Pain and Stress Assessment in Children

NCT ID: NCT01731834

Last Updated: 2013-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-11-30

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.

Conditions

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Acute Respiratory Infections

Keywords

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Pain Stress Physiotherapy Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aspiration of secretion

10 children are evaluated at rest, during and after aspiration technique secretion

Group Type ACTIVE_COMPARATOR

Vibrocompression and aspiration of secretions

Intervention Type 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.

Vibrocompression

10 children will be assessed at rest, during and after the maneuver vibrocompression

Group Type EXPERIMENTAL

Vibrocompression and aspiration of secretions

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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Maria Teresa de Mendonça Biasi

Assessment of pain and stress in children undergoing respiratory physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Biasi, Third

Role: PRINCIPAL_INVESTIGATOR

FUUberlândia

Locations

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FUUberlândia

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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FUUberlandia

Identifier Type: REGISTRY

Identifier Source: secondary_id

11212PSC014

Identifier Type: -

Identifier Source: org_study_id