PediatricNCT05362279
The Effect of Education on Nurses' Knowledge About High-flow Nasal Cannula Oxygen Therapy
A study testing Training in people with Pediatric, run by Izmir Katip Celebi University.
Trial summary
This study was conducted to evaluate the oxygen therapy methods used in pediatric services and to specify the roles and responsibilities of nurses in the application of HFNC, which is one of these methods. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2022to 10 Aug 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nurses working in any of the pediatric emergency departments, pediatric clinics
- No previous training in HFNC treatment
- Follow-up of patients treated with HFNC
- Volunteering to participate in research
Who cannot join
- Those who have received in-service training on HFNC implementation
- Those who work as responsible nurses or training nurses in the clinics where the research will be conducted
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Training on Oxygen Therapy With High Flow Nasal Cannula on the Knowledge Level of Pediatric Nurses; A Randomized Controlled Trial
This study was conducted to evaluate the oxygen therapy methods used in pediatric services and to specify the roles and responsibilities of nurses in the application of HFNC, which is one of these methods. Although the decision to implement this treatment method is under the responsibility of the physician in Turkey, the use of the device, observing the effectiveness of the treatment, monitoring and recording the changes in the vital signs of the children are under the responsibility of the nurses shows the importance of the nursing perspective on HFNC.
Read the detailed description
High-flow nasal cannula oxygen therapy (HFNC) which meets the patient's ventilation need is a non-invasive ventilation system in which warmed and humidified oxygen is administered to the patient at varying flows with the help of a nasal cannula.This study will be conducted as a randomized controlled study with the participation of 70 nurses working in the pediatric clinics of a public hospital between December 2021 and May 2022, as an experimental group (n=35) and a control group (n=35). In the study, two-stage sampling method will be used to determine the nurses who will take place in the experimental and control groups. After the nurses are stratified according to their professional years, assignment to the experimental and control groups will be made by simple random sampling method. The experimental group will be given a pre-test before the training and a post-test one month after the training. In order to avoid interaction between the two groups, the data of the nurses in the control group will be collected first. The knowledge level of the nurses in the experimental and control groups will be evaluated with the HFNC Information Form.
- Conditions
- Pediatric
- Being tested
- Training
- Keywords
- HFNC, Nursing Care, Knowledge Level, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
One month after the pre-test, the post-test will be administered to the nurses who will be in the control group.
Nurses who will be in the experimental group will be given training after the pre-test. A post-test will be administered one month after the training.
| Study group | Role | What they receive |
|---|---|---|
| Test after post-test training | Experimental | Pre-test will be applied to the nurses in the experimental group before the training. The post-test will be applied to the experimental group, to which the pre-test was applied, one month after the training was given. Receives: Other: Training |
| Test without training | No intervention | The nurses in the control group are the group to be administered the post-test without any intervention after the pre-test. The post-test will be administered one month after the pre-test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Level - Education Form- Questionnaire
To increase the knowledge level of nurses about oxygen therapy with high flow nasal cannula.
Measured: One month after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start10 May 2022 (estimated)
- Primary completion10 Jun 2022 (estimated)
- Study completion10 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study with pretest-posttest experimental and control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Alaca, Izmir Katip Celebi University
- Investigators
- Aslı ALACA, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362279
- Sponsor's protocol ID
- AAlaca
- Status last verified
- May 2022
- First submitted
- 23 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colleti Junior J, Longui TE, Carvalho WB. HIGH-FLOW NASAL CANNULA POST-TRACHEAL EXTUBATION IN A CHILD WITH UPPER AIRWAY OBSTRUCTION: CASE REPORT. Rev Paul Pediatr. 2018 Jul-Sep;36(3):372-375. doi: 10.1590/1984-0462/;2018;36;3;00010. Epub 2018 Jul 10.
