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Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Taken Care (MUCODOULEUR)

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lung transplant
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients benefiting from a lung transplant
  • Patients on a list for a lung transplant from may 2010

Exclusion Criteria:

  • Patients refusing to participate in the study

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung transplant

Arm Description

Pain evaluation

Outcomes

Primary Outcome Measures

Chronic pain measured by a digital scale

Secondary Outcome Measures

Full Information

First Posted
August 31, 2016
Last Updated
May 19, 2017
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02897882
Brief Title
Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Taken Care
Acronym
MUCODOULEUR
Official Title
Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Medical Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
April 27, 2017 (Actual)
Study Completion Date
April 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. It is a forward-looking study of prevalence entering within the framework of the common care. After lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung transplant
Arm Type
Experimental
Arm Description
Pain evaluation
Intervention Type
Other
Intervention Name(s)
Lung transplant
Intervention Description
Pain evaluation
Primary Outcome Measure Information:
Title
Chronic pain measured by a digital scale
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients benefiting from a lung transplant Patients on a list for a lung transplant from may 2010 Exclusion Criteria: Patients refusing to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Fischler, PhD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acute and Chronic Pain in Lung Transplantation: Prevalence, Associated Factors, Taken Care

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