Asthma AttackNCT05318885
The Effect of Nebulization Positions in Asthmatic Children
A study of Asthma Attack and Asthma in Children, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to establish the effect on pulse rate, oxygen saturation, respiratory rate, pain and anxiety levels of Fowler's and the forward-leaning positions during nebulization in children experiencing asthma attacks. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma Attack, Asthma in Children, Asthma Acute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2019to 20 Feb 2020
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be between 6-11 ages,
- Having a body temperature below 37.2°C at admission,
- Having been prescribed nebulized salbutamol by the physician during data collection,
- Having not using bronchodilators or corticosteroid drugs within the last 6 hours,
- Having no other respiratory system disease,
- Verbal and written consent of the child and parent to participate in the study.
Who cannot join
- Administering drugs other than nebulized salbutamol to the child during data collection,
- Having an obstacle for positioning (Lordosis, kyphosis, scoliosis, chest wall deformities, previous surgical procedure, etc.),
- Child and parent not knowing Turkish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Forward-leaning Position on Vital Signs, Pain and Anxiety of Children With Acute Asthma Attacks: A Randomized Controlled Study
The purpose of this study was to establish the effect on pulse rate, oxygen saturation, respiratory rate, pain and anxiety levels of Fowler's and the forward-leaning positions during nebulization in children experiencing asthma attacks.
Read the detailed description
In the first stage, data on the children who agreed to participate in the study were recorded on the "Patient Identification Form" 10 minutes before the procedure by the researcher during a face-to-face interview. The children's body temperature, oxygen saturation, pulse rate and respiratory rate were measured. Upon explaining the FPS-R, the children were asked whether they had experienced pain before treatment, and to point at the pain level felt from among the faces on the scale. Then, CSA was explained and the children, and their level of anxiety on the scale was recorded. The pre-nebulization findings were recorded.
In the second stage, the salbutamol therapy prescribed by the physician was administered to the participating children with a nebulizer three times at 20-minute intervals. During nebulization, the study group patients were placed in forward-leaning position, placing a pillow on their knees, while the control group was placed in Fowler's position on a chair. Nebulization took an average of 10 minutes for each child. Oxygen saturation, pulse and respiratory rate were recorded immediately after the mask was removed. The children were allowed to rest for 20 minutes in Fowler's position.
In the third stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following a 10-minute second nebulization. The values determined were recorded, and the children were allowed to rest for 20 minutes in Fowler's position.
In the fourth stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following the 10-minute third nebulization. The children were asked whether they had pain, and to point at the pain level represented by the faces on the scale. The patients then marked their level of anxiety on the CSA. The post-nebulization findings were recorded.
- Conditions
- Asthma Attack, Asthma in Children, Asthma Acute, Asthma
- Being tested
- A Randomized Controlled Study
- Keywords
- Asthma attack, Child, Nurse, Nebulization, Chest Pain
- Medical subject headings
- Asthma, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Randomized Controlled StudyOther
For forward-leaning position, the child is first placed on a suitable chair with a soft pillow on their knees. The child will remain in the same position for the duration of the nebulization, and the pillow provides support, ensuring the child does not get tired. The child leans forward at an angle of 45°, places their arms on the pillow as shown in the figure and holds their head upright with their eyes facing forward (slight hyperextension). The upright head position of the child prevents spillage of the liquid medicine from the nebulizer chamber.
| Study group | Role | What they receive |
|---|---|---|
| Forward leaning position | Experimental | The children in asthma attacks were administered nebulization three times, during which the study group children were placed in the forward-leaning position. Receives: Other: A Randomized Controlled Study |
| Fowler position | No intervention | The children in asthma attacks were administered nebulization three times, during which the control group children in the routine Fowler's position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Saturation
Oxygen saturation will be monitored
Measured: 90 minute
Change in respiratory rate
Respiratory rate will be monitored
Measured: 90 minute
Change in Pulse Rate
Heart rate will be monitored
Measured: 90 minute
Change in chest pain score
Pain score will be evaluated with The faces pain scale-revised (FPS-R).
Measured: 90 minute
Change in anxiety score
Anxiety score will be evaluated with The children state anxiety scale (CSA).
