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Lung TransplantTOOLBOXNCT03167528

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

A study testing Relaxation, Hypnosis and Holistic gymnastics in people with Lung Transplant, run by Hopital Foch at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Transplant
What is being tested?
Relaxation, Hypnosis and Holistic gymnastics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFrance
Study dates
3 May 2017to 3 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Foch

    Suresnes, 92150

Other trials in France

About this study

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

Read the 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.

Conditions
Lung Transplant
Being tested
Relaxation, Hypnosis, Holistic gymnastics, Transcutaneous electrical nerve stimulation (TENS), Sophrology
Keywords
Pain, Quality of life
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelaxationBehavioural

    Relaxation

  • HypnosisBehavioural

    Hypnosis

  • Holistic gymnasticsBehavioural

    holistic gymnastics

  • Transcutaneous electrical nerve stimulation (TENS)Device

    TENS

  • SophrologyBehavioural

    Sophrology

Study groups in NCT03167528
Study groupRoleWhat they receive
Lung transplantExperimentalPatients 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.
Receives: Behavioral: Relaxation; Behavioral: Hypnosis; Behavioral: Holistic gymnastics; Device: Transcutaneous electrical nerve stimulation (TENS); Behavioral: Sophrology

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (6)

  1. 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)

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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).

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. 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'.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start3 May 2017
  3. Primary completion3 Sep 2020
  4. Study completion3 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03167528
Sponsor's protocol ID
2016/59
Other IDs
2016-A01654-47
Acronym
TOOLBOX
Status last verified
Nov 2020
First submitted
24 May 2017
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23370071

  • 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.

    PubMed 17888574

  • 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.

    PubMed 4037594

  • 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.

    PubMed 22528542

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

  • 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.

    PubMed 25150816

  • 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.

    PubMed 20173435

  • 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.

    PubMed 17099034

  • 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.

    PubMed 20882729

  • 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.

    PubMed 24941199

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

  • 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.

    PubMed 25324802

  • 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.

    PubMed 25796509

  • 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.

    PubMed 11109057

  • 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.

    PubMed 19596518

Questions about this trial

What is this clinical trial studying?

A study testing Relaxation, Hypnosis and Holistic gymnastics in people with Lung Transplant, run by Hopital Foch at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of sessions of complementary techniques (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03167528, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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