Clinical trial NCT05027321: Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm Female
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: change in anxiety score
timeFrame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
Secondary outcomes:
measure: change in anxiety score
timeFrame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
measure: change in pain score
timeFrame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
measure: patient examination experience
timeFrame: baseline (immediately after the intervention)
measure: staff examination experience
timeFrame: baseline (immediately after the intervention)
measure: anxiety score
timeFrame: baseline (pre-intervention)
measure: Amount of nesthetic administered to the patiet during the procedure
timeFrame: baseline (immediately after the intervention)
measure: Examination duration
timeFrame: baseline (immediately after the intervention)
measure: AE/SAE reporting
timeFrame: baseline (during the intervention, immediatly after the intervetion) and at 8 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Saint Joseph
Study officials:
References: