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

Lung Transplant Clinical Trial

— TOOLBOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167528
• Other study ID #: 2016/59
• Secondary ID: 2016-A01654-47
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: September 3, 2020

Study information

• Verified date: November 2020
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 3, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant

Intervention

Behavioral:
• Relaxation
Relaxation
• Hypnosis
Hypnosis
• Holistic gymnastics
holistic gymnastics

Device:
• Transcutaneous electrical nerve stimulation (TENS)
TENS

Behavioral:
• Sophrology
Sophrology

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (19)

13. Servant D. La relaxation, nouvelles approches nouvelles pratiques: Elsevier-Masson; 2009.

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

Anbar RD. Self-hypnosis for patients with cystic fibrosis. Pediatr Pulmonol. 2000 Dec;30(6):461-5. — View 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. — View Citation

Bouhassira D, Lantéri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-7. Epub 2007 Sep 20. — View Citation

Carroll D, Moore RA, McQuay HJ, Fairman F, Tramèr M, Leijon G. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2001;(3):CD003222. Review. Update in: Cochrane Database Syst Rev. 2008;(3):CD003222. — View 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. — View 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;(6):CD003148. doi: 10.1002/14651858.CD003148.pub3. Review. — View 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. — View Citation

Jensen MP. Hypnosis for chronic pain management: a new hope. Pain. 2009 Dec;146(3):235-7. doi: 10.1016/j.pain.2009.06.027. Epub 2009 Jul 10. — View Citation

Lépine JP, Godchau M, Brun P, Lempérière T. [Evaluation of anxiety and depression among patients hospitalized on an internal medicine service]. Ann Med Psychol (Paris). 1985 Feb;143(2):175-89. French. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Spiegel R. Sleep and sleeplessness in advanced age. Advances in Sleep Research. Lancaster UK: MTP Press; 1981. p. 1-272.

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. — View 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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