Measured: 90 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start15 Oct 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Asthma AttackStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled study
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Kas Alay, Kastamonu University
- Investigators
- Gamze KAŞ ALAY, Msc, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318885
- Sponsor's protocol ID
- 0000-0001-7140-6540
- Status last verified
- Apr 2022
- First submitted
- 6 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wilder C, Shiralkar S. Childhood asthma in the emergency department: an audit. Int Emerg Nurs. 2015 Apr;23(2):197-202. doi: 10.1016/j.ienj.2014.09.001. Epub 2014 Sep 6.
PubMed 25263689Sheldon G, Heaton PA, Palmer S, Paul SP. Nursing management of paediatric asthma in emergency departments. Emerg Nurse. 2018 Nov 6;26(4):32-42. doi: 10.7748/en.2018.e1770. Epub 2018 Oct 17.
PubMed 30362669Kocaaslan EN, Akgun Kostak M. Effect of disease management education on the quality of life and self-efficacy levels of children with asthma. J Spec Pediatr Nurs. 2019 Apr;24(2):e12241. doi: 10.1111/jspn.12241. Epub 2019 Mar 19.
PubMed 30887669Camargo CA Jr, Spooner CH, Rowe BH. Continuous versus intermittent beta-agonists in the treatment of acute asthma. Cochrane Database Syst Rev. 2003;2003(4):CD001115. doi: 10.1002/14651858.CD001115.
PubMed 14583926Iramain R, Castro-Rodriguez JA, Jara A, Cardozo L, Bogado N, Morinigo R, De Jesus R. Salbutamol and ipratropium by inhaler is superior to nebulizer in children with severe acute asthma exacerbation: Randomized clinical trial. Pediatr Pulmonol. 2019 Apr;54(4):372-377. doi: 10.1002/ppul.24244. Epub 2019 Jan 22.
PubMed 30672140Myint WW, Htay MNN, Soe HHK, Renjue L, Shirying G, Yuan NSB, et al. Effect of body positions on lungs volume in asthmatic patients: A cross-sectional study. Journal of Advances in Medical and Pharmaceutical Sciences 2017;13(4):1-6. http://doi.org/10.9734/JAMPS/2017/33901
Ganapathi LV, Vinoth S. The estimation of pulmonary functions in various body postures in normal subjects. International Journal of Advances in Medicine 2015;2(3):250-4. https://doi.org/10.18203/2349-3933.IJAM20150554
Martinez JA, Rodrigues HB, Portelinha AM. A novel position for postural relief of dyspnea. J Bras Pneumol. 2011 Nov-Dec;37(6):829-30. doi: 10.1590/s1806-37132011000600020. No abstract available. English, Portuguese.
PubMed 22241044Sharp JT, Drutz WS, Moisan T, Foster J, Machnach W. Postural relief of dyspnea in severe chronic obstructive pulmonary disease. Am Rev Respir Dis. 1980 Aug;122(2):201-11. doi: 10.1164/arrd.1980.122.2.201. No abstract available.
PubMed 7416599Tuncer M, Khorshtd L. Obez bireylerde pozisyonların oksijen satürasyonuna etkisi. Ege Üniversitesi Hemşirelik Fakültesi Dergisi 2018;34:54-65. https://dergipark.org.tr/tr/download/article-file/456669
Korkmaz M, Kızılcı S. Posture and ıts effect on peripheral oxygen saturation, and some hemodynamic parameters in patients with heart failure. Turkiye Klinikleri Journal of Nursing Science 2012;4(2):85-93. https://www.turkiyeklinikleri.com/article/posture-and-its-effect-on-peripheral-oxygen-saturation-and-some-hemodynamic-parameters-in-patients-with-heart-failure-63546.html
Baysal E, Midilli ST, Ergin E. Effects of different position changes on hemodynamic parameters and dyspnea severity in patients with dyspnea. Clinical and Experimental Health Sciences 2018;8:261-7. doi: 10.5152/clinexphealthsci.2017.751
Mohammed J, Abdulateef A, Shittu A, Sumaila FG. Effect of different body positioning on lung function variables among patients with bronchial asthma. Archives of Physiotherapy and Global Researches 2017;21(3):7-12. http://apgr.wssp.edu.pl/wp-content/uploads/2017/12/APGR-21-3-A.pdf
Hojat B, Mahdi E. Effect of different sitting posture on pulmonary function in students. Journal of Physiology and Pathophysiology 2011;2(2):29-33. https://academicjournals.org/article/article1381307359_Hojat%20and%20mahdi%20PDF.pdf
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Forward-leaning Position on Vital Signs, Pain and Anxiety of Children With Acute Asthma Attacks: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05318885
- Acronym / sponsor ID
- 0000-0001-7140-6540
- Conditions
- Asthma Attack, Asthma in Children, Asthma Acute, Asthma
- Keywords
- Asthma attack, Child, Nurse, Nebulization, Chest Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 8 Apr 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.
