The Effect of Nebulization Positions in Asthmatic Children

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Completed

CT.gov ID

NCT05318885

Collaborator

(none)

Enrollment

Location

Arms

4.2

Actual Duration (Months)

20.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Attack Asthma in Children Asthma Acute Asthma	Other: A Randomized Controlled Study	N/A

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

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized controlled studyA randomized controlled study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 15, 2019

Actual Primary Completion Date :

Feb 20, 2020

Actual Study Completion Date :

Feb 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Forward leaning position 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 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.
No Intervention: Fowler position The children in asthma attacks were administered nebulization three times, during which the control group children in the routine Fowler's position.

Arm

Intervention/Treatment

Experimental: Forward leaning position

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

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.

No Intervention: Fowler position

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

Outcome Measures

Primary Outcome Measures

Change in Oxygen Saturation [90 minute]
Oxygen saturation will be monitored
Change in respiratory rate [90 minute]
Respiratory rate will be monitored
Change in Pulse Rate [90 minute]
Heart rate will be monitored
Change in chest pain score [90 minute]
Pain score will be evaluated with The faces pain scale-revised (FPS-R).
Change in anxiety score [90 minute]
Anxiety score will be evaluated with The children state anxiety scale (CSA).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts 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.