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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital St. Joseph, Marseille, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

having a major hearing loss,

suffering from identified mental or psychotic disorders,

not understanding the French language,

having already had hypnosis practices,

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Preparation in Self-Hypnosis by anchoringExperimental treatment 1 intervention
Group C: Conversational HypnosisExperimental treatment 1 intervention
Group D: Preparation in Self-Hypnosis by anchoring + Conversational HypnosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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: 1. \> 65 (very high), 2. from 56 to 65 (high), 3. from 46 to 55 (medium), 4. from 36 to 45 (low), 5. \< 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 outcomes

1

change in anxiety score

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
2

change in pain score

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
3

patient examination experience

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

Time frame
baseline (immediately after the intervention)
4

staff examination experience

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

Time frame
baseline (immediately after the intervention)

Other outcomes

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