NCT01731834

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2011

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

November 18, 2012

Last Update Submit

November 27, 2013

Conditions

Acute Respiratory Infections

Keywords

PainStressPhysiotherapyChildren

Outcome Measures

Primary Outcomes (1)

  • Assess whether there is pain in children when performed randomized technique

    Rate NIPS - Infant Pain Scale

    two years

Secondary Outcomes (1)

  • Assess whether there is stress in children during the technical run

    two years

Other Outcomes (1)

  • Correlate the pain and the stress generated.

    two yars

Study Arms (2)

Aspiration of secretion

ACTIVE COMPARATOR

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

Other: Vibrocompression and aspiration of secretions

Vibrocompression

EXPERIMENTAL

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

Other: Vibrocompression and aspiration of secretions

Interventions

Vibrocompression and aspiration of secretionsOTHER

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.

Aspiration of secretionVibrocompression

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children in postoperative period acute
  • Presence of thoracic drain or mediastinal
  • Children using drugs to sedative or analgesic purpose of deep sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FUUberlândia

Uberlândia, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Biasi, Third

    FUUberlândia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of pain and stress in children undergoing respiratory physiotherapy

Study Record Dates

First Submitted

November 18, 2012

First Posted

November 22, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

BR(1)