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Pain and Stress Assessment in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Teresa de Mendonça Biasi, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT01731834
First received: November 18, 2012
Last updated: November 27, 2013
Last verified: November 2013

November 18, 2012
November 27, 2013
September 2011
November 2013   (final data collection date for primary outcome measure)
Assess whether there is pain in children when performed randomized technique [ Time Frame: two years ] [ Designated as safety issue: No ]
Rate NIPS - Infant Pain Scale
Same as current
Complete list of historical versions of study NCT01731834 on ClinicalTrials.gov Archive Site
Assess whether there is stress in children during the technical run [ Time Frame: two years ] [ Designated as safety issue: No ]
Biochemical analysis of cortisol and salivary amylase
Same as current
Correlate the pain and the stress generated. [ Time Frame: two yars ] [ Designated as safety issue: No ]
Also assess heart rate, respiratory rate, and oxygen saturation.
Same as current
 
Pain and Stress Assessment in Children
Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques

There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions.

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.

Interventional
Phase 0
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Acute Respiratory Infections
Other: Vibrocompression and aspiration of secretions
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.
  • Active Comparator: Aspiration of secretion
    10 children are evaluated at rest, during and after aspiration technique secretion
    Intervention: Other: Vibrocompression and aspiration of secretions
  • Experimental: Vibrocompression
    10 children will be assessed at rest, during and after the maneuver vibrocompression
    Intervention: Other: Vibrocompression and aspiration of secretions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2013
November 2013   (final data collection date for primary outcome measure)

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

Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01731834
11212PSC014, FUUberlandia
No
Maria Teresa de Mendonça Biasi, Federal University of Uberlandia
Federal University of Uberlandia
Not Provided
Principal Investigator: Maria Biasi, Third FUUberlândia
Federal University of Uberlandia
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP