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

November 3, 2020 updated by: Hopital Foch
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hopital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lung transplant

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months
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 months
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).
3 months
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.
3 months
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.
3 months
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'.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 3, 2017

Primary Completion (ACTUAL)

September 3, 2020

Study Completion (ACTUAL)

September 3, 2020

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (ACTUAL)

May 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016/59
  • 2016-A01654-47 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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