Cancer (With or Without Metastasis)HYPNEANCT07173348
Hypnosis on Breathlessness Mastery in Patients With Persistent Dyspnea
A study testing Hypnosis in people with Cancer (With or Without Metastasis) and Interstitial Lung Disease (ILD), run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Persistent dyspnea is a debilitating symptom, that is common and difficult to treat. This symptom is found in many different diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), chronic heart failure (CHF), and metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer (With or Without Metastasis), Interstitial Lung Disease (ILD), Chronic Heart Failure (CHF)
- What is being tested?
- Hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- 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
- Patients aged ≥ 18 years and
- Primary diagnosis of metastatic cancer, COPD stage at least B or E, ILD, or CHF and
- Dyspnea stage NYHA ≥ II or mMRC ≥ 2
Who cannot join
- Have had hypnosis treatment in the last 12 months
- Have an estimated life expectancy of less than 6 months
- Have participated in pulmonary rehabilitation in the last 6 months
- Have been hospitalised in the last month (30 days)
- Are unable to come to the hospital for 3 outpatient consultations (1 every two weeks)
- Have a condition that would interfere with their ability to respond to the questionnaires (i.e. cognitive impairment, hearing impairment, etc.)
- Are not eligible for a hypnosis session due to a psychiatric disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Federica Bianchi, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1211
Lisa Hentsch, Dr, +41 22 305 66 12, lisa.hentsch@hug.ch
Federica Bianchi, PhD, federica.bianchi@hug.ch
About this study
Official title: Effectiveness of Hypnosis on Breathlessness Mastery in Patients With Persistent Dyspnea: a Randomised Controlled Trial
Persistent dyspnea is a debilitating symptom, that is common and difficult to treat. This symptom is found in many different diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), chronic heart failure (CHF), and metastatic cancer. Dyspnea is associated with many other symptoms, including anxiety, depression, and fatigue and is responsible for a significant reduction in quality of life. To date, only opiates are recommended for the pharmacological treatment of persistent dyspnea.
The effectiveness of hypnosis is well known in the treatment of anxiety and delivered to patients suffering from chronic dyspnea for this reason. One randomised controlled study has shown that a single 20-minute mindfulness sessions could significantly reduce general symptom burden and have a significant impact on anxiety and depression in palliative care patients. Furthermore, the intervention had no negative side effects.
Our aim is to evaluate the effectiveness of three hypnosis sessions on breathlessness mastery in patients with persistent dyspnea, using as a primary outcome the mastery domain of a validated tool, the Chronic Respiratory Questionnaire (CRQ).
Read the detailed description
Hypnosis is currently used to reduce anxiety in patients with breathlessness. Although a reduction in anxiety has been correlated with a reduction in dyspnea, the effectiveness of hypnosis on breathlessness self-management has not yet been evaluated. As medical options for the treatment of chronic persistent breathlessness are limited, finding new, innovative ways, to help patients feel more confident in the management of their dyspnea should be a priority. Some interventions such as pulmonary rehabilitation, the hand-held fan and walking aids have been proven to be effective. However, patients with advance disease may not be well enough to endure physical interventions such as pulmonary rehabilitation.
Hypnosis has been shown to be safe and to diminish anxiety in patients suffering from Chronic Obstructive pulmonary disease (COPD). The risk linked to hypnosis is considered minimal as participants may interrupt the hypnosis session at any time and there are no known side effects to hypnosis. Additionally, patients could benefit from the proven reduction of anxiety. The benefits for patients clearly outweigh the risks.
The objective of this prospective parallel randomised controlled trial is to determine the effectiveness of hypnosis on breathlessness mastery in patients with persistant dyspnea and advanced disease. The primary endpoint is the patient-reported breathlessness mastery as measured with the mastery subscale of the Chronic Respiratory Questionnaire (CRQ) after three hypnosis sessions.
