Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05027321

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Neoplasm Female

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint Joseph

Marseille, France

Location status: Recruiting

Location contact

Vanessa MILIEN

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preparation in Self-Hypnosis by anchoring

Behavioral

Preparation in Self-Hypnosis by anchoring just before examination

Conversational Hypnosis

Behavioral

Conversational Hypnosis during examination

Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis

Behavioral

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

Primary outcomes

  1. change in anxiety score

    Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days

    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 outcomes

  1. change in anxiety score

    Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days

    measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)

  2. change in pain score

    Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days

    measured on pain visual analog scale from 0 (no pain) to 10 (worst pain)

  3. patient examination experience

    Time frame: baseline (immediately after the intervention)

    measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)

  4. staff examination experience

    Time frame: baseline (immediately after the intervention)

    measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)

  5. anxiety score

    Time frame: baseline (pre-intervention)

    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.

  6. Amount of nesthetic administered to the patiet during the procedure

    Time frame: baseline (immediately after the intervention)

    mL

  7. Examination duration

    Time frame: baseline (immediately after the intervention)

    minutes

  8. AE/SAE reporting

    Time frame: baseline (during the intervention, immediatly after the intervetion) and at 8 days

Study contacts

Contact information is provided by the study sponsor or research team.

Vanessa MILIEN

CONTACT

[email protected]

0488731070

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 30, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.