Actively Recruiting
Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies: a Randomized Study
Led by Hospital St. Joseph, Marseille, France · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women undergoing breast macrobiopsies to evaluate different hypnosis methods aimed at reducing anxiety and pain during this stressful and often painful procedure. The study focuses on comparing preparation in self-hypnosis by anchoring, conversational hypnosis during the examination, and their combination. The goal is to find which hypnosis method best helps manage patients' anxiety and pain, as no clear evidence currently supports one approach over another. Participants are randomly assigned to one of four groups: a control group with no hypnosis intervention; a group receiving a one-hour self-hypnosis preparation session before the biopsy; a group receiving conversational hypnosis support during the procedure by trained staff; and a group receiving both the self-hypnosis preparation and conversational hypnosis during the examination. These behavioral interventions are designed to be applied immediately before or during the biopsy. During the study, anxiety and pain levels are measured before, during, immediately after the intervention, and again eight days later. Patient and staff experiences during the biopsy are recorded, along with the amount of anesthetic used and the duration of the procedure. Safety is monitored through adverse event reporting during and after the intervention. Participation includes one consultation for hypnosis preparation when applicable and the biopsy procedure, with follow-up assessments extending up to eight days post-examination.
CONDITIONS
Brief Title
Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or older
- Referred to the medical imaging department for breast macrobiopsy
- No prior experience with hypnosis
- Given free, informed, and written consent
- Affiliated with or beneficiary of a social security scheme
You will not qualify if you...
- Major hearing loss
- Diagnosed mental or psychotic disorders
- Unable to understand French
- Previous experience with hypnosis
- Current pregnancy
- Subject to a legal safeguard measure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 hour just before examination
Participants receive a 1-hour consultation with a hypnopractor just before the breast macrobiopsy examination.
1 visit (in-person)
Duration - Duration of the breast macrobiopsy examination
Participants receive conversational hypnosis support during the breast macrobiopsy examination by trained radiology staff.
1 visit (in-person)
Duration - 1 hour consultation plus duration of examination
Participants receive both a 1-hour consultation with a hypnopractor just before and conversational hypnosis support during the breast macrobiopsy examination.
1 visit (in-person)
Duration - 8 days after examination
Participants are followed up to assess anxiety and pain scores and report any adverse events after the intervention.
1 follow-up visit or contact
Trial Site Locations
Total: 1 location
1
Hôpital Saint Joseph
Marseille, France
Actively Recruiting
Research Team
V
Vanessa MILIEN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here