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

NCT03167528 | Completed

• 2 other identifiers: 2016/592016-A01654-47
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Transplant

Keywords

Pain; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Implication and satisfaction degree measured by Visual Analogical Scale (VAS)

  3 months

• Efficacy of complementary techniques on the pain felt.

  3 months

• Efficacy of complementary techniques on anxiety and depression level

  3 months

• Efficacy of complementary techniques on stress level

  3 months

• Efficacy of complementary techniques on sleep quality

  3 months

Study Arms (1)

Lung transplant

EXPERIMENTAL

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; Behavioral: Hypnosis; Behavioral: Holistic gymnastics; Device: Transcutaneous electrical nerve stimulation (TENS); Behavioral: Sophrology

Interventions

Relaxation BEHAVIORAL

Relaxation

Lung transplant

Hypnosis BEHAVIORAL

Hypnosis

Lung transplant

Holistic gymnastics BEHAVIORAL

holistic gymnastics

Lung transplant

Transcutaneous electrical nerve stimulation (TENS) DEVICE

TENS

Lung transplant

Sophrology BEHAVIORAL

Sophrology

Lung transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (19)

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  PMID: 17888574 BACKGROUND

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  PMID: 4037594 BACKGROUND

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  PMID: 22528542 BACKGROUND

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  BACKGROUND

• Michel-Cherqui M, Ley L, Szekely B, Dreyfus JF, Fischler M. Prevalence and characteristics of pain in patients awaiting lung transplantation. J Pain Symptom Manage. 2015 Mar;49(3):548-54. doi: 10.1016/j.jpainsymman.2014.07.011. Epub 2014 Aug 21.

  PMID: 25150816 BACKGROUND

• Wildgaard K, Iversen M, Kehlet H. Chronic pain after lung transplantation: a nationwide study. Clin J Pain. 2010 Mar-Apr;26(3):217-22. doi: 10.1097/AJP.0b013e3181b705e4.

  PMID: 20173435 BACKGROUND

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  PMID: 17099034 BACKGROUND

• Gross CR, Kreitzer MJ, Thomas W, Reilly-Spong M, Cramer-Bornemann M, Nyman JA, Frazier P, Ibrahim HN. Mindfulness-based stress reduction for solid organ transplant recipients: a randomized controlled trial. Altern Ther Health Med. 2010 Sep-Oct;16(5):30-8.

  PMID: 20882729 BACKGROUND

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  PMID: 24941199 BACKGROUND

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  BACKGROUND

• McCraty R, Zayas MA. Cardiac coherence, self-regulation, autonomic stability, and psychosocial well-being. Front Psychol. 2014 Sep 29;5:1090. doi: 10.3389/fpsyg.2014.01090. eCollection 2014.

  PMID: 25324802 BACKGROUND

• Sarabia-Cobo CM. Heart coherence: a new tool in the management of stress on professionals and family caregivers of patients with dementia. Appl Psychophysiol Biofeedback. 2015 Jun;40(2):75-83. doi: 10.1007/s10484-015-9276-y.

  PMID: 25796509 BACKGROUND

• Anbar RD. Self-hypnosis for patients with cystic fibrosis. Pediatr Pulmonol. 2000 Dec;30(6):461-5. doi: 10.1002/1099-0496(200012)30:63.0.co;2-4.

  PMID: 11109057 BACKGROUND

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  PMID: 19596518 BACKGROUND

• Tefikow S, Barth J, Maichrowitz S, Beelmann A, Strauss B, Rosendahl J. Efficacy of hypnosis in adults undergoing surgery or medical procedures: a meta-analysis of randomized controlled trials. Clin Psychol Rev. 2013 Jul;33(5):623-36. doi: 10.1016/j.cpr.2013.03.005. Epub 2013 Mar 26.

  PMID: 23628907 BACKGROUND

• Carroll D, Moore RA, McQuay HJ, Fairman F, Tramer M, Leijon G. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2001;(3):CD003222. doi: 10.1002/14651858.CD003222.

  PMID: 11687055 BACKGROUND

• Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.

  PMID: 12600800 BACKGROUND

• 21. Michel-Cherqui M. Effect of TENS (TransCutaneous Electrical NeuroStimulation) on post lung transplantation pain. 11th International Congress on Lung Transplantation Paris; 2014.

  BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Hypnosis; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Mireille MICHEL-CHERQUI, MD

  FOCH Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: May 3, 2017
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)