The purpose of this study was to establish the effect on pulse rate, oxygen saturation, respiratory rate, pain and anxiety levels of Fowler's and the forward-leaning positions during nebulization in children experiencing asthma attacks.
Detailed description
In the first stage, data on the children who agreed to participate in the study were recorded on the "Patient Identification Form" 10 minutes before the procedure by the researcher during a face-to-face interview. The children's body temperature, oxygen saturation, pulse rate and respiratory rate were measured. Upon explaining the FPS-R, the children were asked whether they had experienced pain before treatment, and to point at the pain level felt from among the faces on the scale. Then, CSA was explained and the children, and their level of anxiety on the scale was recorded. The pre-nebulization findings were recorded.
In the second stage, the salbutamol therapy prescribed by the physician was administered to the participating children with a nebulizer three times at 20-minute intervals. During nebulization, the study group patients were placed in forward-leaning position, placing a pillow on their knees, while the control group was placed in Fowler's position on a chair. Nebulization took an average of 10 minutes for each child. Oxygen saturation, pulse and respiratory rate were recorded immediately after the mask was removed. The children were allowed to rest for 20 minutes in Fowler's position.
In the third stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following a 10-minute second nebulization. The values determined were recorded, and the children were allowed to rest for 20 minutes in Fowler's position.
In the fourth stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following the 10-minute third nebulization. The children were asked whether they had pain, and to point at the pain level represented by the faces on the scale. The patients then marked their level of anxiety on the CSA. The post-nebulization findings were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Forward leaning position | Experimental | Other: A Randomized Controlled StudyThe children in asthma attacks were administered nebulization three times, during which the study group children were placed in the forward-leaning position. |
| Fowler position | No intervention | –The children in asthma attacks were administered nebulization three times, during which the control group children in the routine Fowler's position. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- To be between 6-11 ages,
- Having a body temperature below 37.2°C at admission,
- Having been prescribed nebulized salbutamol by the physician during data collection,
- Having not using bronchodilators or corticosteroid drugs within the last 6 hours,
- Having no other respiratory system disease,
Key exclusion criteria (3 listed)
- Administering drugs other than nebulized salbutamol to the child during data collection,
- Having an obstacle for positioning (Lordosis, kyphosis, scoliosis, chest wall deformities, previous surgical procedure, etc.),
- Child and parent not knowing Turkish.
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 |
|---|---|---|
| A Randomized Controlled StudyFor forward-leaning position, the child is first placed on a suitable chair with a soft pillow on their knees. The child will remain in the same position for the duration of the nebulization, and the pillow provides support, ensuring the child does not get tired. The child leans forward at an angle of 45°, places their arms on the pillow as shown in the figure and holds their head upright with their eyes facing forward (slight hyperextension). The upright head position of the child prevents spillage of the liquid medicine from the nebulizer chamber. | Other | Forward leaning position |
Primary outcome
Change in Oxygen Saturation
Time frame: 90 minute
Oxygen saturation will be monitored
Change in respiratory rate
Time frame: 90 minute
Respiratory rate will be monitored
Change in Pulse Rate
Time frame: 90 minute
Heart rate will be monitored
Change in chest pain score
Time frame: 90 minute
Pain score will be evaluated with The faces pain scale-revised (FPS-R).
Change in anxiety score
Time frame: 90 minute
Anxiety score will be evaluated with The children state anxiety scale (CSA).
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 8 Apr 2022.
