The Effect of Nebulization Positions in Asthmatic Children

Asthma Clinical Trial

Official title:

Effect of Forward-leaning Position on Vital Signs, Pain and Anxiety of Children With Acute Asthma Attacks: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318885
• Other study ID #: 0000-0001-7140-6540
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: April 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma
• Asthma Acute
• Asthma Attack
• Asthma in Children

Intervention

Other:
• A Randomized Controlled Study
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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

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

Camargo CA Jr, Spooner CH, Rowe BH. Continuous versus intermittent beta-agonists in the treatment of acute asthma. Cochrane Database Syst Rev. 2003;(4):CD001115. Review. — View Citation

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

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

Iramain R, Castro-Rodriguez JA, Jara A, Cardozo L, Bogado N, Morinigo R, De Jesús 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. — View Citation

Kocaaslan EN, Akgün 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. — View Citation

Korkmaz M, Kizilci S. Posture and its 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

Martinez JA, Rodrigues HB, Portelinha AM. A novel position for postural relief of dyspnea. J Bras Pneumol. 2011 Nov-Dec;37(6):829-30. English, Portuguese. — View Citation

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

Myint 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

Sharp 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. — View Citation

Sheldon 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. Review. — View Citation

Tuncer M, Khorshtd L. Obez bireylerde pozisyonlarin oksijen satürasyonuna etkisi. Ege Üniversitesi Hemsirelik Fakültesi Dergisi 2018;34:54-65. https://dergipark.org.tr/tr/download/article-file/456669

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oxygen Saturation	Oxygen saturation will be monitored	90 minute
Primary	Change in respiratory rate	Respiratory rate will be monitored	90 minute
Primary	Change in Pulse Rate	Heart rate will be monitored	90 minute
Primary	Change in chest pain score	Pain score will be evaluated with The faces pain scale-revised (FPS-R).	90 minute
Primary	Change in anxiety score	Anxiety score will be evaluated with The children state anxiety scale (CSA).	90 minute