Completado

Impact of Hypnosis Intervention Focused on the Emotional Dimension of Dyspnea on the Maintenance of Benefits for Patients With COPD After a Pulmonary Rehabilitation: A Multicenter Randomized Controlled Clinical Study

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Hypnosis intervention focused on the emotional dimension of the dyspnea

Otro
Quiénes están siendo reclutados

Trastornos de Ansiedad+9

+ Disnea

+ Trastornos Mentales

De 40 a 75 años
+9 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Cuidados de Apoyo

Intervencional
Inicio del estudio: octubre de 2019
Ver detalles del protocolo

Resumen

Patrocinador Principal5 Santé
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 25 de octubre de 2019

Fecha en la que se inscribió al primer participante.

While physical activity level is the best predictor of life expectancy for patients with chronic obstructive pulmonary disease (COPD), the majority of patients have physical activity levels well below guidelines. One of the main barriers to regular activity is anxiety related to dyspnea. Defined as a subjective experience of discomfort during breathing, dyspnea is described as a multidimensional phenomenon integrating both the impact dimension (daily disability), the sensory dimension (intensity of dyspnea) and the emotional dimension (unpleasant and anxiety-aspects). The most effective treatment to reduce dyspnea is pulmonary rehabilitation. An overall improvement in dyspnea, and more specifically in its emotional dimension, has been achieved by reducing dyspnea anxiety. By reducing one of the major barriers to regular physical activity, the level of post-rehabilitation physical activity should also be improved. However, paradoxically, many studies have reported that there has been no change in the level of physical activity of patients in post-rehabilitation. A possible hypothesis to explain this decoupling between the improvement of the emotional dimension of dyspnea and the absence of behavioral modification, lies in the disappearance of the effects once at home. Indeed, during a pulmonary rehabilitation stay, patients practice under health professionals' supervision and advices with regular feedback on their abilities. When patients return home left on their own again, dyspnea anxiety is likely to reappear and motivation may not be enough. Several techniques have been proposed to complement traditional interventions in order to strengthen rehabilitation effects. Unfortunately, these are not effective. The use of hypnosis as a complement to rehabilitation programs is a promising perspective to maintain the benefits on the emotional dimension of dyspnea after a rehabilitation program. Its benefits have already been demonstrated in the reduction of acute and chronic pains, in a long-term effectiveness using self-hypnosis techniques. These ensure the continuity of remote management of the intervention. Given the analogy between pain and dyspnea, hypnosis could therefore constitute a therapeutic solution as a complement to rehabilitation to durably reduce dyspnea anxiety in patients with COPD, and promote a better behavior at middle and long term. The investigators hypothesize that hypnosis used in addition to a 4-week pulmonary rehabilitation program will maintain the benefits on the emotional dimension of dyspnea at 6 months in the experimental group compared to a control group. The main objective is to evaluate the impact of a hypnosis intervention during a pulmonary rehabilitation program on the emotional dimension of dyspnea 6 months after patients return home (T2).

Título OficialImpact of Hypnosis Intervention Focused on the Emotional Dimension of Dyspnea on the Maintenance of Benefits for Patients With COPD After a Pulmonary Rehabilitation: A Multicenter Randomized Controlled Clinical Study
NCT04010825
Patrocinador Principal5 Santé
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 106 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Cuidados de Apoyo

Estos estudios exploran maneras de mejorar el confort y la calidad de vida diaria de las personas que viven con una condición. Pueden centrarse en aliviar síntomas, reducir efectos secundarios del tratamiento o apoyar el bienestar general.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 40 a 75 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos de AnsiedadDisneaTrastornos MentalesEnfermedad CrónicaEnfermedades del pulmónEnfermedades Pulmonares ObstructivasProcesos PatológicosTrastornos de la respiraciónEnfermedades del Tracto RespiratorioSignos y SíntomasSignos y Síntomas RespiratoriosCondiciones Patológicas, Signos y Síntomas

Criterios

4 criterios de inclusión requeridos para participar
Admitted for a 4-week inpatient pulmonary rehabilitation program

COPD diagnosis with a value of the first second of forced expiration (FEV1) < 80% of theoretical values

40 and 75 years old

Reading and writing skills

5 criterios de exclusión impiden participar
Inability to answer a questionnaire

Patient with psychosis or psychiatric disorders with delusions (or delusions history)

Pregnant women

Protected adults

Mostrar Más Criterios

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
In parallel with an inpatient pulmonary rehabilitation program, nine visits will be carried out : * V0 : an inclusion visit * V1 : a randomization visit * V2 to V6 : five visits with hypnosis sessions * V7 : a end-stay visit * V8 : a 6-month post-rehabilitation visit ( by phone call) The five hypnosis sessions (V2 to V6) will be spread over three weeks of rehabilitation program (1 to 2 hypnosis sessions per week). For V1, V7 and V8 : questionnaires will be filled about : quality of life (CAT questionnaire), the three dimensions of dyspnea (mMRC, LCADL and MDP questionnaires), anxiety and depression (HADS questionnaire), post-traumatic stress ( PCLS questionnaire), sedentarity and physical activity (SIMPAQ questionnaire). Other data will be also collected on : previous experiences with hypnosis, self-hypnosis and relaxation, number of exacerbations and hospitalizations in the past 6 months, drug treatment, psychotropic drug use and dosage and psychological follow-up.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 2 ubicaciones

Suspendido

Clinique du Souffle la Vallonie

Lodève, FranceAbrir Clinique du Souffle la Vallonie en Google Maps
Suspendido

Clinique du Souffle la Solane

Osséja, France
Completado2 Centros de Estudio
Impact of Hypnosis Intervention Focused on the Emotional Dimension of Dyspnea on the Maintenance of Benefits for Patients With COPD After a Pulmonary Rehabilitation: A Multicenter Randomized Controlled Clinical Study | PatLynk