PubMed 29995143
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training on Oxygen Therapy With High Flow Nasal Cannula on the Knowledge Level of Pediatric Nurses; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05362279
- Acronym / sponsor ID
- AAlaca
- Conditions
- Pediatric
- Keywords
- HFNC, Nursing Care, Knowledge Level, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (estimated)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 10 Aug 2022 (estimated)
- First posted
- 5 May 2022 (actual)
- 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.
This study was conducted to evaluate the oxygen therapy methods used in pediatric services and to specify the roles and responsibilities of nurses in the application of HFNC, which is one of these methods. Although the decision to implement this treatment method is under the responsibility of the physician in Turkey, the use of the device, observing the effectiveness of the treatment, monitoring and recording the changes in the vital signs of the children are under the responsibility of the nurses shows the importance of the nursing perspective on HFNC.
Detailed description
High-flow nasal cannula oxygen therapy (HFNC) which meets the patient's ventilation need is a non-invasive ventilation system in which warmed and humidified oxygen is administered to the patient at varying flows with the help of a nasal cannula.This study will be conducted as a randomized controlled study with the participation of 70 nurses working in the pediatric clinics of a public hospital between December 2021 and May 2022, as an experimental group (n=35) and a control group (n=35). In the study, two-stage sampling method will be used to determine the nurses who will take place in the experimental and control groups. After the nurses are stratified according to their professional years, assignment to the experimental and control groups will be made by simple random sampling method. The experimental group will be given a pre-test before the training and a post-test one month after the training. In order to avoid interaction between the two groups, the data of the nurses in the control group will be collected first. The knowledge level of the nurses in the experimental and control groups will be evaluated with the HFNC Information Form.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled study with pretest-posttest experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| Test after post-test training | Experimental | Other: TrainingPre-test will be applied to the nurses in the experimental group before the training. The post-test will be applied to the experimental group, to which the pre-test was applied, one month after the training was given. |
| Test without training | No intervention | –The nurses in the control group are the group to be administered the post-test without any intervention after the pre-test. The post-test will be administered one month after the pre-test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Nurses working in any of the pediatric emergency departments, pediatric clinics
- No previous training in HFNC treatment
- Follow-up of patients treated with HFNC
- Volunteering to participate in research
Key exclusion criteria (2 listed)
- Those who have received in-service training on HFNC implementation
- Those who work as responsible nurses or training nurses in the clinics where the research will be conducted
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 |
|---|---|---|
| TrainingOne month after the pre-test, the post-test will be administered to the nurses who will be in the control group. Nurses who will be in the experimental group will be given training after the pre-test. A post-test will be administered one month after the training. | Other | Test after post-test training |
Primary outcome
Knowledge Level - Education Form- Questionnaire
Time frame: One month after training
To increase the knowledge level of nurses about oxygen therapy with high flow nasal cannula.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Background: PubMed 29995143Colleti Junior J, Longui TE, Carvalho WB. HIGH-FLOW NASAL CANNULA POST-TRACHEAL EXTUBATION IN A CHILD WITH UPPER AIRWAY OBSTRUCTION: CASE REPORT. Rev Paul Pediatr. 2018 Jul-Sep;36(3):372-375. doi: 10.1590/1984-0462/;2018;36;3;00010. Epub 2018 Jul 10.
- Individual participant dataSharing planned: No
Related trials for Pediatric
Active, not recruiting
Pediatric Parenting Support in Flint
Healthy, Family Research
Not yet recruitingObservational study
Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS)
RecruitingObservational study
Pediatric Research in the Outpatient Setting CoHort
Factors Associated With a Child's Development of Interaction and Communication Skills and Measures Taken, Reported Stress Level of the Parents of a Newborn and Measures Taken
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
Active, not recruitingObservational study
Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy
Cerebral Palsy
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.
Aslı ALACA principal investigator
Study Principal Investigator
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Pediatric, run by Izmir Katip Celebi University.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aslı Alaca (+905052741676, alaca_asli_1992@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Level - Education Form- Questionnaire (time frame: One month after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05362279, which also lists 1 linked publication.
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 5 May 2022.