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

Breast Neoplasm Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05027321
• Other study ID #: HYACOM
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: July 2024

Study information

• Verified date: October 2022
• Source: Hospital St. Joseph, Marseille, France
• Contact: Cecile BIELMANN
• Phone: 0488731070
• Email: cbielmann[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Behavioral:
• Preparation in Self-Hypnosis by anchoring
Preparation in Self-Hypnosis by anchoring just before examination
• Conversational Hypnosis
Conversational Hypnosis during examination
• Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination

Locations

Country	Name	City	State
France	Hôpital Saint Joseph	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Amount of nesthetic administered to the patiet during the procedure	mL	baseline (immediately after the intervention)
Secondary	Examination duration	minutes	baseline (immediately after the intervention)
Secondary	AE/SAE reporting		baseline (during the intervention, immediatly after the intervetion) and at 8 days