Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients

Phase 2

Completed

• Conditions: Cancer; Brachytherapy
• Interventions: Other: formal hypnosis; Drug: Kalinox

• Registration Number: NCT03755895
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2019-11-02
• Primary Completion: 2022-05-17
• Study Completion: 2022-05-25
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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®

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	formal hypnosis	patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis
active comparator	Kalinox	patients to benefit from brachytherapy detachment under KALINOX
experimental	Kalinox	patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis

Primary Outcome Measures

Name	Time	Method
Anxiety evaluation	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 Outcome Measures

Name	Time	Method
Realization of the brachytherapy detachment	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
Time of brachytherapy detachment	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
Anxiety evaluation	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
Pain evaluation: numeric scale	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
Patient's perception of the care	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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France