Clinical trial · Interventional
Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients
Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brachytherapy | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| formal hypnosis | Other | — | UNRESOLVED |
| Kalinox | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental
- description
- patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis
- interventionNames
- Other: formal hypnosis
- Drug: Kalinox
- type
- ACTIVE_COMPARATOR
- label
- active comparator
- description
- patients to benefit from brachytherapy detachment under KALINOX
- interventionNames
- Drug: Kalinox
Primary outcomes (1)
- measure
- Anxiety evaluation
- timeFrame
- 1day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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®
References
Publications (1)
- RESULTLemoine 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 40883194