Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-02

Study Completion Date

2022-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Brachytherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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experimental

patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis

Group Type EXPERIMENTAL

formal hypnosis

Intervention Type OTHER

patients will have brachytherapy detachment under Kalinox and formal hypnosis

Kalinox

Intervention Type DRUG

patients will have brachytherapy detachment under Kalinox

active comparator

patients to benefit from brachytherapy detachment under KALINOX

Group Type ACTIVE_COMPARATOR

Kalinox

Intervention Type DRUG

patients will have brachytherapy detachment under Kalinox

Interventions

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formal hypnosis

patients will have brachytherapy detachment under Kalinox and formal hypnosis

Intervention Type OTHER

Kalinox

patients will have brachytherapy detachment under Kalinox

Intervention Type DRUG

Eligibility Criteria

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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®

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No