Pain and Stress Assessment in Children

Sponsor

Federal University of Uberlandia (Other)

Overall Status

Completed

CT.gov ID

NCT01731834

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Infections	Other: Vibrocompression and aspiration of secretions	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Assess whether there is pain in children when performed randomized technique [two years]
Rate NIPS - Infant Pain Scale

Secondary Outcome Measures

Assess whether there is stress in children during the technical run [two years]
Biochemical analysis of cortisol and salivary amylase

Other Outcome Measures

Correlate the pain and the stress generated. [two yars]
Also assess heart rate, respiratory rate, and oxygen saturation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FUUberlândia	Uberlândia	Minas Gerais	Brazil

Sponsors and Collaborators

Federal University of Uberlandia

Investigators

Principal Investigator: Maria Biasi, Third, FUUberlândia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Teresa de Mendonça Biasi, Assessment of pain and stress in children undergoing respiratory physiotherapy, Federal University of Uberlandia

ClinicalTrials.gov Identifier:

NCT01731834

Other Study ID Numbers:

11212PSC014
FUUberlandia

First Posted:

Nov 22, 2012

Last Update Posted:

Dec 2, 2013

Last Verified:

Nov 1, 2013

Keywords provided by Maria Teresa de Mendonça Biasi, Assessment of pain and stress in children undergoing respiratory physiotherapy, Federal University of Uberlandia

Additional relevant MeSH terms:

Respiratory Tract Infections

Study Results

No Results Posted as of Dec 2, 2013