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Conversational Hypnosis in Women Undergoing Imaging for Breast Cancer

Randomized Trial Comparing the Contribution of Conversational Hypnosis Versus Standard Care on Patient Anxiety During a Preoperative Breast Tracking

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02867644
Acronym
HYCOREMA
Enrollment
171
Registered
2016-08-16
Start date
2016-11-17
Completion date
2020-10-16
Last updated
2022-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

conversational hypnosis, imaging, care, breast neoplasia, anxiety, pain

Brief summary

The hypothesis is to assess the contribution of conversational hypnosis on anxiety of patients who undergoing for a preoperative breast tracking and improve their care

Interventions

OTHERstandard care

Patients coming for preoperative breast assessment will have standard care.

OTHERstandard care + conversational hypnosis

Patients coming for preoperative breast assessment will have standard care with conversational hypnosis

Sponsors

Institut de Cancérologie de Lorraine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients ≥ 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Patient undergoing for a preoperative breast assessment * Patient must be affiliated to a social security system * Ability to provide an informed written consent form

Exclusion criteria

* Patients diagnosed with major hearing loss * Patients with schizophrenia * Patients do not understand the French language * Pregnant or breast feeding females * Refusal of the patient to participate in the study * Persons deprived of liberty or under supervision

Design outcomes

Primary

MeasureTime frameDescription
Compare anxiety of patients undergoing for a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)Day 1The anxiety level will be assessed in each group by a visual analog scale from 0 to 10.

Secondary

MeasureTime frameDescription
Compare the pain felt by patients during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)Day 1The pain level will be assessed in each group by a visual analog scale from 0 to 10.
Compare the manipulator's satisfaction during a preoperative breast marking under ultrasound according two different procedures (standard care versus standard care with conversational hypnosis)Day 1The manipulator's satisfaction will be assessed in each group by a numeric scale from 0 to 10.
Evaluate the receptivity of women to conversational hypnosisDay 1assessment realisation time flet by patient
Assess the impact of conversational hypnosis on completion of the examinationDay 1The assessment will be evaluated in each group by the radiologist according to a visual analog scale from 0 to 10.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026