Back to resultsPain and Stress Assessment in Children
Primary Purpose
Acute Respiratory Infections
Status
Completed
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Vibrocompression and aspiration of secretions
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Infections focused on measuring Pain, Stress, Physiotherapy, Children
Eligibility Criteria
Inclusion Criteria:
- Indication of Respiratory Therapy
Fasting for one hour before the moment of collection
Term of Free and Informed Consent Form (ICF) signed by parents or legal guardians
Exclusion Criteria:
- Children in postoperative period acute
Presence of thoracic drain or mediastinal
Children using drugs to sedative or analgesic purpose of deep sedation
Sites / Locations
- FUUberlândia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Aspiration of secretion
Vibrocompression
Arm Description
10 children are evaluated at rest, during and after aspiration technique secretion
10 children will be assessed at rest, during and after the maneuver vibrocompression
Outcomes
Primary Outcome Measures
Assess whether there is pain in children when performed randomized technique
Rate NIPS - Infant Pain Scale
Secondary Outcome Measures
Assess whether there is stress in children during the technical run
Biochemical analysis of cortisol and salivary amylase
Full Information
NCT ID
NCT01731834
First Posted
November 18, 2012
Last Updated
November 27, 2013
Sponsor
Federal University of Uberlandia
1. Study Identification
Unique Protocol Identification Number
NCT01731834
Brief Title
Pain and Stress Assessment in Children
Official Title
Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions.
Detailed Description
Randomization to 10 children and 10 vibrocompression for aspiration of secretion.
Fill in the evaluation form. Monitoring Heart Rate and Peripheral O2 Saturation (rest, during and after the technique performed).
Photographic Record (rest, during and after the technique performed). Saliva Collection (rest, 5, 20 and 40 minutes after running technics). Data analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infections
Keywords
Pain, Stress, Physiotherapy, Children
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspiration of secretion
Arm Type
Active Comparator
Arm Description
10 children are evaluated at rest, during and after aspiration technique secretion
Arm Title
Vibrocompression
Arm Type
Experimental
Arm Description
10 children will be assessed at rest, during and after the maneuver vibrocompression
Intervention Type
Other
Intervention Name(s)
Vibrocompression and aspiration of secretions
Intervention Description
The 20 children, study participants will be randomly assigned to different groups, where 10 children will be evaluated during vibrocompression maneuver, and another 10 will be assessed on the aspiration procedure. Randomization will be performed using an opaque envelope for specifying which group selection technique is evaluated.
Primary Outcome Measure Information:
Title
Assess whether there is pain in children when performed randomized technique
Description
Rate NIPS - Infant Pain Scale
Time Frame
two years
Secondary Outcome Measure Information:
Title
Assess whether there is stress in children during the technical run
Description
Biochemical analysis of cortisol and salivary amylase
Time Frame
two years
Other Pre-specified Outcome Measures:
Title
Correlate the pain and the stress generated.
Description
Also assess heart rate, respiratory rate, and oxygen saturation.
Time Frame
two yars
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indication of Respiratory Therapy
Fasting for one hour before the moment of collection
Term of Free and Informed Consent Form (ICF) signed by parents or legal guardians
Exclusion Criteria:
Children in postoperative period acute
Presence of thoracic drain or mediastinal
Children using drugs to sedative or analgesic purpose of deep sedation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Biasi, Third
Organizational Affiliation
FUUberlândia
Official's Role
Principal Investigator
Facility Information:
Facility Name
FUUberlândia
City
Uberlândia
State/Province
Minas Gerais
Country
Brazil
12. IPD Sharing Statement
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Pain and Stress Assessment in Children
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