Impact of Hypnosis Intervention on the Emotional Dimension of Dyspnea in Patients With COPD.

NCT04010825 | Completed

• 1 other identifier: DYSPNEMO
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Dyspnea; Pulmonary rehabilitation; Physical activity; Hypnosis; Anxiety; COPD

Outcome Measures

Primary Outcomes (1)

• Differential of the emotional dimension of dyspnea 6 months after pulmonary rehabilitation (PR)

  Assessing differential of the emotional dimension of dyspnea score on the Multidimensional Dyspnea Profile scale (MDP questionnaire Meek et al 2012) 6 months after pulmonary rehabilitation (PR). MDP is a 11 items questionnaire. Each item is graded 0-10. 5 items are devoted to the emotional dimension of dyspnea. High scores indicate high prevalence of symptoms. As proposed by Morélot-Panzini et al in 2016, for filling it up, patient will be asked to focus on his worst dyspnea experience that happened oin the last two weeks.

  Change from baseline (T0) to 6 month follow-up (T2)

Secondary Outcomes (15)

• Differential of the emotional dimension of dyspnea from baseline to PR end-stay and from PR end-stay to 6 months after PR

  Changes from baseline (T0) to at the end of the 4-weeks PR (T1) and from T1 to 6 month follow-up (T2)

• Differential of the impact dimension of dyspnea

  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)

• Differential of the sensory dimension of dyspnea

  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)

• Differential of the post-traumatic stress disorder

  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)

• Differential of the quality of life

  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)

Study Arms (2)

Hypnosis Arm

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.

Other: Hypnosis intervention focused on the emotional dimension of the dyspnea

Control Arm

NO INTERVENTION

In parallel with an inpatient pulmonary rehabilitation program, no additional intervention will be carry out and four visits will be carried out : * V0 : an inclusion visit * V1 : a randomization visit * V7 : a end-stay visit * V8 : a 6-month post-rehabilitation visit ( by phone call) 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.

Interventions

Hypnosis intervention focused on the emotional dimension of the dyspnea OTHER

Individual hypnosis sessions will be for 1 hour. Each hypnosis session will be standardized and evaluated using a script and an observation grid ( Visual Analogic Scale comfort, patient's hypnotic state...) written in collaboration with experts from Institut Milton Hyland Erickson Toulouse France (IMHETO).

Hypnosis Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• and 75 years old
• Reading and writing skills

You may not qualify if:

• 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

Sponsors & Collaborators

• 5 Santé: lead

Study Sites (2)

Clinique du Souffle la Vallonie

Lodève, 34700, France

Location

Clinique du Souffle la Solane

Osséja, 66340, France

Location

Related Publications (1)

• Fernandes N, Alexandre F, Molinier V, Castanyer A, Moine E, Heraud N. Effect of dyspnoea-oriented hypnosis as an adjunct to pulmonary rehabilitation on the affective dimension of dyspnoea and physical activity level: a randomised controlled trial. ERJ Open Res. 2026 Feb 2;12(1):00621-2025. doi: 10.1183/23120541.00621-2025. eCollection 2026 Jan.

  PMID: 41635580 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity; Anxiety Disorders

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; Behavior; Mental Disorders

Study Officials

• Adriana Castanyer

  5 SANTE - Clinique du Souffle la Solane

  PRINCIPAL INVESTIGATOR

• Nelly Heraud, PhD

  5 Santé

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 8, 2019
• Study Start: October 25, 2019
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)