Clinical trial NCT04010825: Impact of Hypnosis Intervention on the Emotional Dimension of Dyspnea in Patients With COPD.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Dyspnea
Pulmonary rehabilitation
Physical activity
Hypnosis
Anxiety
COPD
Lead sponsor: 5 Santé
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the clinical study is to compare the effect of hypnosis intervention on the emotional dimension of the dyspnea during a pulmonary rehabilitation program to the pulmonary rehabilitation program alone. This study will determine if the hypnosis intervention will lead to better maintenance of benefits obtained than the original described method.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Inability to answer a questionnaire
* Patient with psychosis or psychiatric disorders with delusions (or delusions history)
* Pregnant women
* Protected adults
* Participation in another study, with the exception of observational studies

Primary outcomes:
measure: Differential of the emotional dimension of dyspnea 6 months after pulmonary rehabilitation (PR)
timeFrame: Change from baseline (T0) to 6 month follow-up (T2)
Secondary outcomes:
measure: Differential of the emotional dimension of dyspnea from baseline to PR end-stay and from PR end-stay to 6 months after PR
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) and from T1 to 6 month follow-up (T2)
measure: Differential of the impact dimension of dyspnea
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
measure: Differential of the sensory dimension of dyspnea
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
measure: Differential of the post-traumatic stress disorder
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
measure: Differential of the quality of life
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
measure: Differential of the anxiety and depression
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
measure: Differential of the physical activity and sedentarity levels
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
measure: Questionnaire for assessing psychotropic drug quantity and dosage
timeFrame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
measure: Number of exacerbations and hospitalizations
timeFrame: Changes from baseline (T0) to 6 month follow-up (T2)
measure: Hypnosis frequency
timeFrame: Changes from baseline (T0) to 6 month follow-up (T2)
measure: Number of participants with previous hypnosis experiences
timeFrame: Months or/and years before PR baseline (T0)
measure: Self-Hypnosis frequency
timeFrame: Changes from baseline (T0) to 6 month follow-up (T2)
measure: Number of participants with previous self-hypnosis experiences
timeFrame: Months or/and years before PR baseline (T0)
measure: Relaxation methods frequency
timeFrame: Changes from baseline (T0) to 6 month follow-up (T2)
measure: Number of participants with previous relaxation methods experiences
timeFrame: Months or/and years before PR baseline (T0)
Other outcomes:
Locations:
city: Lodève
country: France
facility: Clinique du Souffle la Vallonie
city: Osséja
country: France
facility: Clinique du Souffle la Solane
Study officials:
affiliation: 5 SANTE - Clinique du Souffle la Solane
name: Adriana Castanyer
role: PRINCIPAL_INVESTIGATOR
affiliation: 5 Santé
name: Nelly Heraud, PhD
role: STUDY_DIRECTOR
References: