Pain and Stress Assessment in Children

Early Phase 1

Completed

• Conditions: Acute Respiratory Infections

• Registration Number: NCT01731834
• Lead Sponsor: Federal University of Uberlandia

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-11-18
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-22
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assess whether there is pain in children when performed randomized technique	two years	Rate NIPS - Infant Pain Scale

Secondary Outcome Measures

Name	Time	Method
Assess whether there is stress in children during the technical run	two years	Biochemical analysis of cortisol and salivary amylase

Trial Locations

Locations (1)

FUUberlândia; 🇧🇷 Uberlândia, Minas Gerais, Brazil