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

NCT05027321 | Recruiting

• 1 other identifier: HYACOM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days

Secondary Outcomes (8)

• change in anxiety score

  baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days

• change in pain score

  baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days

• patient examination experience

  baseline (immediately after the intervention)

• staff examination experience

  baseline (immediately after the intervention)

• anxiety score

  baseline (pre-intervention)

Study Arms (4)

Control

NO INTERVENTION

control

Preparation in Self-Hypnosis by anchoring

EXPERIMENTAL

1-hour consultation with a hypnopractor just before the examination

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

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

Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis

Interventions

Preparation in Self-Hypnosis by anchoring BEHAVIORAL

Preparation in Self-Hypnosis by anchoring just before examination

Preparation in Self-Hypnosis by anchoring

Conversational Hypnosis BEHAVIORAL

Conversational Hypnosis during examination

Conversational Hypnosis

Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis BEHAVIORAL

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

Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hôpital Saint Joseph

Marseille, France

RECRUITING

Central Study Contacts

Vanessa MILIEN

CONTACT

0488731070; vmilien@hopital-saint-joseph.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 30, 2021
• Study Start: October 11, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)