Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients

Cancer Clinical Trial

— HYCUDES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755895
• Other study ID #: 2018-004527-37
• Status: Completed
• Phase: Phase 2
• Start date: November 2, 2019
• Est. completion date: May 25, 2022

Study information

• Verified date: December 2022
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 25, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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®

Related Conditions & MeSH terms

• Brachytherapy
• Cancer

Intervention

Other:
• formal hypnosis
patients will have brachytherapy detachment under Kalinox and formal hypnosis

Drug:
• Kalinox
patients will have brachytherapy detachment under Kalinox

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety evaluation	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	1day
Secondary	Pain evaluation: numeric scale	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	1 day
Secondary	Anxiety evaluation	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	1 day
Secondary	Patient's perception of the care	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	1day
Secondary	Time of brachytherapy detachment	The time of brachytherapy detachment will be noted from the entrance to the patient's examination room until the end of the brachytherapy detachment	1day
Secondary	Realization of the brachytherapy detachment	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	1day