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

Not Applicable

Completed

• Conditions: Lung Transplant
• Interventions: Behavioral: Relaxation; Behavioral: Hypnosis; Behavioral: Holistic gymnastics; Device: Transcutaneous electrical nerve stimulation (TENS); Behavioral: Sophrology

• Registration Number: NCT03167528
• Lead Sponsor: Hopital Foch

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-05-03
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Primary Completion: 2020-09-03
• Study Completion: 2020-09-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Candidates for a lung transplantation benefiting from a pre-transplant evaluation

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Exclusion Criteria

• transplant patient in emergency
• delay between pre-transplant evaluation and transplantation over 12 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung transplant	Hypnosis	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.
Lung transplant	Holistic gymnastics	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.
Lung transplant	Relaxation	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.
Lung transplant	Sophrology	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.
Lung transplant	Transcutaneous electrical nerve stimulation (TENS)	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.

Primary Outcome Measures

Name	Time	Method
Number of sessions of complementary techniques	3 months	Number of sessions of complementary techniques practiced by the patient alone and by the patient with an investigator of the team.

Secondary Outcome Measures

Name	Time	Method
Efficacy of complementary techniques on stress level	3 months	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.
Implication and satisfaction degree measured by Visual Analogical Scale (VAS)	3 months	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)
Efficacy of complementary techniques on anxiety and depression level	3 months	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).
Efficacy of complementary techniques on sleep quality	3 months	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.
Efficacy of complementary techniques on quality of life	3 months	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'.
Efficacy of complementary techniques on the pain felt.	3 months	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.

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France