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COMPLETED
NCT07713225
NA

Preparation Methods on PFT Performance

Sponsor: Selcuk University

View on ClinicalTrials.gov

Summary

Background: Successful spirometry in children depends on adequate cooperation and correct performance of respiratory maneuvers. Although several preparation strategies have been proposed, evidence comparing their effects on both spirometry performance and procedure-related fear remains limited. This study compared the effects of routine verbal instruction, verbal instruction with demonstration, and animation-assisted preparation on pulmonary function test (PFT) performance and procedure-related fear in children undergoing spirometry. Methods: This three-arm randomized controlled trial was conducted in the Pediatric Pulmonary Function Test Unit of a tertiary children's allergy and immunology outpatient clinic. Ninety-six children aged 6-12 years referred for spirometry were allocated using stratified randomization to routine verbal instruction (control, n = 32), verbal instruction with demonstration (n = 32), or animation-assisted preparation (n = 32). Data were collected using Descriptive Characteristics Form, Pulmonary Function Test Parameters Form, and Children's Fear Scale (CFS). Pulmonary function parameters were recorded during the first three acceptable spirometry maneuvers, and procedure-related fear was assessed immediately before and after testing.

Official title: Effectiveness of Three Preparation Methods on Pulmonary Function Test Performance and Procedure-Related Fear in Children: A Three-Arm Randomized Controlled Trial

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2022-03-15

Completion Date

2023-11-15

Last Updated

2026-07-20

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Verbal Instruction with Demonstration

Children allocated to this group received nurse-led verbal instruction supplemented with demonstration before spirometry. In addition to the routine verbal explanation, the researcher demonstrated each step of the spirometry maneuver by performing it on herself. The demonstration included correct placement of the nose clip and mouthpiece, maximal inspiration, rapid and forceful expiration sustained for at least 6 seconds, and a final maximal inspiration. After the demonstration, children were encouraged to ask questions and subsequently performed the spirometry procedure under the guidance of the researcher. The intervention lasted approximately 2-3 minutes.

BEHAVIORAL

Animation-Assisted Preparation

Children allocated to this group received animation-assisted preparation in addition to the routine verbal instruction. A Pediatric Incentive Fish Animation specifically designed to prepare children for pulmonary function testing was used as the intervention. Before spirometry, the researcher introduced the animation and explained that a forceful and continuous expiration would enable the animated fish to swim toward its home, whereas interrupting expiration would stop the fish before reaching its destination. The researcher then demonstrated the correct use of the animation while simultaneously performing the spirometry maneuver. During spirometry, children used the animation as real-time visual feedback while performing their first three acceptable maneuvers. The intervention lasted approximately 3-4 minutes.

Locations (1)

Selcuk University

Konya, Türkiye, Turkey (Türkiye)