Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients

Study Overview
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Brief Summary
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The aim of the study is to evaluate, 3 months after lung transplantation, integration and appropriation by the patient of complementary techniques ( Toolbox  included relaxation, autohypnosis, relaxation therapy, TENS (if pain) and holistic gymnastics to improve the comfort and the quality of life in very high-technology care pathway

Detailed Description
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Patients approaching a lung transplant will face specific infectious, immunological, ventilatory and hemodynamic problems but also to painful, stressful and anxiety-provoking situations. Learning different complementary therapies in the pre-transplant period allows patients to have personal tools to improve their comfort before and after the transplant. These tools can be used by patients who have acute or chronic pain symptoms, to support painful examination or care, and for situations of stress and anxiety. The project aims to present different therapies complementary to patients. Before and after transplant, patients benefits of learning and realization sessions of these techniques. They appropriate the techniques and choose the ones that suit best. The overall benefit will be judged comparing period before transplant to period after transplant on different criteria.

Official Title
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Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients

Conditions
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Lung Transplant

Intervention / Treatment
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* Behavioral: Relaxation
* Behavioral: Hypnosis
* Behavioral: Holistic gymnastics
* Device: Transcutaneous electrical nerve stimulation (TENS)
* Behavioral: Sophrology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for a lung transplantation benefiting from a pre-transplant evaluation Exclusion Criteria: transplant patient in emergency delay between pre-transplant evaluation and transplantation over 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung transplant<br>Patients who must undergo a lung transplant at the FOCH hospital. Before and after transplantation, patients benefits of learning and realization sessions of complementary techniques: Relaxation, Hypnosis, Holistic gymnastics, Transcutaneous electrical nerve stimulation (TENS), Sophrology. | Behavioral: Relaxation<br>* Relaxation<br>Behavioral: Hypnosis<br>* Hypnosis<br>Behavioral: Holistic gymnastics<br>* holistic gymnastics<br>Device: Transcutaneous electrical nerve stimulation (TENS)<br>* TENS<br>Behavioral: Sophrology<br>* Sophrology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions of complementary techniques | Number of sessions of complementary techniques practiced by the patient alone and by the patient with an investigator of the team. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implication and satisfaction degree measured by Visual Analogical Scale (VAS) | Implication and satisfaction of the patient regarding the different techniques. Investment, autonomy, conformity to instructions, adaptation to different situation and use of the different techniques are evaluated by the patient and by the investigators using 5 Visual Analogical Scales (VAS) | 3 months | 
| Efficacy of complementary techniques on the pain felt. | Evaluate the efficacy of the toolbox on presence, intensity, location, type of pain 3 months after transplant by VAS, questionnaire DN4 and Kehlet's questionnaire. 3 VAS to measures the intensity of pain on a scale of 0 (no pain) to 10 (worst possible pain), and 1 question to locate the pain. DN4 to identify neuropatic pain: 4 questions to answer by yes or no. yes = 1 point, no = 0 point. Total score ≥ 4/10 = positive test. Kehlet's questionnaire to evaluate the impact of pain on activities. | 3 months | 
| Efficacy of complementary techniques on anxiety and depression level | Evaluate the efficacy of the toolbox on anxiety and depression level 3 months after transplant by Hospital Anxiety and Depression (HAD) scale. 14 items rated from 0 to 3. Seven questions relate to anxiety and seven others to the depression. Two scores (maximum of each score = 21). | 3 months | 
| Efficacy of complementary techniques on stress level | Evaluate the efficacy of the toolbox on stress level 3 months after transplant by Perceived Stress Scale. 10 items rated from 0 to 5. Total score < 21 = someone who knows how to manage stress. Total score between 21 and 26 = someone who usually knows how to manage stress, except in certain situations. Total score > 27 = someone who don't knows how to manage stress. | 3 months | 
| Efficacy of complementary techniques on sleep quality | Evaluate the efficacy of the toolbox on sleep quality 3 months after transplant by Spiegel sleep score. 6 items rated from 0 to 5. More the score is lower, more the sleep disorders is serious. | 3 months | 
| Efficacy of complementary techniques on quality of life | Evaluate the efficacy of the toolbox on quality of life 3 months after transplant by questionnaire Quality of life EuroQol - 5 Dimension (EQ5D) and the EuroQol Visual Analogue scale (EQ VAS) . EQ5D: 5 dimensions. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS: records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Quality of life