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Pain and Stress Assessment in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01731834
First Posted: November 22, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Teresa de Mendonça Biasi, Federal University of Uberlandia
  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 Early Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Maria Teresa de Mendonça Biasi, Federal University of Uberlandia:

Primary Outcome Measures:
  • Assess whether there is pain in children when performed randomized technique [ Time Frame: two years ]
    Rate NIPS - Infant Pain Scale


Secondary Outcome Measures:
  • Assess whether there is stress in children during the technical run [ Time Frame: two years ]
    Biochemical analysis of cortisol and salivary amylase


Other Outcome Measures:
  • Correlate the pain and the stress generated. [ Time Frame: two yars ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731834


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

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 ( Registry Identifier: FUUberlandia )
First Submitted: November 18, 2012
First Posted: November 22, 2012
Last Update Posted: October 12, 2017
Last Verified: November 2013

Keywords provided by Maria Teresa de Mendonça Biasi, Federal University of Uberlandia:
Pain
Stress
Physiotherapy
Children

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