Pain and Stress Assessment in Children

November 27, 2013 updated by: Maria Teresa de Mendonça Biasi, Federal University of Uberlandia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Uberlândia, Minas Gerais, Brazil
        • FUUberlândia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aspiration of secretion
10 children are evaluated at rest, during and after aspiration technique secretion
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.
Experimental: Vibrocompression
10 children will be assessed at rest, during and after the maneuver vibrocompression
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess whether there is pain in children when performed randomized technique
Time Frame: two years
Rate NIPS - Infant Pain Scale
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess whether there is stress in children during the technical run
Time Frame: two years
Biochemical analysis of cortisol and salivary amylase
two years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the pain and the stress generated.
Time Frame: two yars
Also assess heart rate, respiratory rate, and oxygen saturation.
two yars

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Investigators

  • Principal Investigator: Maria Biasi, Third, FUUberlândia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 18, 2012

First Submitted That Met QC Criteria

November 21, 2012

First Posted (Estimate)

November 22, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11212PSC014
  • FUUberlandia (Registry Identifier: FUUberlandia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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