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The Effect of Nebulization Positions in Asthmatic Children

Primary Purpose

Asthma Attack, Asthma in Children, Asthma Acute

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
A Randomized Controlled Study
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma Attack focused on measuring Asthma attack, Child, Nurse, Nebulization, Chest Pain

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul University-Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Forward leaning position

Fowler position

Arm Description

The children in asthma attacks were administered nebulization three times, during which the study group children were placed in the forward-leaning position.

The children in asthma attacks were administered nebulization three times, during which the control group children in the routine Fowler's position.

Outcomes

Primary Outcome Measures

Change in Oxygen Saturation
Oxygen saturation will be monitored
Change in respiratory rate
Respiratory rate will be monitored
Change in Pulse Rate
Heart rate will be monitored
Change in chest pain score
Pain score will be evaluated with The faces pain scale-revised (FPS-R).
Change in anxiety score
Anxiety score will be evaluated with The children state anxiety scale (CSA).

Secondary Outcome Measures

Full Information

First Posted
March 6, 2022
Last Updated
April 1, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05318885
Brief Title
The Effect of Nebulization Positions in Asthmatic Children
Official Title
Effect of Forward-leaning Position on Vital Signs, Pain and Anxiety of Children With Acute Asthma Attacks: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Attack, Asthma in Children, Asthma Acute, Asthma
Keywords
Asthma attack, Child, Nurse, Nebulization, Chest Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Forward leaning position
Arm Type
Experimental
Arm Description
The children in asthma attacks were administered nebulization three times, during which the study group children were placed in the forward-leaning position.
Arm Title
Fowler position
Arm Type
No Intervention
Arm Description
The children in asthma attacks were administered nebulization three times, during which the control group children in the routine Fowler's position.
Intervention Type
Other
Intervention Name(s)
A Randomized Controlled Study
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Oxygen Saturation
Description
Oxygen saturation will be monitored
Time Frame
90 minute
Title
Change in respiratory rate
Description
Respiratory rate will be monitored
Time Frame
90 minute
Title
Change in Pulse Rate
Description
Heart rate will be monitored
Time Frame
90 minute
Title
Change in chest pain score
Description
Pain score will be evaluated with The faces pain scale-revised (FPS-R).
Time Frame
90 minute
Title
Change in anxiety score
Description
Anxiety score will be evaluated with The children state anxiety scale (CSA).
Time Frame
90 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamze KAŞ ALAY, Msc
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpaşa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25263689
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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The Effect of Nebulization Positions in Asthmatic Children

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