Participants will undergo three 15-minute individual hypnosis intervention, conducted by a trained hypnotherapist, with a two-week interval between each session. A guide has been developed by two experimented hypnotherapists specifically for this intervention and will be used for all sessions. The control group will undergo usual care (no hypnosis).
Participants will be recruited at the outpatient consultations of cardiology, pneumology, oncology, primary care and palliative care of the Geneva University Hospital (single centre) by their treating physician. All eligible participants will be presented with the objectives of the study, the procedures involved, the timing of the intervention and will receive an information sheet about the study. Eligible participants will be contacted by a research associate in the following days. If they consent to participate, participants will be randomised to receive either the intervention (3 hypnosis sessions) or usual care.
At inclusion time (T0), all participants will be asked to complete a set of questionnaires: the Chronic Respiratory Questionnaire (CRQ), the Hospital Anxiety and Depression Scale (HADS), the Dyspnea-12 questionnaire (D-12) and the European Quality of Life 5 DImensions 5 Level Version (EQ5D5L), as well as score their worst breathlessness on a numerical scale from 0 to 10, 0 being no breathlessness and 10 worst imaginable breathlessness. These questionnaires will be repeated at the end of the third session. Following the final (third) hypnosis session, participants will be asked about the acceptability of the intervention on a 5-point Likert scale ranging from 0 (not acceptable) to 5 (totally acceptable).
A follow up with the CRQ will be conducted 1 month after the end of the last session.
- Conditions
- Cancer (With or Without Metastasis), Interstitial Lung Disease (ILD), Chronic Heart Failure (CHF), COPD, Dyspnea
- Being tested
- Hypnosis
- Keywords
- Hypnosis, Persistant dyspnea, Cancer with metastasis, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Chronic Heart Failure, Palliative Care
- Medical subject headings
- Neoplasms, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisOther
Participants will undergo three 15-minute individual hypnosis intervention, conducted by a trained hypnotherapist, with a two-week interval between each session. A guide for the session has been developed by two experimented hypnotherapists specifically for this intervention and will be used for all sessions. A total of 3 hypnosis session will be realized.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | 3 hypnosis sessions separated by 15 days Receives: Other: Hypnosis |
| Usual Care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Respiratory Questionnaire (CRQ): sub scale mastery
The CRQ is a validated 20-item health-related quality of life questionnaire in which experiences are rated on seven-point scales ranging from 1 (maximum impairment) to 7 (no impairment). The CRQ mastery is a domain of the CRQ which comprises four questions with a range of scores also ranging from 1 to 7
Measured: From enrollment to the end of the intervention at 6 weeks.
Secondary outcomes (6)
Worst breathlessness on the numerical rating scale (NRS)
The numerical rating scale (NRS) ranges from 0 (no breathlessness) to 10 (worst breathlessness).
Measured: From enrollment (T0) to the end of the intervention at 6 weeks.
Physical and affective component of dyspnea with the Dyspnea-12 scale
The Dyspnea-12 (D-12) scale is a tool to help to assess the dyspnea. Dyspnea is a multidimensional symptom, comprising physical (intensity, location, temporality and sensory quality) and affective (unpleasant) sensations.
This D-12 questionnaire is a dyspnea assessment tool. It contains 12 items. The first 7 items correspond to the evaluation of the sensory aspect and the next 5 to the evaluation of the affective aspect. The higher is the score the higher is the burden of dyspnea.
Measured: From enrollment (T0) to the end of the intervention at 6 weeks
Quality of Life with EQ5D5L
The EQ-5D-5L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient own judgement.
Measured: From enrollment (T0) to the end of the intervention at 6 weeks
Acceptability
Acceptability will be evaluate at the end of the 3 hypnosis session. with the help of a Lickert scale: completely agree, agree, neutral, don't agree, completely disagree.
