Hypnosis on Breathlessness Mastery in Patients With Persistent Dyspnea

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Geneva

About this trial

Persistent dyspnea is a debilitating symptom, that is common and difficult to treat. This symptom is found in many different diseases including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), chronic heart failure (CHF), and metastatic cancer. Dyspnea is associated with many other symptoms, including anxiety, depression, and fatigue and is responsible for a significant reduction in quality of life. To date, only opiates are recommended for the pharmacological treatment of persistent dyspnea.

The effectiveness of hypnosis is well known in the treatment of anxiety and delivered to patients suffering from chronic dyspnea for this reason. One randomised controlled study has shown that a single 20-minute mindfulness sessions could significantly reduce general symptom burden and have a significant impact on anxiety and depression in palliative care patients. Furthermore, the intervention had no negative side effects.

Our aim is to evaluate the effectiveness of three hypnosis sessions on breathlessness mastery in patients with persistent dyspnea, using as a primary outcome the mastery domain of a validated tool, the Chronic Respiratory Questionnaire (CRQ).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥ 18 years and

Primary diagnosis of metastatic cancer, COPD stage at least B or E, ILD, or CHF and

Dyspnea stage NYHA ≥ II or mMRC ≥ 2

Disqualifiers

Have had hypnosis treatment in the last 12 months

Have an estimated life expectancy of less than 6 months

Have participated in pulmonary rehabilitation in the last 6 months

Have been hospitalised in the last month (30 days)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypnosis

    Other intervention

    Participants will undergo three 15-minute individual hypnosis intervention, conducted by a trained hypnotherapist, with a two-week interval between each session. A guide for the session has been developed by two experimented hypnotherapists specifically for this intervention and will be used for all sessions. A total of 3 hypnosis session will be realized.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: HypnosisExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Chronic Respiratory Questionnaire (CRQ): sub scale mastery

The CRQ is a validated 20-item health-related quality of life questionnaire in which experiences are rated on seven-point scales ranging from 1 (maximum impairment) to 7 (no impairment). The CRQ mastery is a domain of the CRQ which comprises four questions with a range of scores also ranging from 1 to 7

Time frame
From enrollment to the end of the intervention at 6 weeks.

Secondary outcomes

1

Worst breathlessness on the numerical rating scale (NRS)

The numerical rating scale (NRS) ranges from 0 (no breathlessness) to 10 (worst breathlessness).

Time frame
From enrollment (T0) to the end of the intervention at 6 weeks.
2

Physical and affective component of dyspnea with the Dyspnea-12 scale

The Dyspnea-12 (D-12) scale is a tool to help to assess the dyspnea. Dyspnea is a multidimensional symptom, comprising physical (intensity, location, temporality and sensory quality) and affective (unpleasant) sensations. This D-12 questionnaire is a dyspnea assessment tool. It contains 12 items. The first 7 items correspond to the evaluation of the sensory aspect and the next 5 to the evaluation of the affective aspect. The higher is the score the higher is the burden of dyspnea.

Time frame
From enrollment (T0) to the end of the intervention at 6 weeks
3

Quality of Life with EQ5D5L

The EQ-5D-5L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient own judgement.

Time frame
From enrollment (T0) to the end of the intervention at 6 weeks
4

Acceptability

Acceptability will be evaluate at the end of the 3 hypnosis session. with the help of a Lickert scale: completely agree, agree, neutral, don't agree, completely disagree.

Time frame
at the end of the intervention at 6 weeks

Other outcomes

1

Oxygen saturation

Measurement of oxygen saturation through a pulse oximeter in %. It will be measured before and after each session of hypnosis with recording of maximal value

Time frame
Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).
2

Auto-hypnosis

Patient will record the number of auto-hypnosis realized between the sessions of hypnosis in an agenda given at the enrollement in the study.

Time frame
From enrollment (T0) to the end of the intervention at 6 weeks
3

Heart rate

Heart rate ( in beat/min) will be recorded with the help of a pulse oximeter at the finger tip. Maximal value will be recorded after a measurement of 30 seconds.

Time frame
Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).
4

Respiratory rate

Respiratory rate will be recorded counting the number of breathing in 30 seconds and reported in respiration/min.

Time frame
Before and after hypnosis sessions (which will take place at 2,4 and 6 weeks after enrollement).

Sponsors and contacts

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University Hospital, Geneva

Lead sponsor

Lancardis Foundation

Collaborator