Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies

NCT ID: NCT05027321

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasm Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Preparation in Self-Hypnosis by anchoring

1-hour consultation with a hypnopractor just before the examination

Group Type EXPERIMENTAL

Preparation in Self-Hypnosis by anchoring

Intervention Type BEHAVIORAL

Preparation in Self-Hypnosis by anchoring just before examination

Conversational Hypnosis

conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained

Group Type EXPERIMENTAL

Conversational Hypnosis

Intervention Type BEHAVIORAL

Conversational Hypnosis during examination

Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis

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

Group Type EXPERIMENTAL

Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis

Intervention Type BEHAVIORAL

Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination

Interventions

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Preparation in Self-Hypnosis by anchoring

Preparation in Self-Hypnosis by anchoring just before examination

Intervention Type BEHAVIORAL

Conversational Hypnosis

Conversational Hypnosis during examination

Intervention Type BEHAVIORAL

Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis

Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Saint Joseph

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vanessa MILIEN

Role: CONTACT

0488731070

Facility Contacts

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Vanessa MILIEN

Role: primary

Other Identifiers

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HYACOM

Identifier Type: -

Identifier Source: org_study_id

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