Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea

NCT07637604 | Not Yet Recruiting

• 2 other identifiers: APHP251231N° IDRCB: 2025-A02601-48
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive pulmonary Disease (COPD) is a common progressive disorder characterized by persistent airflow limitation. It is usually caused by exposure to tobacco smoke, toxic particles, or toxic gases. COPD is characterized by cough, sputum production, and dyspnea, which is the cardinal symptom and is included in the criteria for severity. Dyspnea is a major source of suffering and disability, especially when it persists at rest. Despite proper medical treatment, many patients continue to suffer from persistent dyspnea that significantly impairs their daily functioning and quality of life. Complementary approaches such as yoga and relaxation techniques are therefore recommended by some experts. Hypnosis is one of these practices. It has been shown to be effective in the management of both acute and chronic pain and it can abolish several types of experimentally induced dyspnea in healthy volunteers. In adults with COPD, a single hypnosis session has been shown to reduce anxiety immediately, though only temporarily. However, according to a recent retrospective study, a median of three hypnosis sessions increases the distance covered in the 6-minute walk test in COPD patients. The investigators therefore hypothesize that several hypnosis sessions will improve the quality of life of adult outpatients with COPD who suffer from persistent dyspnea. The study plans to recruit 154 patients with severe dyspnea (mMRC(modified Medical Research Council Dyspnea Scale) 3 or 4). They will be randomly assigned to either the experimental group or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The primary outcome of the study will be the evolution of quality of life, assessed 6 weeks after the start of the study as compared to baseline. Secondary outcomes will focus on changes in exercise capacity, dyspnea, anxiety, depression, dyspnea-related catastrophizing, self-efficacy, and pleasure in life.

Conditions

Dyspnea; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Dyspnea,; Hypnosis

Outcome Measures

Primary Outcomes (1)

• Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ)

  Change in the total score of the St. George's Respiratory Questionnaire (SGRQ), which assesses respiration-related quality of life, at 6 weeks after randomization and baseline. The SGRQ is a self-administered questionnaire that assesses three domains: symptoms, activity, and impact on daily life. It permits calculation of a total score from these three domains, reflecting respiration-related quality of life. Study participants will complete this questionnaire at the first visit, the randomization visit (V1), and the final visit (V6). The two visits will take place 6 weeks apart (with an extra week's buffer in case of unexpected delays regarding one of the visits or hypnosis sessions). (Total score ranges from 0 to 100, 0 = no impact of the disease on quality of life, 100 = maximum impact on quality of life.

  6 weeks

Secondary Outcomes (8)

• Change in the three component scores of the SGRQ that assess the quality of life in COPD in terms of symptoms, activity and impact on daily life

  6 weeks

• Change in ability to engage in physical activity

  6 weeks

• Change in dyspnea and its affective, sensory, and emotional dimensions

  6 weeks

• Change in dyspnea in activities of daily living

  6 weeks

• Changes in levels of anxiety and depression

  6 weeks

Study Arms (2)

Hypnosis

EXPERIMENTAL

Five medical hypnosis sessions, each scheduled 7 ± 2 days apart

Behavioral: Hypnosis

control

OTHER

Four standardized telephone calls, made at 7 ± 2 day intervals

Other: standardized telephone calls

Interventions

Hypnosis BEHAVIORAL

Five medical hypnosis sessions, each scheduled 7 ± 2 days apart

Hypnosis

standardized telephone calls OTHER

Four standardized telephone calls, made at 7 ± 2 day intervals

control

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• COPD (any etiology), referred by a pulmonologist and managed according to GOLD 2024 guidelines except for pulmonary rehabilitation that is not required
• Outpatient follow-up
• Residing in Paris or the inner suburbs for centers located within the city limits, or within a 30-minute drive for centers located outside the city limits of Paris.
• Dyspnea rated as mMRC 3 or 4
• Having signed an informed consent form

You may not qualify if:

• Vulnerable individuals (under legal guardianship or curatorship) or deprived of liberty
• Pregnant or breastfeeding women
• Absolute or relative contraindication to the 6 minutes walk test, spirometry or body plethysmography
• Current COPD exacerbation or exacerbation resolved less than one week ago
• Psychosis or other psychiatric disorder likely to interfere with study participation
• Profound hearing impairment
• Cognitive impairment
• Use of psychedelic substances (ex: LSD (Lysergic acid diethylamide), psilocybin, etc.)
• Current participation in interventions that may be related to hypnosis: any kind of meditation, relaxation, sophrology, heart coherence training, yoga, Qi Gong, holotropic breathing, EMDR (Eye Movement Desensitization and Reprocessing) or any psychotherapies involving eye movements, as well as shamanic practices and brief psychotherapies or cognitive-behavioral therapies
• Previous management of dyspnea using hypnosis
• Inability to be reached by phone or teleconsultation
• Lack of health insurance (French social security) coverage
• Participation in another clinical trial
• End of life

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

APHP, Hôpital Pitié-Salpêtrière

Paris, France, 75013, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christian STRAUS, MD,PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian STRAUS, MD, PHD

CONTACT

+331 42 17 85 78; christian.straus@aphp.fr

Marthe MAHI, Master

CONTACT

+331 42 16 16 99; marthe.mahi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 15, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests outside of this time frame may also be considered by the sponsor
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. The decision will be subject to the prior agreement of the sponsor and in compliance with applicable data protection regulations.

Locations

FR (1)