Pain and Stress Assessment in Children

Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01731834

Enrollment

Registered

2012-11-22

Start date

2011-09-30

Completion date

2013-11-30

Last updated

2013-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infections

Keywords

Pain, Stress, Physiotherapy, Children

Brief summary

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

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.

Interventions

OTHERVibrocompression 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Assess whether there is pain in children when performed randomized technique	two years	Rate NIPS - Infant Pain Scale

Secondary

Measure	Time frame	Description
Assess whether there is stress in children during the technical run	two years	Biochemical analysis of cortisol and salivary amylase

Other

Measure	Time frame	Description
Correlate the pain and the stress generated.	two yars	Also assess heart rate, respiratory rate, and oxygen saturation.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026