Hypnosis on Breathlessness Mastery in Patients With Persistent Dyspnea

NCT07173348 | Not Yet Recruiting

• 1 other identifier: 2025-00440
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Cancer (With or Without Metastasis); COPD III/IV; Interstitial Lung Disease (ILD); Chronic Heart Failure (CHF); Dyspnea

Keywords

Hypnosis; Persistant dyspnea; Cancer with metastasis; Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease; Chronic Heart Failure; Palliative Care

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to the end of the intervention at 6 weeks.

Secondary Outcomes (6)

• Worst breathlessness on the numerical rating scale (NRS)

  From enrollment (T0) to the end of the intervention at 6 weeks.

• Physical and affective component of dyspnea with the Dyspnea-12 scale

  From enrollment (T0) to the end of the intervention at 6 weeks

• Quality of Life with EQ5D5L

  From enrollment (T0) to the end of the intervention at 6 weeks

• Acceptability

  at the end of the intervention at 6 weeks

• Anxiety an Depression (HADS)

  From enrollment (T0) to the end of the intervention at 6 weeks

Other Outcomes (4)

• Oxygen saturation

  Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).

• Auto-hypnosis

  From enrollment (T0) to the end of the intervention at 6 weeks

• Heart rate

  Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).

Study Arms (2)

Hypnosis

EXPERIMENTAL

3 hypnosis sessions separated by 15 days

Other: Hypnosis

Usual Care

NO INTERVENTION

Usual care

Interventions

Hypnosis OTHER

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.

Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years and
• Primary diagnosis of metastatic cancer, COPD stage at least 3B or E, ILD, or CHF and
• Dyspnea stage NYHA III-IV or mMRC 3-4

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Lancardis Foundation: collaborator

Study Sites (2)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

Location

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Neoplasms; Lung Diseases, Interstitial; Dyspnea; Pulmonary Disease, Chronic Obstructive

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisa Hentsch, Dr med

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Hentsch, Dr med

CONTACT

+41 22 305 66 12; lisa.hentsch@hug.ch

Federica Bianchi, PhD

CONTACT

lisa.hentsch@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the outpatient palliative care consultation

Model Details: Open-label, mono-centric, randomised-controlled trial with a two-arm parallel design

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)