Assessment of Pain and Stress in Children
This study is currently recruiting participants.
Verified November 2012 by Federal University of Uberlandia
Sponsor:
Federal University of Uberlandia
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 21, 2012
Last verified: November 2012
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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: | Assessment of Pain and Stress in Children Undergoing Respiratory Physiotherapy |
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.
| Estimated Enrollment: | 17 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731834
Contacts
| Contact: Maria Biasi, third | 34 3219-1235 ext 34 9991-3087 | mariateresabiasi@bol.com.br |
| Contact: Maria Biasi, third | 34 3219-1235 | mariateresabiasi@bol.com.br |
Locations
| Brazil | |
| FUUberlândia | Recruiting |
| Uberlândia, Minas Gerais, Brazil | |
| Contact: Maria Biasi, Third 34 3219-1235 mariateresabiasi@bol.com.br | |
| Contact: Maria Biasi, Third 34 9991-3087 mariateresabiasi@bol.com.br | |
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 21, 2012 |
| 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 May 16, 2013