Measured: at the end of the intervention at 6 weeks
Anxiety an Depression (HADS)
Anxiety an Depression wil be evaluated with HADS questionnaire which comprises two sub-cathegories, HADS-D for dépression (0-21) and HADS-A for anxiety (0-21)
Measured: From enrollment (T0) to the end of the intervention at 6 weeks
Duration of hypnosis sessions
duration in minutes for each hypnosis sessions
Measured: After each hypnosis sessions (at 2, 4 and 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Apr 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer (With or Without Metastasis)Studies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, mono-centric, randomised-controlled trial with a two-arm parallel design
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Lancardis Foundation
- Responsible party
- Principal investigator, Lisa Hentsch, University Hospital, Geneva
- Investigators
- Lisa Hentsch, Dr med, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173348
- Sponsor's protocol ID
- HYPNEA
- Acronym
- HYPNEA
- Status last verified
- May 2026
- First submitted
- 26 Aug 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to automatically share IPD, but available upon reasonable request once the publication of the study has been made.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hypnosis on Breathlessness Mastery in Patients With Persistent Dyspnea: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07173348
- Acronym / sponsor ID
- HYPNEA / HYPNEA
- Conditions
- Cancer (With or Without Metastasis), Interstitial Lung Disease (ILD), Chronic Heart Failure (CHF), COPD, Dyspnea
- Keywords
- Hypnosis, Persistant dyspnea, Cancer with metastasis, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Chronic Heart Failure, Palliative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Lancardis Foundation
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 15 Sep 2025 (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.
Persistent dyspnea is a debilitating symptom, that is common and difficult to treat. This symptom is found in many different diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), chronic heart failure (CHF), and metastatic cancer. Dyspnea is associated with many other symptoms, including anxiety, depression, and fatigue and is responsible for a significant reduction in quality of life. To date, only opiates are recommended for the pharmacological treatment of persistent dyspnea.
The effectiveness of hypnosis is well known in the treatment of anxiety and delivered to patients suffering from chronic dyspnea for this reason. One randomised controlled study has shown that a single 20-minute mindfulness sessions could significantly reduce general symptom burden and have a significant impact on anxiety and depression in palliative care patients. Furthermore, the intervention had no negative side effects.
Our aim is to evaluate the effectiveness of three hypnosis sessions on breathlessness mastery in patients with persistent dyspnea, using as a primary outcome the mastery domain of a validated tool, the Chronic Respiratory Questionnaire (CRQ).
Detailed description
Hypnosis is currently used to reduce anxiety in patients with breathlessness. Although a reduction in anxiety has been correlated with a reduction in dyspnea, the effectiveness of hypnosis on breathlessness self-management has not yet been evaluated. As medical options for the treatment of chronic persistent breathlessness are limited, finding new, innovative ways, to help patients feel more confident in the management of their dyspnea should be a priority. Some interventions such as pulmonary rehabilitation, the hand-held fan and walking aids have been proven to be effective. However, patients with advance disease may not be well enough to endure physical interventions such as pulmonary rehabilitation.
Hypnosis has been shown to be safe and to diminish anxiety in patients suffering from Chronic Obstructive pulmonary disease (COPD). The risk linked to hypnosis is considered minimal as participants may interrupt the hypnosis session at any time and there are no known side effects to hypnosis. Additionally, patients could benefit from the proven reduction of anxiety. The benefits for patients clearly outweigh the risks.
The objective of this prospective parallel randomised controlled trial is to determine the effectiveness of hypnosis on breathlessness mastery in patients with persistant dyspnea and advanced disease. The primary endpoint is the patient-reported breathlessness mastery as measured with the mastery subscale of the Chronic Respiratory Questionnaire (CRQ) after three hypnosis sessions.
Participants will undergo three 15-minute individual hypnosis intervention, conducted by a trained hypnotherapist, with a two-week interval between each session. A guide has been developed by two experimented hypnotherapists specifically for this intervention and will be used for all sessions. The control group will undergo usual care (no hypnosis).
