Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program

NCT04868357 | Completed

• 1 other identifier: HYPNOBPCO_2
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) are prone to breathlessness, chest tightness and other anxiety-inducing symptoms. Medical therapy for the condition focus on improving these symptoms and preventing exacerbations. However, as the disease progresses, pharmacological therapies become less and less effective. Patients with advanced COPD often feel less benefit from the treatment in terms of relief from their symptoms and relief from anxiety about their breathing. Hypnosis is known to induce immediate changes in how a person thinks and experiences their body. These changes can break vicious cycles of anxiety. Hypnosis has already been used successfully people with breathing problems to reduce anxiety and improve breathing. This trial aims to investigate the effect of hypnosis as a complementary technique for the self-management of breathlessness and anxiety during a Pulmonary Rehabilitation Program (PRP). As a secondary measure, the investigators aim to uncover whether the use of self-hypnosis remains useful during the three months following the PRP, after discharge from hospital.

Conditions

COPD; Dyspnea; Anxiety

Keywords

COPD; Dyspnea; Anxiety; Depression; Hypnosis

Outcome Measures

Primary Outcomes (3)

• Change in anxiety scores

  Anxiety, as determined by the State-Trait Anxiety Inventory (6 item version, STAI-6). This scale rates anxiety with a score between 20 and 80 points. The cutoff score for a clinical anxiety diagnosis is 39 points. Lower scores mean lower anxiety levels.

  Baseline (inclusion in PRP, Week 1). Week 2. Week 3. Week 4 (PRP completion). After finishing the PRP, once a month for 3 months.

• Change in anxiety & depression scores

  Anxiety, as determined by the Hospital Anxiety and Depression inventory (HADS). This scale rates anxiety and depression tendencies with a score between 0 and 21. The cutoff score for a clinical mild anxiety diagnosis is 8-10 points. Lower scores mean lower anxiety and depression levels.

  Baseline (inclusion in PRP, Week 1). Week 4 (PRP completion).

• Change in anxiety and quality of life scores

  Anxiety and quality of life as measured by the Multidimensional Dyspnea Profile. The MDP consists of 11 items divided into three domains (discomfort breathing by intensity, discomfort breathing by description, anxiety and distress coming from breathing difficulties). In all domains, intensity is rated from 0 (negligible) to 10 (worst possible condition). In the second domain in particular, the respondent selects between five descriptors the one that better represents their breathing discomfort, and then rates its intensity. Lower levels mean less discomfort and better quality of life.

  Baseline (inclusion in PRP, Week 1). Week 4 (PRP completion).

Secondary Outcomes (5)

• 6-minute walking test

  Baseline (inclusion in PRP, Week 1). Week 4 (PRP completion).

• COPD Assesment Test (CAT)

  Baseline (inclusion in PRP, Week 1). Week 4 (PRP completion). After finishing the PRP, once a month for 3 months.

• Re-hospitalisation rate

  After finishing the PRP, once a month for 3 months.

• Use of self-hypnosis techniques

  A measure completed by the patient throughout the PRP up to 4 weeks. Then once a month after finishing the PRP for 3 months.

• Action Plan

  Once a month after finishing the PRP, for 3 months.

Other Outcomes (2)

• Smoking status.

  Baseline (inclusion in PRP, Week 1). Week 4 (PRP completion). Once a month after finishing the PRP, for 3 months.

• Psychoactive drug intake

  Baseline (inclusion in PRP, Week 1). Week 4 (PRP completion). Once a month after finishing the PRP, for 3 months.

Study Arms (2)

Hypnosis

EXPERIMENTAL

Delivered twice during the 4-week PRP program (weeks 1,3). It consists of 45-minute sessions of group hypnosis. It includes 1 hypnotic induction, multiple suggestions of relaxation and a feeling of air entering the lungs, and a closing exercise. The intervention includes a prescription to use these exercises freely throughout the PRP, as a tool for self-managing discomfort and inducing calmness. This arm is structured following the classic format of didactic hypnosis interventions, were patients discover the exercise by doing it, and receive keys to be able to recreate the hypnotic state on their own.

