NCT05318885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
Last Updated

April 8, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

March 6, 2022

Last Update Submit

April 1, 2022

Conditions

Keywords

Asthma attackChildNurseNebulizationChest Pain

Outcome Measures

Primary Outcomes (5)

  • Change in Oxygen Saturation

    Oxygen saturation will be monitored

    90 minute

  • Change in respiratory rate

    Respiratory rate will be monitored

    90 minute

  • Change in Pulse Rate

    Heart rate will be monitored

    90 minute

  • Change in chest pain score

    Pain score will be evaluated with The faces pain scale-revised (FPS-R).

    90 minute

  • Change in anxiety score

    Anxiety score will be evaluated with The children state anxiety scale (CSA).

    90 minute

Study Arms (2)

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.

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.

Interventions

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.

Forward leaning position

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

  • 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.

    PMID: 25263689BACKGROUND
  • 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.

    PMID: 30362669BACKGROUND
  • Kocaaslan 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.

    PMID: 30887669BACKGROUND
  • Camargo 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.

    PMID: 14583926BACKGROUND
  • Iramain 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.

    PMID: 30672140BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 22241044BACKGROUND
  • 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. doi: 10.1164/arrd.1980.122.2.201. No abstract available.

    PMID: 7416599BACKGROUND
  • Tuncer 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

AsthmaChest Pain

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gamze KAŞ ALAY, Msc

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 6, 2022

First Posted

April 8, 2022

Study Start

October 15, 2019

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

April 8, 2022

Record last verified: 2022-04

Locations