline (pre-intervention)
Amount of nesthetic administered to the patiet during the procedure
mL
Measured: baseline (immediately after the intervention)
Examination duration
minutes
Measured: baseline (immediately after the intervention)
AE/SAE reporting
Measured: baseline (during the intervention, immediatly after the intervetion) and at 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start11 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027321
- Sponsor's protocol ID
- HYACOM
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies: a Randomized Study
- ClinicalTrials.gov ID
- NCT05027321
- Acronym / sponsor ID
- HYACOM
- Conditions
- Breast Neoplasm Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 30 Aug 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.
The incidence of breast cancer and its mortality are reduced thanks in particular to early detection.
Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act.
Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination.
Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management.
However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –control |
| Preparation in Self-Hypnosis by anchoring | Experimental | Behavioral: Preparation in Self-Hypnosis by anchoring1-hour consultation with a hypnopractor just before the examination |
| Conversational Hypnosis | Experimental | Behavioral: Conversational Hypnosisconversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained |
| Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis | Experimental | Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis1-hour consultation with a hypnopractor just before the examination and conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 or over,
- referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy,
- naive of any hypnosis,
- having given free, informed and written consent,
- being affiliated to a social security scheme or beneficiary of such scheme
Key exclusion criteria (6 listed)
- having a major hearing loss,
- suffering from identified mental or psychotic disorders,
- not understanding the French language,
- having already had hypnosis practices,
- having an ongoing pregnancy,
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 |
|---|---|---|
| Preparation in Self-Hypnosis by anchoringPreparation in Self-Hypnosis by anchoring just before examination | Behavioural | Preparation in Self-Hypnosis by anchoring |
| Conversational HypnosisConversational Hypnosis during examination | Behavioural | Conversational Hypnosis |
| Preparation in Self-Hypnosis by anchoring + Conversational HypnosisPreparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination | Behavioural | Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis |
Primary outcome
change in anxiety score
Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
Score (from 20 to 80) measured on the State-Trait Anxiety Inventory for state anxiety (STAI-Y1), how respondent feels right now, at this moment. Total scores can be categorized into five levels: 1. > 65 (very high), 2. from 56 to 65 (high), 3. from 46 to 55 (medium), 4. from 36 to 45 (low), 5. < 35 (very low). Higher scores mean a worse outcome.
8 secondary outcomes
change in anxiety score
Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
change in pain score
Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
patient examination experience
Time frame: baseline (immediately after the intervention)
staff examination experience
Time frame: baseline (immediately after the intervention)
anxiety score
Time frame: baseline (pre-intervention)
Amount of nesthetic administered to the patiet during the procedure
Time frame: baseline (immediately after the intervention)
Examination duration
Time frame: baseline (immediately after the intervention)
AE/SAE reporting
Time frame: baseline (during the intervention, immediatly after the intervetion) and at 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preparation in Self-Hypnosis by anchoring, Conversational Hypnosis and Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis in people with Breast Neoplasm Female, run by Hospital St. Joseph, Marseille, France 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 5 inclusion and 6 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 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa MILIEN (0488731070, vmilien@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in anxiety score (time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days). 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 19 Sep 2024.