Clinical trial · Interventional
Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Toolalong the Care Pathway of Patients Undergoing Breast Cancer Treatment.
Evaluation of the Impact of the Use of Hypnotherapy Performed by a Virtual Reality Tool Along the Care Pathway of Patients Undergoing Breast Cancer Treatment: Randomized Controlled Trial.
- 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)
In 2017, it is estimated that nearly 60,000 new cases of breast cancer will be diagnosed in France. Although several treatments are indicated in this context, chemotherapy remains a curability option whose place today extends to small tumors to support its increasingly approved administration contributing to a continuous increase in survival rates. However, diagnostic procedures and anti-cancer treatments are frequently responsible for toxicity that can reach high levels of severity and even generate sequelae. These physical and psychological after-effects of breast cancer treatment have a short and medium-term impact on the quality of life of the patients treated: anxiety, fear, pain, job loss, and the onset of precariousness. In addition, surgical procedures such as PAC and pic-line surgery are often associated with anxiety and pain. Chemotherapy is particularly associated with anxiety, stress, fatigue, nausea and vomiting. Some immediate, delayed or even anticipated side effects are not always effectively controlled by the medication available to us. Anti-nausea medications can lead to drug interactions and/or other adverse effects. The interest of a non-drug approach is to get rid of these adverse effects. However, it is underestimated and therefore currently not integrated into current practice. Its benefits must therefore be explored within the framework of in-depth research protocols that justify our study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncomfort® clinical virtual reality | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- no hypnotherapy
- description
- A "control" group of patients receiving the usual management for PAC and chemotherapy sessions.
- type
- EXPERIMENTAL
- label
- hypnotherapy
- description
- A "hypnotherapy" group of patients benefiting from hypnotherapy sessions prior to PAC and chemotherapy cures in addition to the usual management.
- interventionNames
- Device: Oncomfort® clinical virtual reality
Primary outcomes (1)
- measure
- Evaluate, in patients undergoing chemotherapy for the treatment of breast cancer, the impact of the use of hypnotherapy performed by a virtual reality tool on the anxiety felt just before the PAC procedure.
- timeFrame
- Day 7
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Woman whose age ≥ 18 years old * Negative pregnancy test for women of childbearing age * Francophone patient * Patient newly diagnosed with localized or metastatic breast cancer at the Paris Saint-Joseph Hospital Group (GhPSJ). * Patients in whom adjuvant or neoadjuvant chemotherapy treatment is planned * Patient affiliated to the social security system or, failing that, to another health insurance system * Patient who has given written consent. Exclusion Criteria: * Psychotic patients (paranoia, schizophrenia and manic-depressive psychosis) * Patient suffering from pathological dissociations * Deaf and hard of hearing * Blind and severely visually impaired * Patient suffering from wounds or infections in the head area * Patient suffering from respiratory disorders * Patient with a high level of claustrophobia * Patient whose investigator determines that he or she cannot wear a virtual reality helmet * Patient under guardianship or curatorship * Patient deprived of liberty. * Pregnant or breastfeeding patient.
References
Publications (0)
Data not yet available