Participants will be recruited at the outpatient consultations of cardiology, pneumology, oncology, primary care and palliative care of the Geneva University Hospital (single centre) by their treating physician. All eligible participants will be presented with the objectives of the study, the procedures involved, the timing of the intervention and will receive an information sheet about the study. Eligible participants will be contacted by a research associate in the following days. If they consent to participate, participants will be randomised to receive either the intervention (3 hypnosis sessions) or usual care.
At inclusion time (T0), all participants will be asked to complete a set of questionnaires: the Chronic Respiratory Questionnaire (CRQ), the Hospital Anxiety and Depression Scale (HADS), the Dyspnea-12 questionnaire (D-12) and the European Quality of Life 5 DImensions 5 Level Version (EQ5D5L), as well as score their worst breathlessness on a numerical scale from 0 to 10, 0 being no breathlessness and 10 worst imaginable breathlessness. These questionnaires will be repeated at the end of the third session. Following the final (third) hypnosis session, participants will be asked about the acceptability of the intervention on a 5-point Likert scale ranging from 0 (not acceptable) to 5 (totally acceptable).
A follow up with the CRQ will be conducted 1 month after the end of the last session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, mono-centric, randomised-controlled trial with a two-arm parallel design
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Other: Hypnosis3 hypnosis sessions separated by 15 days |
| Usual Care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥ 18 years and
- Primary diagnosis of metastatic cancer, COPD stage at least B or E, ILD, or CHF and
- Dyspnea stage NYHA ≥ II or mMRC ≥ 2
Key exclusion criteria (7 listed)
- Have had hypnosis treatment in the last 12 months
- Have an estimated life expectancy of less than 6 months
- Have participated in pulmonary rehabilitation in the last 6 months
- Have been hospitalised in the last month (30 days)
- Are unable to come to the hospital for 3 outpatient consultations (1 every two weeks)
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 |
|---|---|---|
| HypnosisParticipants will undergo three 15-minute individual hypnosis intervention, conducted by a trained hypnotherapist, with a two-week interval between each session. A guide for the session has been developed by two experimented hypnotherapists specifically for this intervention and will be used for all sessions. A total of 3 hypnosis session will be realized. | Other | Hypnosis |
Primary outcome
Chronic Respiratory Questionnaire (CRQ): sub scale mastery
Time frame: From enrollment to the end of the intervention at 6 weeks.
The CRQ is a validated 20-item health-related quality of life questionnaire in which experiences are rated on seven-point scales ranging from 1 (maximum impairment) to 7 (no impairment). The CRQ mastery is a domain of the CRQ which comprises four questions with a range of scores also ranging from 1 to 7
6 secondary outcomes
Worst breathlessness on the numerical rating scale (NRS)
Time frame: From enrollment (T0) to the end of the intervention at 6 weeks.
Physical and affective component of dyspnea with the Dyspnea-12 scale
Time frame: From enrollment (T0) to the end of the intervention at 6 weeks
Quality of Life with EQ5D5L
Time frame: From enrollment (T0) to the end of the intervention at 6 weeks
Acceptability
Time frame: at the end of the intervention at 6 weeks
Anxiety an Depression (HADS)
Time frame: From enrollment (T0) to the end of the intervention at 6 weeks
Duration of hypnosis sessions
Time frame: After each hypnosis sessions (at 2, 4 and 6 weeks)
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 8 Jun 2026.
- Individual participant dataSharing planned: No. No plan to automatically share IPD, but available upon reasonable request once the publication of the study has been made.
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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.
Federica Bianchi, PhD contact
Lisa Hentsch, Dr med principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Cancer (With or Without Metastasis) and Interstitial Lung Disease (ILD), run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Jun 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 Switzerland. 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.
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?
Contact Lisa Hentsch, Dr med (+41 22 305 66 12, lisa.hentsch@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Respiratory Questionnaire (CRQ): sub scale mastery (time frame: From enrollment to the end of the intervention at 6 weeks.). 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 8 Jun 2026.