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Completed

NCT Number: NCT03167528

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

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

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Key information

Conditions

Lung Transplant Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation

Behavioral

Relaxation

hypnosis

Behavioral

Hypnosis

Holistic gymnastics

Behavioral

holistic gymnastics

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

TENS

Sophrology

Behavioral

Sophrology

Primary outcomes

  1. Number of sessions of complementary techniques

    Time frame: 3 months

    Number of sessions of complementary techniques practiced by the patient alone and by the patient with an investigator of the team.

Secondary outcomes

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

    Time frame: 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)

  2. Efficacy of complementary techniques on the pain felt.

    Time frame: 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.

  3. Efficacy of complementary techniques on anxiety and depression level

    Time frame: 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).

  4. Efficacy of complementary techniques on stress level

    Time frame: 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.

  5. Efficacy of complementary techniques on sleep quality

    Time frame: 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.

  6. Efficacy of complementary techniques on quality of life

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: TOOLBOX

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 30, 2017
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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