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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Brachytherapy
• Intervention / Treatment: Other: formal hypnosis; Drug: Kalinox

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54519
    • Institut de Cancérologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis	Other: formal hypnosis; patients will have brachytherapy detachment under Kalinox and formal hypnosis; Drug: Kalinox; patients will have brachytherapy detachment under Kalinox
Active Comparator: active comparator; patients to benefit from brachytherapy detachment under KALINOX	Drug: Kalinox; patients will have brachytherapy detachment under Kalinox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Principal Investigator: Sophie RENARD, Md, Institut de Cancérologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2019
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; hypnosis; care management
• Other Study ID Numbers: 2018-004527-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No