Solid TumorPhase 2HYPNOMUSENCT04513444
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
A Phase 2 study testing Relaxation with music listening and medical hypnosis during radiotherapy treatment: and Relaxation with music listening during radiotherapy treatment: in people with Solid Tumor, run by Institut Claudius Regaud at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Relaxation with music listening and medical hypnosis during radiotherapy treatment: and Relaxation with music listening during radiotherapy treatment:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2020to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
- ECOG patient ≤ 2.
- Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- Patient doesn't understand the French language.
- Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
- Patient with hearing problems.
- Pregnant or breastfeeding women.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
Official title: Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
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
- Solid Tumor
- Being tested
- Relaxation with music listening and medical hypnosis during radiotherapy treatment:, Relaxation with music listening during radiotherapy treatment:
- Keywords
- Solid Tumor, Radiotherapy, Hypnosis, Anxiety, Music listening
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation with music listening and medical hypnosis during radiotherapy treatment:Other
- 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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard arm (A): music listening therapy | Other | Not described Receives: Other: Relaxation with music listening during radiotherapy treatment: |
| Experimental arm (B): music listening and hypnosis therapy | Experimental | Not described Receives: Other: Relaxation with music listening and medical hypnosis during radiotherapy treatment: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months for each patient
Secondary outcomes (2)
Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious")
Measured: 2 months for each patient
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).
Measured: 2 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start7 Dec 2020
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513444
- Sponsor's protocol ID
- 20 GENE 07
- Acronym
- HYPNOMUSE
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
- ClinicalTrials.gov ID
- NCT04513444
- Acronym / sponsor ID
- HYPNOMUSE / 20 GENE 07
- Conditions
- Solid Tumor
- Keywords
- Solid Tumor, Radiotherapy, Hypnosis, Anxiety, Music listening
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm (A): music listening therapy | Other | Other: Relaxation with music listening during radiotherapy treatment: |
| Experimental arm (B): music listening and hypnosis therapy | Experimental | Other: Relaxation with music listening and medical hypnosis during radiotherapy treatment: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
Key exclusion criteria (6 listed)
- Patient doesn't understand the French language.
- Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
- Patient with hearing problems.
- Pregnant or breastfeeding women.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation with music listening and medical hypnosis during radiotherapy treatment:* 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. | Other | Experimental arm (B): music listening and hypnosis therapy |
| Relaxation with music listening during radiotherapy treatment:* 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. | Other | Standard arm (A): music listening therapy |
Primary outcome
Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session)
Time frame: 2 months for each patient
Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form).
2 secondary outcomes
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 patient
Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30).
Time frame: 2 months for each patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relaxation with music listening and medical hypnosis during radiotherapy treatment: and Relaxation with music listening during radiotherapy treatment: in people with Solid Tumor, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 2 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.