Clinical trial NCT05318885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma Attack
Asthma in Children
Asthma Acute
Asthma
Keywords: Asthma attack
Child
Nurse
Nebulization
Chest Pain
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 86
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Oxygen Saturation
timeFrame: 90 minute
measure: Change in respiratory rate
timeFrame: 90 minute
measure: Change in Pulse Rate
timeFrame: 90 minute
measure: Change in chest pain score
timeFrame: 90 minute
measure: Change in anxiety score
timeFrame: 90 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Gamze KAŞ ALAY, Msc
role: PRINCIPAL_INVESTIGATOR
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