Acute Respiratory InfectionsEarly Phase 1NCT01731834
Pain and Stress Assessment in Children
A Early Phase 1 study testing Vibrocompression and aspiration of secretions in people with Acute Respiratory Infections, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Acute Respiratory Infections
- What is being tested?
- Vibrocompression and aspiration of secretions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Nov 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children in postoperative period acute
- Presence of thoracic drain or mediastinal
- Children using drugs to sedative or analgesic purpose of deep sedation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques
There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions.
Read the 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.
- Conditions
- Acute Respiratory Infections
- Being tested
- Vibrocompression and aspiration of secretions
- Keywords
- Pain, Stress, Physiotherapy, Children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrocompression and aspiration of secretionsOther
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 group | Role | What they receive |
|---|---|---|
| Aspiration of secretion | Active comparator | 10 children are evaluated at rest, during and after aspiration technique secretion Receives: Other: Vibrocompression and aspiration of secretions |
| Vibrocompression | Experimental | 10 children will be assessed at rest, during and after the maneuver vibrocompression Receives: Other: Vibrocompression and aspiration of secretions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether there is pain in children when performed randomized technique
Rate NIPS - Infant Pain Scale
Measured: two years
Secondary outcomes (1)
Assess whether there is stress in children during the technical run
Biochemical analysis of cortisol and salivary amylase
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Teresa de Mendonça Biasi, Federal University of Uberlandia
- Investigators
- Maria Biasi, Third, Principal investigator, FUUberlândia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731834
- Sponsor's protocol ID
- 11212PSC014
- Other IDs
- FUUberlandia
- Status last verified
- Nov 2013
- First submitted
- 18 Nov 2012
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques
- ClinicalTrials.gov ID
- NCT01731834
- Acronym / sponsor ID
- 11212PSC014
- Conditions
- Acute Respiratory Infections
- Keywords
- Pain, Stress, Physiotherapy, Children
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspiration of secretion | Active comparator | Other: Vibrocompression and aspiration of secretions10 children are evaluated at rest, during and after aspiration technique secretion |
| Vibrocompression | Experimental | Other: Vibrocompression and aspiration of secretions10 children will be assessed at rest, during and after the maneuver vibrocompression |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Children in postoperative period acute
- Presence of thoracic drain or mediastinal
- Children using drugs to sedative or analgesic purpose of deep sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrocompression and aspiration of secretionsThe 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. | Other | Aspiration of secretion, Vibrocompression |
Primary outcome
Assess whether there is pain in children when performed randomized technique
Time frame: two years
Rate NIPS - Infant Pain Scale
1 secondary outcome
Assess whether there is stress in children during the technical run
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
Related trials for Acute Respiratory Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Biasi, Third principal investigator
FUUberlândia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vibrocompression and aspiration of secretions in people with Acute Respiratory Infections, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether there is pain in children when performed randomized technique (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2013.