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
About this trial
This is an interventional other trial for Pain
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
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
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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