An interventional study of Hypnosis in Cancer (With or Without Metastasis), Interstitial Lung Disease (ILD) and Chronic Heart Failure (CHF), sponsored by University Hospital, Geneva. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Supportive care
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).
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.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 hypnosis sessions separated by 15 days
Other: Hypnosis
Usual care
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.
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
Time frame: From enrollment to the end of the intervention at 6 weeks.
Worst breathlessness on the numerical rating scale (NRS)
The numerical rating scale (NRS) ranges from 0 (no breathlessness) to 10 (worst breathlessness).
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: From enrollment (T0) to the end of the intervention at 6 weeks
Duration of hypnosis sessions
duration in minutes for each hypnosis sessions
Time frame: After each hypnosis sessions (at 2, 4 and 6 weeks)
Oxygen saturation
Measurement of oxygen saturation through a pulse oximeter in %. It will be measured before and after each session of hypnosis with recording of maximal value
Time frame: Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).
Auto-hypnosis
Patient will record the number of auto-hypnosis realized between the sessions of hypnosis in an agenda given at the enrollement in the study.
Time frame: From enrollment (T0) to the end of the intervention at 6 weeks
Heart rate
Heart rate ( in beat/min) will be recorded with the help of a pulse oximeter at the finger tip. Maximal value will be recorded after a measurement of 30 seconds.
Time frame: Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).
Respiratory rate
Respiratory rate will be recorded counting the number of breathing in 30 seconds and reported in respiration/min.
Time frame: Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).
Plan to share: 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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