Pain and Stress Assessment in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Teresa de Mendonça Biasi, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT01731834
First received: November 18, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Acute Respiratory Infections
Other: Vibrocompression and aspiration of secretions
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques

Further study details as provided by Federal University of Uberlandia:

Primary Outcome Measures:
  • Assess whether there is pain in children when performed randomized technique [ Time Frame: two years ] [ Designated as safety issue: No ]
    Rate NIPS - Infant Pain Scale


Secondary Outcome Measures:
  • Assess whether there is stress in children during the technical run [ Time Frame: two years ] [ Designated as safety issue: No ]
    Biochemical analysis of cortisol and salivary amylase


Other Outcome Measures:
  • Correlate the pain and the stress generated. [ Time Frame: two yars ] [ Designated as safety issue: No ]
    Also assess heart rate, respiratory rate, and oxygen saturation.


Enrollment: 20
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731834

Locations
Brazil
FUUberlândia
Uberlândia, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Principal Investigator: Maria Biasi, Third FUUberlândia
  More Information

No publications 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     History of Changes
Other Study ID Numbers: 11212PSC014, FUUberlandia
Study First Received: November 18, 2012
Last Updated: November 27, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Uberlandia:
Pain
Stress
Physiotherapy
Children

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014