NCT03755895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

November 2, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

November 26, 2018

Last Update Submit

September 30, 2025

Conditions

CancerBrachytherapy

Keywords

Cancerhypnosiscare management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pain evaluation: numeric scale

    1 day

  • Anxiety evaluation

    1 day

  • Patient's perception of the care

    1day

  • Time of brachytherapy detachment

    1day

  • Realization of the brachytherapy detachment

    1day

Study Arms (2)

experimental

EXPERIMENTAL

patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis

Other: formal hypnosisDrug: Kalinox

active comparator

ACTIVE COMPARATOR

patients to benefit from brachytherapy detachment under KALINOX

Drug: Kalinox

Interventions

formal hypnosisOTHER

patients will have brachytherapy detachment under Kalinox and formal hypnosis

experimental
KalinoxDRUG

patients will have brachytherapy detachment under Kalinox

active comparatorexperimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

  • Lemoine L, Adam V, Salleron J, Cuisinier C, Perrin J, Brunaud CC, Jean-Francois P, Bruand M, Peiffert D, Etienne R, Schohn CH, Renard S. Randomized trial comparing hypnosis versus standard management on patient anxiety and pain during pelvic brachytherapy applicator removal. Brachytherapy. 2025 Nov-Dec;24(6):854-862. doi: 10.1016/j.brachy.2025.07.010. Epub 2025 Aug 28.

    PMID: 40883194BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

kalinox

Study Officials

  • Sophie RENARD, Md

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 28, 2018

Study Start

November 2, 2019

Primary Completion

May 17, 2022

Study Completion

May 25, 2022

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)