Behavioral: Hypnosis

Relaxation

ACTIVE COMPARATOR

Delivered twice during the 4-week PRP program (weeks 1,3). It consists of 45-minute sessions of group dynamic relaxation. It includes 1 exercise to liberate tension, 3 exercises to increase proprioception and calmness, and 3 exercises for calming and regulating the breath. The intervention includes a prescription to use these exercises freely throughout the PRP, as a tool for self-managing discomfort and inducing calmness. 1. Provides additional care that motivates the patients to participate in the control group. 2. Allows the controlling of number of group interventions accross arms (2). 3. Allows to control for motivation, as both arms are introduced identically: the benefits and interest of using self-relaxation techniques for complementary care in anxiety and anxiety-related dyspnea are underscored. 4. It allows the disentanglement of hypnosis and relaxation effects . This was crucial, inasmuch as hypnosis too includes physical relaxation and breathing exercises.

Behavioral: Relaxation

Interventions

Hypnosis BEHAVIORAL

Two 45-minute group sessions in which patients experience hypnosis and learn how to use it for the self-management of anxiety and anxiety-related dyspnea. First session is introductory. Second session addresses concerns that patients may have identified after using self-hypnosis. Both sessions include group hypnosis exercises. Both sessions are to be administered in an identical manner, and require the same motor and communication responses from the patient (i.e., concentrate on the practitioner's voice, eye closure, relaxation, nodding). Patients are asked to concentrate in nature-themed metaphors and hypnotic suggestions of pure air entering their lungs. Both sessions end with a round of questions, instructions and motivation to use self-hypnosis throughout the duration of the PRP and beyond.

Hypnosis

Relaxation BEHAVIORAL

Two 45-minute group sessions in which patients experience dynamic relaxation and learn how to use it for the self-management of anxiety and anxiety-related dyspnea. Both sessions include group relaxation exercises. Both sessions are to be administered in an identical manner, and require the same motor and communication responses from the patient (i.e., concentrate on the practitioner's voice, stretching, breathing exercises, nodding). Both sessions end with a round of questions, instructions and motivation to use relaxation throughout the duration of the PRP and beyond.

Relaxation

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \> 30.
• Affiliated to a Social Security scheme or beneficiary of such a scheme.
• Absence of cognitive disease questioning the validity of patient reported outcomes
• Ability to give free, informed consent.
• Adult patients with severe COPD, dyspnea ; with distension.
• Hospitalized at the CHB.
• Predicted FEV1 and FEV/FVC percentages consistent with severe COPD according to GOLD standards.
• Modified Research Council Questionnaire ≥2
• Exposure to tobbacco \>= 10 packs/yrs.

You may not qualify if:

• Pregnancy
• Known severe cardiac insufficiency.
• Known severe pulmonary arterial hypertension.
• Evolutive-cancer diagnosis.
• Significant cognitive impairment, hypercapnic encephalopathy or confusional syndrome.
• Deafness.
• Anemia ≤ 8g/dL.
• Psychotic pathology.

Sponsors & Collaborators

• Centre Hospitalier de Bligny: lead

Study Sites (1)

Centre Hospitalier de Bligny

Briis-sous-Forges, Briis-sous-Forges, France, France

Location

Related Publications (18)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Anxiety Disorders; Depression

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; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• François Larue, MD

  Centre Hospitalier de Bligny

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 30, 2021
• Study Start: September 27, 2021
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available upon request for the 10 years after the publication of the study
• Access Criteria: The Centre Hospitalier de Bligny will only share the data to inquirers capable of respecting the conditions established by the Commission Nationale de l'Informatique et des Libertés for data protection (CNIL, https://www.cnil.fr/).

Locations

FR (1)