Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-05 @ 11:02 AM
Study NCT ID:
NCT03167528
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of sessions of complementary techniques', 'timeFrame': '3 months', 'description': 'Number of sessions of complementary techniques practiced by the patient alone and by the patient with an investigator of the team.'}], 'secondaryOutcomes': [{'measure': 'Implication and satisfaction degree measured by Visual Analogical Scale (VAS)', 'timeFrame': '3 months', 'description': '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)'}, {'measure': 'Efficacy of complementary techniques on the pain felt.', 'timeFrame': '3 months', 'description': '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.\n\n3 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.\n\nDN4 to identify neuropatic pain: 4 questions to answer by "yes" or "no". "yes" = 1 point, "no" = 0 point. Total score ≥ 4/10 = positive test.\n\nKehlet\'s questionnaire to evaluate the impact of pain on activities.'}, {'measure': 'Efficacy of complementary techniques on anxiety and depression level', 'timeFrame': '3 months', 'description': '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).'}, {'measure': 'Efficacy of complementary techniques on stress level', 'timeFrame': '3 months', 'description': 'Evaluate the efficacy of the "toolbox" on stress level 3 months after transplant by Perceived Stress Scale. 10 items rated from 0 to 5.\n\nTotal 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.\n\nTotal score \\> 27 = someone who don\'t knows how to manage stress.'}, {'measure': 'Efficacy of complementary techniques on sleep quality', 'timeFrame': '3 months', 'description': 'Evaluate the efficacy of the "toolbox" on sleep quality 3 months after transplant by Spiegel sleep score. 6 items rated from 0 to 5.\n\nMore the score is lower, more the sleep disorders is serious.'}, {'measure': 'Efficacy of complementary techniques on quality of life', 'timeFrame': '3 months', 'description': '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) .\n\nEQ5D: 5 dimensions. Each dimension has 3 levels: no problems, some problems, extreme problems.\n\nEQ 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\'.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'Quality of life'], 'conditions': ['Lung Transplant']}, 'referencesModule': {'references': [{'pmid': '23370071', 'type': 'BACKGROUND', 'citation': 'Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.'}, {'pmid': '17888574', 'type': 'BACKGROUND', 'citation': 'Bouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.'}, {'pmid': '4037594', 'type': 'BACKGROUND', 'citation': 'Lepine JP, Godchau M, Brun P, Lemperiere T. [Evaluation of anxiety and depression among patients hospitalized on an internal medicine service]. Ann Med Psychol (Paris). 1985 Feb;143(2):175-89. No abstract available. French.'}, {'pmid': '22528542', 'type': 'BACKGROUND', 'citation': 'Lesage FX, Berjot S, Deschamps F. Psychometric properties of the French versions of the Perceived Stress Scale. Int J Occup Med Environ Health. 2012 Jun;25(2):178-84. doi: 10.2478/S13382-012-0024-8. Epub 2012 Apr 19.'}, {'type': 'BACKGROUND', 'citation': 'Spiegel R. Sleep and sleeplessness in advanced age. Advances in Sleep Research. Lancaster UK: MTP Press; 1981. p. 1-272.'}, {'pmid': '25150816', 'type': 'BACKGROUND', 'citation': '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': '20173435', 'type': 'BACKGROUND', 'citation': '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': '17099034', 'type': 'BACKGROUND', 'citation': 'Girard F, Chouinard P, Boudreault D, Poirier C, Richard C, Ruel M, Ferraro P. Prevalence and impact of pain on the quality of life of lung transplant recipients: a prospective observational study. Chest. 2006 Nov;130(5):1535-40. doi: 10.1378/chest.130.5.1535.'}, {'pmid': '20882729', 'type': 'BACKGROUND', 'citation': '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': '24941199', 'type': 'BACKGROUND', 'citation': 'Goldbeck L, Fidika A, Herle M, Quittner AL. Psychological interventions for individuals with cystic fibrosis and their families. Cochrane Database Syst Rev. 2014 Jun 18;2014(6):CD003148. doi: 10.1002/14651858.CD003148.pub3.'}, {'type': 'BACKGROUND', 'citation': '13. Servant D. La relaxation, nouvelles approches nouvelles pratiques: Elsevier-Masson; 2009.'}, {'pmid': '25324802', 'type': 'BACKGROUND', 'citation': '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': '25796509', 'type': 'BACKGROUND', 'citation': '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': '11109057', 'type': 'BACKGROUND', 'citation': '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': '19596518', 'type': 'BACKGROUND', 'citation': 'Jensen MP. Hypnosis for chronic pain management: a new hope. Pain. 2009 Dec;146(3):235-237. doi: 10.1016/j.pain.2009.06.027. Epub 2009 Jul 10. No abstract available.'}, {'pmid': '23628907', 'type': 'BACKGROUND', 'citation': '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': '11687055', 'type': 'BACKGROUND', 'citation': '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': '12600800', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '21. Michel-Cherqui M. Effect of TENS (TransCutaneous Electrical NeuroStimulation) on post lung transplantation pain. 11th International Congress on Lung Transplantation Paris; 2014.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThe 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.\n\nThe overall benefit will be judged comparing period before transplant to period after transplant on different criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidates for a lung transplantation benefiting from a pre-transplant evaluation\n\nExclusion Criteria:\n\n* transplant patient in emergency\n* delay between pre-transplant evaluation and transplantation over 12 months'}, 'identificationModule': {'nctId': 'NCT03167528', 'acronym': 'TOOLBOX', 'briefTitle': 'Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients', 'orgStudyIdInfo': {'id': '2016/59'}, 'secondaryIdInfos': [{'id': '2016-A01654-47', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lung transplant', 'description': 'Patients who must undergo a lung transplant at the FOCH hospital.\n\nBefore and after transplantation, patients benefits of learning and realization sessions of complementary techniques:\n\n* Relaxation,\n* Hypnosis,\n* Holistic gymnastics,\n* Transcutaneous electrical nerve stimulation (TENS),\n* Sophrology.', 'interventionNames': ['Behavioral: Relaxation', 'Behavioral: Hypnosis', 'Behavioral: Holistic gymnastics', 'Device: Transcutaneous electrical nerve stimulation (TENS)', 'Behavioral: Sophrology']}], 'interventions': [{'name': 'Relaxation', 'type': 'BEHAVIORAL', 'description': 'Relaxation', 'armGroupLabels': ['Lung transplant']}, {'name': 'Hypnosis', 'type': 'BEHAVIORAL', 'description': 'Hypnosis', 'armGroupLabels': ['Lung transplant']}, {'name': 'Holistic gymnastics', 'type': 'BEHAVIORAL', 'description': 'holistic gymnastics', 'armGroupLabels': ['Lung transplant']}, {'name': 'Transcutaneous electrical nerve stimulation (TENS)', 'type': 'DEVICE', 'description': 'TENS', 'armGroupLabels': ['Lung transplant']}, {'name': 'Sophrology', 'type': 'BEHAVIORAL', 'description': 'Sophrology', 'armGroupLabels': ['Lung transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Mireille MICHEL-CHERQUI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FOCH Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}