Condition category
Respiratory
Date applied
19/12/2019
Date assigned
07/01/2020
Last edited
12/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with chronic obstructive pulmonary disease (COPD) are prone to asthma-like wheezing, breathlessness, chest tightness and other anxiety-inducing symptoms. Drug treatments for the condition focus on improving these symptoms and preventing exacerbations (short periods where the disease becomes much worse). However, as the disease progresses, the drugs stop working as effectively as previously. Patients with advanced COPD and those who are dying often feel less benefit from the treatment in terms of relief from their symptoms and relief from anxiety about their breathing. This lack of relief can worsen their illness over time. 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 on breathlessness and anxiety in severe and dying COPD patients.

Who can participate?
Patients who suffer from severe COPD, already admitted at the Bligny Hospital Center (CHB)

What does the study involve?
Each participant will receive a 15-min session of hypnosis and a 15-min session of active listening in a random order. Active listening involves the therapist reading aloud and the participant will be encouraged to pay attention and visualize the images that are being described. Participants will have their anxiety level, breathing rate and blood oxygen level measured before and after each session.

What are the possible benefits and risks of participating?
The risks are minimal because hypnosis poses no real threat or adverse effects to a person's mental or physical health. As long as people accept 15 minutes of 'playing the game', it should make them relax and feel good. The same applies to active listening.

Where is the study run from?
Bligny Hospital Center (France)

When is the study starting and how long is it expected to run for?
September 2017 to January 2020

Who is funding the study?
Bligny Hospital Center (France), Fondation pour les Soins Palliatifs (France) and the Japanese Society for the Promotion of Science (JSPS)

Who is the main contact?
Dr François Larue, head of the Palliatve Care Unit at the CHB, flarue@chbligny.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hernan Anllo

ORCID ID

https://orcid.org/0000-0002-1663-1881

Contact details

Watanabe Cognitive Science Laboratory
School of Fundamental Science and Engineering
Rm 407-1B
59th Bldg
Waseda University
3-4-1 Ohkubo
Shinjuku
Tokyo
2110063
Japan
+81 7018205004
subcomarc@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019-A02016-51, NTS 19.07.16.35413.

Study information

Scientific title

Hypnosis for management of breathlessness and anxiety in severe and palliative-care COPD patients: a sham-controlled crossover trial

Acronym

HYPNOBPCO_1

Study hypothesis

Hypnosis constitutes a non-drug complementary procedure capable of diminishing subjective feelings of breathlessness and anxiety, while improving patient’s awareness and subjective appreciation of their breathing mechanics. We posit that hypnosis will diminish anxiety in severe and terminal COPD patients, improving their breathing and quality of life (QoL).

Ethics approval

Approved 07/11/2019, Comité de Protection des Personnes Ile de France 1 (Hôtel-Dieu-1, Place du Parvis Notre-Dame, 75181, Paris, France; +33 (0)1 42 34 80 52; cpp.iledefrance1@htd.aphp.fr/cppiledefrance1@orange.fr), ref: CPPIDF1-2019-ND75






Study design

Randomized sham-controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See addition files for information sheet in French.

Condition

Dyspnea (breathlessness) in patients with severe chronic obstructive pulmonary disease (COPD)

Intervention

Treatment: Hypnosis (15-minute script, available on request)
Sham: Active listening session (15-minute script, available on request)

6-week, randomized, sham-controlled, crossover, non-drug interventional study conducted at the Bligny Hospital Center in Briis-sous-Forges, France. Patients underwent two 15-minute individual interventions, hypnosis (A) and sham (B), in randomly assigned order (AB or BA), with a 24-h washout period between sessions.

20 COPD patients (mean FEV1/FVC <0.7) underwent two 15-minute individual sessions, Active Listening and Hypnosis, in the form of a crossover trial with a 24-h washout period. A total of 4 pairs of investigators (medical practitioners specialized in pneumonology and/or palliative care, trained in hypnotherapy) are charged with administering both sessions and obtaining patient data. Session order and assignment of investigator pair (Mp1, Mp2, Mp3 or Mp4) are counterbalanced across patients, so that in a random fashion:
1. Approximately half of the sample goes through Active Listening first and Hypnosis second, and approximately the other half goes through Hypnosis first and Active Listening second.
2. Each pair of experimenters is in charge of testing at least one patient belonging to the first half, and one patient belonging to the second half.
3. No prior clinical relationship shall exist between patients and medical practitioners.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Anxiety assessed using the STAI-6 questionnaire at baseline and immediately after intervention

Secondary outcome measures

1. Respiratory rate in cycles/min measured manually, following the accepted standard procedure, at baseline and immediately after intervention
2. Oxygen saturation (SpO2) measured with a pulse oximeter at baseline and immediately after intervention

Overall trial start date

01/09/2017

Overall trial end date

20/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 35-80 years
2. Affiliated to a Social Security scheme or beneficiary of such a scheme
3. Absence of neurological disease interfering with the passing of tests
4. Capable of giving free, informed consent.
5. Severe COPD with dyspnea and distension
6. Hospitalized, with or without a tracheotomy
7. Non-obese
8. Predicted FEV1 <60% and FEV/FVC <70%, with distension evidenced by chest x-ray or predicted TLC >120% in pulmonary function tests
9. Severity marked by ongoing hospitalization, with at least one prior instance of decompensation
10. Dyspneic, with resting Borg Scale score ≥3
11. Not having yet participated in the complementary care protocol offered by the hospital, a pulmonary rehabilitation program (PRP) protocol, or any hypnosis protocol

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Pregnancy
2. Mechanical ventilation during the session
3. Known severe cardiac insufficiency
4. Known severe pulmonary arterial hypertension
5. Cancer diagnosis
6. Significant cognitive impairment, hypercapnic encephalopathy or confusional syndrome
7. Deafness
8. Anemia (hemoglobin ≤8 g/dl)
9. Psychotic pathology
10. Anti-epileptic treatment

Recruitment start date

10/12/2019

Recruitment end date

18/02/2020

Locations

Countries of recruitment

France

Trial participating centre

Bligny Hospital Center
Rue de Bligny Briis-sous-Forges
Paris
91640
France

Sponsor information

Organisation

Bligny Hospital Center

Sponsor details

Rue de Bligny
Briis-sous-Forges
Paris
91640
France
+33 1 69 26 30 02
jb.meric@chbligny.fr

Sponsor type

Hospital/treatment centre

Website

http://www.chbligny.fr/

Funders

Funder type

Hospital/treatment centre

Funder name

Centre Hospitalier de Bligny

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Japanese Society for the Promotion of Science (JSPS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fond pour les Soins Palliatifs

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We expect submission to international peer-reviewed publications as soon as the first draft is ready, with local and international press releases if publication is successful.
Additional dissemination strategies will be put in place by the Fondation pour les Soins Palliatifs (France) once the trial is finished.

IPD sharing statement:
The datasets generated and/or analysed during this study will be made public alongside the results publication.

Intention to publish date

28/02/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/02/2020: The overall trial end date has been changed from 18/02/2020 to 20/02/2020. 11/02/2020: The following changes have been made: 1. The recruitment end date has been changed from 18/01/2020 to 18/02/2020. 2. The overall trial end date has been changed from 31/01/2020 to 18/02/2020. 07/01/2020: The participant information sheet has been uploaded. 23/12/2019: Trial's existence confirmed by Comité de Protection des Personnes Ile de France 1.