Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Claudius Regaud
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at the time of enrollment into the study.
Patient with localized or metastatic solid malignant tumor.
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).
Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
Disqualifiers
Patient doesn't understand the French language.
Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
Patient with hearing problems.
Pregnant or breastfeeding women.
Trial design
Design model
Parallel
Treatments tested in this trial
Relaxation with music listening and medical hypnosis during radiotherapy treatment:
Other intervention* Music listening (According to the patient's wishes), * Hypnosis sessions with the hypnotherapist during the 1st, 2nd and 3rd radiotherapy session, * Self-hypnosis during the 4th and 5th radiotherapy session, * Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.
Relaxation with music listening during radiotherapy treatment:
Other intervention* Music listening (According to the patient's wishes), * Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Standard arm (A): music listening therapyOther 1 intervention
Group B: Experimental arm (B): music listening and hypnosis therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)
Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).
Time frame
2 months for each patientSecondary outcomes
1
Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious")
Time frame
2 months for each patient2
Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30).
Changes in quality of life from baseline will be assessed in the classroom according to the recommendations of the literature (Osoba, JCO).
Time frame
2 months for each patientSponsors and contacts
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Source ClinicalTrials.gov