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Recruiting NCT05027321

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

No phase Interventional Breast Neoplasm Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preparation in Self-Hypnosis by anchoring, Conversational Hypnosis, Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis.
Who it may be relevant to
Registry conditions: Breast Neoplasm Female. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • change in anxiety score [Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days]
Secondary outcome measures (8)
  • change in anxiety score [Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days]
  • change in pain score [Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days]
  • patient examination experience [Time frame: baseline (immediately after the intervention)]
  • staff examination experience [Time frame: baseline (immediately after the intervention)]
  • anxiety score [Time frame: baseline (pre-intervention)]
  • Amount of nesthetic administered to the patiet during the procedure [Time frame: baseline (immediately after the intervention)]
  • Examination duration [Time frame: baseline (immediately after the intervention)]
  • AE/SAE reporting [Time frame: baseline (during the intervention, immediatly after the intervetion) and at 8 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Hôpital Saint Joseph — Marseille

Identifiers

NCT: NCT05027321 · HYACOM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