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NCT Number: NCT03755895

Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients

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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Key information

Conditions

Cancer Brachytherapy Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Who can participate

Healthy volunteers accepted: No

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

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®

Treatment and study plan

formal hypnosis

Other

patients will have brachytherapy detachment under Kalinox and formal hypnosis

Kalinox

Drug

patients will have brachytherapy detachment under Kalinox

Primary outcomes

  1. Anxiety evaluation

    Time frame: 1day

    The patient's anxiety will be assessed using the State-Trait Anxiety Inventory scale ("state of anxiety") before premedication (in the bedroom) and immediately after the brachytherapy detachment (in the examination room) during brachytherapy detachment using two care management: standard care versus standard care with formal hypnosis. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger et al, 1983). The scale include 20 items. Higher scores indicate greater anxiety

Secondary outcomes

  1. Pain evaluation: numeric scale

    Time frame: 1 day

    Pain will be evaluated by a numeric scale before premedication (in the room), just before and just after the brachytherapy detachment (in the examination room). Patient inform their level of pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain

  2. Anxiety evaluation

    Time frame: 1 day

    Anxiety will be evaluated by a numeric scale just before and just after the brachytherapy detachment. Patient inform their level of anxiety from 0 to 10 (11 point scale) with the understanding that 0 is equal to no anxiety and 10 is equal to worst possible anxiety

  3. Patient's perception of the care

    Time frame: 1day

    The patient's perception of the care will be evaluated by a semi-directive phone interview conducted by the medical staff between day 3 and day 5 after the brachytherapy detachment

  4. Time of brachytherapy detachment

    Time frame: 1day

    The time of brachytherapy detachment will be noted from the entrance to the patient's examination room until the end of the brachytherapy detachment

  5. Realization of the brachytherapy detachment

    Time frame: 1day

    The ease of realization of the brachytherapy detachment and the comfort of the medical staff will be evaluated by an numeric scale at the end of the care and by a self-survey

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy

Acronym: HYCUDES

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 28, 2018
Registry last updated
Oct 3, 2025

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.

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