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Completed

NCT Number: NCT01731834

Pain and Stress Assessment in Children

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

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Key information

Conditions

Acute Respiratory Infections Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

FUUberlândia

Uberlândia, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrocompression and aspiration of secretions

Other

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 outcomes

  1. Assess whether there is pain in children when performed randomized technique

    Time frame: two years

    Rate NIPS - Infant Pain Scale

Secondary outcomes

  1. Assess whether there is stress in children during the technical run

    Time frame: two years

    Biochemical analysis of cortisol and salivary amylase

Other outcomes

  1. Correlate the pain and the stress generated.

    Time frame: two yars

    Also assess heart rate, respiratory rate, and oxygen saturation.

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2012
Registry last updated
Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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