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

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.

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 Overview

• Status: Recruiting
• Conditions: Breast Neoplasm Female
• Intervention / Treatment: Behavioral: Preparation in Self-Hypnosis by anchoring; Behavioral: Conversational Hypnosis; Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecile BIELMANN; Phone Number: 0488731070; Email: cbielmann@hopital-saint-joseph.fr

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Hopital Saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; control
EXPERIMENTAL: Preparation in Self-Hypnosis by anchoring; 1-hour consultation with a hypnopractor just before the examination	Behavioral: Preparation in Self-Hypnosis by anchoring; Preparation in Self-Hypnosis by anchoring just before examination
EXPERIMENTAL: Conversational Hypnosis; conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained	Behavioral: Conversational Hypnosis; Conversational Hypnosis during examination
EXPERIMENTAL: 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	Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis; Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in anxiety score	measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)	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)	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)	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)	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.	baseline (pre-intervention)
Amount of nesthetic administered to the patiet during the procedure	mL	baseline (immediately after the intervention)
Examination duration	minutes	baseline (immediately after the intervention)
AE/SAE reporting		baseline (during the intervention, immediatly after the intervetion) and at 8 days

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2022
• Primary Completion (ANTICIPATED): July 1, 2024
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (ACTUAL): August 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HYACOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No