Pain and Stress Assessment in Children

Study Overview
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Brief Summary
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There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions.

Detailed Description
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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.

Official Title
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Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques

Conditions
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Acute Respiratory Infections

Intervention / Treatment
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* Other: Vibrocompression and aspiration of secretions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess whether there is pain in children when performed randomized technique | 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 | Biochemical analysis of cortisol and salivary amylase | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Stress, Physiotherapy, Children