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

5 giugno 2026 aggiornato da: Assistance Publique - Hôpitaux de Paris

Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea: a Multicenter Randomized Controlled Trial

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study aims at assessing the effect of medical hypnosis on the quality of life of dyspneic COPD outpatients. It plans to recruit 154 COPD outpatients with severe dyspnea (mMRC 3 or 4). They will have to be treated in accordance with the GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2024 guidelines, exept for pulmonary rehabilitation that is not required. Inclusion and non-inclusion criteria are provided below. Patients will be randomly assigned to either the experimental 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 objectives of the study will be assessed 6 weeks after enrollment. The primary objective of this study will be to evaluate the benefit of hypnosis in improving the quality of life of outpatients with COPD and persistent dyspnea, compared to a control group that will receive support through standardized telephone calls but no hypnosis.

The primary outcome will be the change in the total score of the St George's Respiratory Questionnaire (SGRQ) which assesses respiratory related quality of life, measured 6 weeks after randomization.

The secondary objectives of the study will be to evaluate the benefit of hypnosis in patients with COPD and persistent dyspnea compared to the control group on the following outcomes:

  1. The components of quality of life in COPD: symptoms, activity, and impact on daily life. Those components are part of the SGRQ.
  2. The ability to engage in physical activity. It will will be assessed with the 6-min walk test.
  3. Dyspnea and its affective, sensory, and emotional dimensions. They will be assessed using the multidimensional dypnea profile (MDP) questionnaire. d) Dyspnea in activities of daily living. It will be assessed using the London Chest Activity of Daily Living (LCADL) scale.

e) The level of anxiety. It will be assessed using the Hospital Anxiety and Depression Scale (HADS).

f) The level of depression. It will also be assessed using the Hospital Anxiety and Depression Scale (HADS).

g) The level of catastrophizing about dyspnea. It will be assessed using the breathlessness catastrophizing scale for chronic obstructive pulmonary disease.

h) The level of self-efficacy. It will be assessed using the COPD Self-Efficacy Scale.

i) The level of pleasure (or the level of anhedonia). It will be assessed using the Snaith-Hamilton Pleasure Scale.

Tipo di studio

Interventistico

Iscrizione (Stimato)

154

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Francia
    • France
      • Paris, France, Francia, 75013
        • APHP, Hôpital Pitié-Salpêtrière
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Ongoing pulmonary rehabilitation (physiotherapy outside a structured rehabilitation program initiated before study inclusion is not an exclusion criterion)
  • Inability to be reached by phone or teleconsultation
  • Lack of health insurance (French social security) coverage
  • Participation in another clinical trial
  • End of life

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Hypnosis
Five medical hypnosis sessions, each scheduled 7 ± 2 days apart
Comportamentale: Hypnosis
Five medical hypnosis sessions, each scheduled 7 ± 2 days apart
Altro: control
Four standardized telephone calls, made at 7 ± 2 day intervals
Altro: standardized telephone calls
Four standardized telephone calls, made at 7 ± 2 day intervals

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ)
Lasso di tempo: 6 weeks
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 6 weeks
The SGRQ permits the calculation of 3 scores related to the quality of life in COPD patients : symptoms, activity and impact on daily life (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
Change in ability to engage in physical activity
Lasso di tempo: 6 weeks
Distance covered during the 6-minute walk test
6 weeks
Change in dyspnea and its affective, sensory, and emotional dimensions
Lasso di tempo: 6 weeks
Dyspnea will be assessed using the Multidimensional Dyspnea Profile (MDP) questionnaire (Scores range from 0 to 10-50 for each item with higher scores indicating more severe sensory or emotional dyspnea; 0 = no impact of breathlessness.).
6 weeks
Change in dyspnea in activities of daily living
Lasso di tempo: 6 weeks
Dyspnea will be assessed using the London Chest Activity of Daily Living (LCADL) scale (Scores range from 0 to 75, 0 = no limitation of daily activities due to breathlessness. 75 = maximum limitation of daily activities due to breathlessness.).
6 weeks
Changes in levels of anxiety and depression
Lasso di tempo: 6 weeks
The levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) (Scores range from 0 to 21 for each subscale, with higher scores indicating more severe anxiety or depressive symptoms, 0-7 = Normal, 11-21 = Probable case of anxiety/depression).
6 weeks
Change in level of catastrophizing about dyspnea
Lasso di tempo: 6 weeks
The level of catastrophizing about dyspnea will be assessed using the breathlessness catastrophizing scale (Scores range from 0 to 52, A score of 0 indicates no catastrophizing, whereas a score of 52 indicates maximal catastrophizing) for chronic obstructive pulmonary disease
6 weeks
Change in level of self-efficacy in COPD
Lasso di tempo: 6 Weeks
The level of self-efficacy will be assessed using the COPD Self-Efficacy Scale (Scores range from 34 to 170, 34= lowest perceived self-efficacy, 170= greatest perceived self-efficacy).
6 Weeks
Change in level of pleasure (or the level of anhedonia)
Lasso di tempo: 6 weeks
The level of pleasure will be assessed using the Snaith-Hamilton Pleasure Scale (Scores range from 0 to 14, 0 = no anhedonia, 14= greatest anhedonia or lowest experienced pleasure).
6 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigatori

  • Investigatore principale: Christian STRAUS, MD,PHD, Assistance Publique - Hôpitaux de Paris

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 ottobre 2029

Completamento dello studio (Stimato)

15 dicembre 2029

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • APHP251231
  • N° IDRCB: 2025-A02601-48 (Altro identificatore: ANSM)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Due to the procedures approved by the French data privacy authority (Commission nationale de l'informatique et des libertés - CNIL), and the content of the informed consent forms signed by participants, full database transmission is not authorized.

However, consultation of deidentified individual participant data may be considered for editorial boards or qualified researchers, upon reasonable request and under strict regulatory safeguards, subject to prior agreement on terms and conditions of access.

Periodo di condivisione IPD

Beginning 3 months and ending 3 years following article publication. Requests outside of this time frame may also be considered by the sponsor

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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