- Background: PubMed 25263689Wilder C, Shiralkar S. Childhood asthma in the emergency department: an audit. Int Emerg Nurs. 2015 Apr;23(2):197-202. doi: 10.1016/j.ienj.2014.09.001. Epub 2014 Sep 6.
- Background: PubMed 30362669Sheldon G, Heaton PA, Palmer S, Paul SP. Nursing management of paediatric asthma in emergency departments. Emerg Nurse. 2018 Nov 6;26(4):32-42. doi: 10.7748/en.2018.e1770. Epub 2018 Oct 17.
- Background: PubMed 30887669Kocaaslan EN, Akgun Kostak M. Effect of disease management education on the quality of life and self-efficacy levels of children with asthma. J Spec Pediatr Nurs. 2019 Apr;24(2):e12241. doi: 10.1111/jspn.12241. Epub 2019 Mar 19.
- Background: PubMed 14583926Camargo CA Jr, Spooner CH, Rowe BH. Continuous versus intermittent beta-agonists in the treatment of acute asthma. Cochrane Database Syst Rev. 2003;2003(4):CD001115. doi: 10.1002/14651858.CD001115.
- Background: PubMed 30672140Iramain R, Castro-Rodriguez JA, Jara A, Cardozo L, Bogado N, Morinigo R, De Jesus R. Salbutamol and ipratropium by inhaler is superior to nebulizer in children with severe acute asthma exacerbation: Randomized clinical trial. Pediatr Pulmonol. 2019 Apr;54(4):372-377. doi: 10.1002/ppul.24244. Epub 2019 Jan 22.
- BackgroundMyint WW, Htay MNN, Soe HHK, Renjue L, Shirying G, Yuan NSB, et al. Effect of body positions on lungs volume in asthmatic patients: A cross-sectional study. Journal of Advances in Medical and Pharmaceutical Sciences 2017;13(4):1-6. http://doi.org/10.9734/JAMPS/2017/33901
- BackgroundGanapathi LV, Vinoth S. The estimation of pulmonary functions in various body postures in normal subjects. International Journal of Advances in Medicine 2015;2(3):250-4. https://doi.org/10.18203/2349-3933.IJAM20150554
- Background: PubMed 22241044Martinez JA, Rodrigues HB, Portelinha AM. A novel position for postural relief of dyspnea. J Bras Pneumol. 2011 Nov-Dec;37(6):829-30. doi: 10.1590/s1806-37132011000600020. No abstract available. English, Portuguese.
- Background: PubMed 7416599Sharp JT, Drutz WS, Moisan T, Foster J, Machnach W. Postural relief of dyspnea in severe chronic obstructive pulmonary disease. Am Rev Respir Dis. 1980 Aug;122(2):201-11. doi: 10.1164/arrd.1980.122.2.201. No abstract available.
- BackgroundTuncer M, Khorshtd L. Obez bireylerde pozisyonların oksijen satürasyonuna etkisi. Ege Üniversitesi Hemşirelik Fakültesi Dergisi 2018;34:54-65. https://dergipark.org.tr/tr/download/article-file/456669
- BackgroundKorkmaz M, Kızılcı S. Posture and ıts effect on peripheral oxygen saturation, and some hemodynamic parameters in patients with heart failure. Turkiye Klinikleri Journal of Nursing Science 2012;4(2):85-93. https://www.turkiyeklinikleri.com/article/posture-and-its-effect-on-peripheral-oxygen-saturation-and-some-hemodynamic-parameters-in-patients-with-heart-failure-63546.html
- BackgroundBaysal E, Midilli ST, Ergin E. Effects of different position changes on hemodynamic parameters and dyspnea severity in patients with dyspnea. Clinical and Experimental Health Sciences 2018;8:261-7. doi: 10.5152/clinexphealthsci.2017.751
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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.
Gamze KAŞ ALAY, Msc principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Asthma Attack and Asthma in Children, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 6 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 8 Apr 2022. 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 Turkey (Türkiye). 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.
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?
Change in Oxygen Saturation (time frame: 90 minute). The study lists 5 primary outcomes in all. 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 NCT05318885, which also lists 14 linked publications.
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 8 Apr 2022.