Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients (HYCUDES)

Institut de Cancérologie de Lorraine

Status and phase: Completed; Phase 2

Conditions: Cancer; Brachytherapy

Treatments: Drug: Kalinox; Other: formal hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03755895

2018-004527-37

Details and patient eligibility

About

Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the preoperative procedure.

In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for patients treated for prostate cancer The goal of the study is to demonstrate the added value of hypnosis during a brachytherapy detachment by improving the comfort of the patient.

The investigators want to evaluate the contribution of hypnosis during brachytherapy detachment by quantifying the anxiety and pain felt by the patient during the procedure.

Enrollment: 68 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥ 18 and ≤ 80 years

• Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the types of applications described below:

  • Deep interstitial application: anal canal, vagina, vulva
  • Gynecological application: mold, Utrecht® system or Venezia® system

• Ability to provide written informed consent

• Patients affiliated to the social security system

Exclusion criteria

• Minor and patients over 80 years old
• Patients with major hearing loss
• Patients who had recent ocular surgery with oculiare gas injection.
• Patients suffering from psychotic disorders, and dementias.
• Patients who do not understand the French language
• Patients under guardianship or deprived of liberty
• Patients with a contraindication to the administration of KALINOX®

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

experimental

Experimental group

Description:

patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis

Treatment:

Other: formal hypnosis

Drug: Kalinox

active comparator

Active Comparator group

Description:

patients to benefit from brachytherapy detachment under KALINOX

Treatment:

Drug: Kalinox