Effectiveness of Hypnosis on Breathlessness Mastery in Patients With Persistent Dyspnea: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Chronic Respiratory Questionnaire (CRQ): sub scale mastery
研究概览
简要总结
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).
详细描述
Hypnosis is currently used to reduce anxiety in patients with breathlessness. Although a reduction in anxiety has been correlated with a reduction in dyspnea, the effectiveness of hypnosis on breathlessness self-management has not yet been evaluated. As medical options for the treatment of chronic persistent breathlessness are limited, finding new, innovative ways, to help patients feel more confident in the management of their dyspnea should be a priority. Some interventions such as pulmonary rehabilitation, the hand-held fan and walking aids have been proven to be effective. However, patients with advance disease may not be well enough to endure physical interventions such as pulmonary rehabilitation.
Hypnosis has been shown to be safe and to diminish anxiety in patients suffering from Chronic Obstructive pulmonary disease (COPD). The risk linked to hypnosis is considered minimal as participants may interrupt the hypnosis session at any time and there are no known side effects to hypnosis. Additionally, patients could benefit from the proven reduction of anxiety. The benefits for patients clearly outweigh the risks.
The objective of this prospective parallel randomised controlled trial is to determine the effectiveness of hypnosis on breathlessness mastery in patients with persistant dyspnea and advanced disease. The primary endpoint is the patient-reported breathlessness mastery as measured with the mastery subscale of the Chronic Respiratory Questionnaire (CRQ) after three hypnosis sessions.
Participants will undergo three 15-minute individual hypnosis intervention, conducted by a trained hypnotherapist, with a two-week interval between each session. A guide has been developed by two experimented hypnotherapists specifically for this intervention and will be used for all sessions. The control group will undergo usual care (no hypnosis).
Participants will be recruited at the outpatient consultations of cardiology, pneumology, oncology, primary care and palliative care of the Geneva University Hospital (single centre) by their treating physician. All eligible participants will be presented with the objectives of the study, the procedures involved, the timing of the intervention and will receive an information sheet about the study. Eligible participants will be contacted by a research associate in the following days. If they consent to participate, participants will be randomised to receive either the intervention (3 hypnosis sessions) or usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Are unable to come to the hospital for 3 outpatient consultations (1 every two weeks)
- •Have a condition that would interfere with their ability to respond to the questionnaires (i.e. cognitive impairment, hearing impairment, etc.)
- •Are not eligible for a hypnosis session due to a psychiatric disorder
研究组 & 干预措施
Usual Care
Usual care
Hypnosis
3 hypnosis sessions separated by 15 days
干预措施: Hypnosis (Other)
结局指标
主要结局
Chronic Respiratory Questionnaire (CRQ): sub scale mastery
时间窗: From enrollment to the end of the intervention at 6 weeks.
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
次要结局
- Quality of Life with EQ5D5L(From enrollment (T0) to the end of the intervention at 6 weeks)
- Worst breathlessness on the numerical rating scale (NRS)(From enrollment (T0) to the end of the intervention at 6 weeks.)
- Anxiety an Depression (HADS)(From enrollment (T0) to the end of the intervention at 6 weeks)
- Acceptability(at the end of the intervention at 6 weeks)
- Physical and affective component of dyspnea with the Dyspnea-12 scale(From enrollment (T0) to the end of the intervention at 6 weeks)
- Duration of hypnosis sessions(After each hypnosis sessions (at 2, 4 and 6 weeks))
研究者
Lisa Hentsch
Head of the outpatient palliative care consultation
University Hospital, Geneva