Clinical trial · Interventional
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment. 45 patients will be randomized into the following arms: * Arm A (standard): relaxation with music listening during radiotherapy treatment * Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment For the study each patient will be followed during 2 months.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Relaxation with music listening and medical hypnosis during radiotherapy treatment: | Other | — | UNRESOLVED |
| Relaxation with music listening during radiotherapy treatment: | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard arm (A): music listening therapy
- interventionNames
- Other: Relaxation with music listening during radiotherapy treatment:
- type
- EXPERIMENTAL
- label
- Experimental arm (B): music listening and hypnosis therapy
- interventionNames
- Other: Relaxation with music listening and medical hypnosis during radiotherapy treatment:
Primary outcomes (1)
- measure
- Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)
- timeFrame
- 2 months for each patient
- description
- Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years at the time of enrollment into the study. 2. Patient with localized or metastatic solid malignant tumor. 3. Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study). 4. Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy. 5. Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion). 6. ECOG patient ≤ 2. 7. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures. 8. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Patient doesn't understand the French language. 2. Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment. 3. Patient with hearing problems. 4. Pregnant or breastfeeding women. 5. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol. 6. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
References
Publications (0)
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