Impact of Hypnosis Intervention Focused on the Emotional Dimension of Dyspnea on the Maintenance of Benefits for Patients With COPD After a Pulmonary Rehabilitation: A Multicenter Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Differential of the emotional dimension of dyspnea 6 months after pulmonary rehabilitation (PR)
研究概览
简要总结
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.
详细描述
While physical activity level is the best predictor of life expectancy for patients with chronic obstructive pulmonary disease (COPD), the majority of patients have physical activity levels well below guidelines. One of the main barriers to regular activity is anxiety related to dyspnea. Defined as a subjective experience of discomfort during breathing, dyspnea is described as a multidimensional phenomenon integrating both the impact dimension (daily disability), the sensory dimension (intensity of dyspnea) and the emotional dimension (unpleasant and anxiety-aspects). The most effective treatment to reduce dyspnea is pulmonary rehabilitation. An overall improvement in dyspnea, and more specifically in its emotional dimension, has been achieved by reducing dyspnea anxiety. By reducing one of the major barriers to regular physical activity, the level of post-rehabilitation physical activity should also be improved. However, paradoxically, many studies have reported that there has been no change in the level of physical activity of patients in post-rehabilitation. A possible hypothesis to explain this decoupling between the improvement of the emotional dimension of dyspnea and the absence of behavioral modification, lies in the disappearance of the effects once at home. Indeed, during a pulmonary rehabilitation stay, patients practice under health professionals' supervision and advices with regular feedback on their abilities. When patients return home left on their own again, dyspnea anxiety is likely to reappear and motivation may not be enough.
Several techniques have been proposed to complement traditional interventions in order to strengthen rehabilitation effects. Unfortunately, these are not effective. The use of hypnosis as a complement to rehabilitation programs is a promising perspective to maintain the benefits on the emotional dimension of dyspnea after a rehabilitation program. Its benefits have already been demonstrated in the reduction of acute and chronic pains, in a long-term effectiveness using self-hypnosis techniques. These ensure the continuity of remote management of the intervention. Given the analogy between pain and dyspnea, hypnosis could therefore constitute a therapeutic solution as a complement to rehabilitation to durably reduce dyspnea anxiety in patients with COPD, and promote a better behavior at middle and long term.
The investigators hypothesize that hypnosis used in addition to a 4-week pulmonary rehabilitation program will maintain the benefits on the emotional dimension of dyspnea at 6 months in the experimental group compared to a control group.
The main objective is to evaluate the impact of a hypnosis intervention during a pulmonary rehabilitation program on the emotional dimension of dyspnea 6 months after patients return home (T2).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •40 and 75 years old
- •Reading and writing skills
排除标准
- •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
研究组 & 干预措施
Hypnosis Arm
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.
干预措施: Hypnosis intervention focused on the emotional dimension of the dyspnea (Other)
Control Arm
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.
结局指标
主要结局
Differential of the emotional dimension of dyspnea 6 months after pulmonary rehabilitation (PR)
时间窗: Change from baseline (T0) to 6 month follow-up (T2)
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.
次要结局
- 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 anxiety and depression(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))
- Number of participants with previous self-hypnosis experiences(Months or/and years before PR baseline (T0))
- Relaxation methods frequency(Changes from baseline (T0) 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))
- Number of exacerbations and hospitalizations(Changes from baseline (T0) to 6 month follow-up (T2))
- Differential of the physical activity and sedentarity levels(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))
- Questionnaire for assessing psychotropic drug quantity and dosage(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))
- Hypnosis frequency(Changes from baseline (T0) to 6 month follow-up (T2))
- Self-Hypnosis frequency(Changes from baseline (T0) to 6 month follow-up (T2))
- Number of participants with previous relaxation methods experiences(Months or/and years before PR baseline (T0))
- Number of participants with previous hypnosis experiences(Months or/and years before PR baseline (T0))