Pain and Stress Assessment in Children

Acute Respiratory Infections Clinical Trial

Official title:

Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731834
• Other study ID #: 11212PSC014
• Secondary ID: FUUberlandia
• Status: Completed
• Phase: Early Phase 1
• First received: November 18, 2012
• Last updated: November 27, 2013
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infections
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Brazil	FUUberlândia	Uberlândia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlate the pain and the stress generated.	Also assess heart rate, respiratory rate, and oxygen saturation.	two yars
Primary	Assess whether there is pain in children when performed randomized technique	Rate NIPS - Infant Pain Scale	two years
Secondary	Assess whether there is stress in children during the technical run	Biochemical analysis of cortisol and salivary amylase	two years