Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies
Primary Purpose
Breast Neoplasm Female
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Preparation in Self-Hypnosis by anchoring
Conversational Hypnosis
Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Sponsored by
About this trial
This is an interventional other trial for Breast Neoplasm Female
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
Sites / Locations
- Hôpital Saint JosephRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Control
Preparation in Self-Hypnosis by anchoring
Conversational Hypnosis
Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Arm Description
control
1-hour consultation with a hypnopractor just before the examination
conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change in anxiety score
measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)
change in pain score
measured on pain visual analog scale from 0 (no pain) to 10 (worst pain)
patient examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
staff examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
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.
Amount of nesthetic administered to the patiet during the procedure
mL
Examination duration
minutes
AE/SAE reporting
Full Information
NCT ID
NCT05027321
First Posted
August 16, 2021
Last Updated
October 19, 2022
Sponsor
Hospital St. Joseph, Marseille, France
1. Study Identification
Unique Protocol Identification Number
NCT05027321
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital St. Joseph, Marseille, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
control
Arm Title
Preparation in Self-Hypnosis by anchoring
Arm Type
Experimental
Arm Description
1-hour consultation with a hypnopractor just before the examination
Arm Title
Conversational Hypnosis
Arm Type
Experimental
Arm Description
conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained
Arm Title
Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Preparation in Self-Hypnosis by anchoring
Intervention Description
Preparation in Self-Hypnosis by anchoring just before examination
Intervention Type
Behavioral
Intervention Name(s)
Conversational Hypnosis
Intervention Description
Conversational Hypnosis during examination
Intervention Type
Behavioral
Intervention Name(s)
Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Intervention Description
Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination
Primary Outcome Measure Information:
Title
change in anxiety score
Description
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.
Time Frame
baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
Secondary Outcome Measure Information:
Title
change in anxiety score
Description
measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)
Time Frame
baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
Title
change in pain score
Description
measured on pain visual analog scale from 0 (no pain) to 10 (worst pain)
Time Frame
baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
Title
patient examination experience
Description
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
Time Frame
baseline (immediately after the intervention)
Title
staff examination experience
Description
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
Time Frame
baseline (immediately after the intervention)
Title
anxiety score
Description
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.
Time Frame
baseline (pre-intervention)
Title
Amount of nesthetic administered to the patiet during the procedure
Description
mL
Time Frame
baseline (immediately after the intervention)
Title
Examination duration
Description
minutes
Time Frame
baseline (immediately after the intervention)
Title
AE/SAE reporting
Time Frame
baseline (during the intervention, immediatly after the intervetion) and at 8 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecile BIELMANN
Phone
0488731070
Email
cbielmann@hopital-saint-joseph.fr
Facility Information:
Facility Name
Hôpital Saint Joseph
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Bielmann
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies
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