The Painful Real-life Experience of the Child of Less Than Three Years During the Removal of the Collecting Bags in the Pediatric Urgency: What Strategy of Coverage? (LINIPOCHE)
Primary Purpose
Urinary Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oiled-limestone liniment
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Infection
Eligibility Criteria
Inclusion Criteria:
- The children of zero in 36 months
- Children whose legal representatives accept the participation in the study
- the children must be affiliated or benefit from a health insurance scheme
Exclusion Criteria:
- Child of more than three years old
- Premature Child
- History of collection bag
- Irritated Siege
- Diarrhea
Sites / Locations
- Limoges university hospital center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oiled-limestone liniment
without Oiled-limestone liniment
Arm Description
the removal of the collecting bag is made with the Oiled-limestone liniment.
the removal of the collecting bag is made without any special precautions
Outcomes
Primary Outcome Measures
The level of pain measured by the FLACC scale
Secondary Outcome Measures
Comparison at the girls and the boys of the score of the FLACC scale
Full Information
NCT ID
NCT01659190
First Posted
August 3, 2012
Last Updated
January 10, 2014
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT01659190
Brief Title
The Painful Real-life Experience of the Child of Less Than Three Years During the Removal of the Collecting Bags in the Pediatric Urgency: What Strategy of Coverage?
Acronym
LINIPOCHE
Official Title
The Painful Real-life Experience of the Child of Less Than Three Years During the Removal of the Collecting Bags in the Pediatric Urgency: What Strategy of Coverage?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags.
Work teams have set as their main goal to compare the different levels of acute pain involved for children under 3 during the removing of the collecting bag, depending on the use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main endpoint, the difference between the results assigned to the acute pain by a pain evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).
Detailed Description
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags. This nursing care, extensively recommended for young children, was the subject of a study (still in progress) in 2009 conducted by the nurses of the CHU of Limoges and the CHI of Poissy. The results have shown that the removal of the collecting bags could involve pains as severe, or even worse, as the ones observed during a urinary catheter.
The lack of documentation and stunning results of our 2009 study persuaded healthcare teams to carry on their researches and posed the following problem: the removal of the collecting bags can cause an acute pain which could result in a major discomfort for a child under 3.
In practice, the removal of the collecting bag is made without any special precautions, or with the use of several products such as the Oiled-limestone liniment. This non-medicated product, commonly used for the care of the infant seat, intra and extra hospital field, would facilitate the removal of adhesives and plasters, according to the empirical experience of caregivers. Work teams have set as their main goal to compare the different levels of acute pain involved for children under 3 during the removing of the collecting bag, depending on the use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main endpoint, the difference between the results assigned to the acute pain by a pain evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).
Thanks to studies in usual care among different medical centers, that would be randomized and blindly conducted, healthcare teams would like to verify the hypothesis that the use of Oiled-limestone liniment could reduce acute pain involved in the removal of urine collecting bags among children under 36 months old. The study will be submitted to the parents of children aged 0 to 36 months old admitted to the pediatric emergency and needing a urine sample using a collecting bag.
The method of pain evaluation with the FLACC scale will be carried out as following: a caregiver will remove the collecting bag, with or without the use of the Oiled-limestone liniment, according to a prior randomized draw, and, at the same time, a second caregiver will film the care in order to provide experts assigned to measure objectively the level of the pain felt by the child during the care with videos.
Based on 136 children, during 24 months, this study would imply 3 inclusions in every medical center each month. Each inclusion should last 30 minutes.
Expected benefits would be, at first, improvement in the quality of healthcare for young children and improvement in the practice of the nurses, the nursery nurses, the auxiliaries of child welfare and the caregivers. This study would also suggests new recommendations for a good practice of nursing care, with accurate guidelines helping with the removal of collecting bags among children under 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oiled-limestone liniment
Arm Type
Experimental
Arm Description
the removal of the collecting bag is made with the Oiled-limestone liniment.
Arm Title
without Oiled-limestone liniment
Arm Type
No Intervention
Arm Description
the removal of the collecting bag is made without any special precautions
Intervention Type
Other
Intervention Name(s)
Oiled-limestone liniment
Primary Outcome Measure Information:
Title
The level of pain measured by the FLACC scale
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Comparison at the girls and the boys of the score of the FLACC scale
Time Frame
5 minutes
10. Eligibility
Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The children of zero in 36 months
Children whose legal representatives accept the participation in the study
the children must be affiliated or benefit from a health insurance scheme
Exclusion Criteria:
Child of more than three years old
Premature Child
History of collection bag
Irritated Siege
Diarrhea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles LAMY
Organizational Affiliation
University Hospital, Limoges
Official's Role
Study Director
Facility Information:
Facility Name
Limoges university hospital center
City
Limoges
ZIP/Postal Code
87 042
Country
France
12. IPD Sharing Statement
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The Painful Real-life Experience of the Child of Less Than Three Years During the Removal of the Collecting Bags in the Pediatric Urgency: What Strategy of Coverage?
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