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Completed

NCT Number: NCT07713225

Preparation Methods on PFT Performance

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.

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Key information

Conditions

Fear Anxiety Performance Assessment Pulmonary

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Türkiye, 42130, Turkey (Türkiye)

About this study

This study is a three-arm, parallel-group, randomized controlled trial designed to evaluate the effectiveness of three different preparation methods for pulmonary function testing (PFT) in children aged 6-12 years.

Eligible children referred for spirometry at the Pediatric Pulmonary Function Test Unit are randomly assigned to one of three groups: (1) routine verbal instruction (control group), (2) nurse-led verbal instruction with demonstration, or (3) animation-assisted preparation using a pediatric incentive fish animation integrated into the spirometry system. Randomization is performed using a computer-generated stratified block randomization sequence with allocation concealment through sequentially numbered, sealed opaque envelopes.

All participants receive routine pre-spirometry preparation according to current ATS/ERS recommendations. Children in the demonstration group receive an additional nurse-led demonstration of the spirometry maneuver before testing. Children in the animation-assisted group receive a brief explanation of the animation and perform spirometry with real-time visual feedback provided by the animated incentive program during the first three acceptable maneuvers.

The primary outcomes are pulmonary function test parameters, including forced vital capacity (FVC), forced inspiratory vital capacity (FIVC), forced expiratory volume in one second (FEV₁), FEV₁/FVC ratio, forced expiratory flow between 25% and 75% of vital capacity (FEF25-75), and peak expiratory flow (PEF), recorded from the first three acceptable spirometry maneuvers. Procedure-related fear is assessed before and after spirometry using the Children's Fear Scale (CFS).

The study aims to determine whether nurse-led demonstration or animation-assisted preparation improves spirometry performance and reduces children's procedure-related fear compared with routine verbal instruction. Outcomes will be compared among the three groups following completion of data collection.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children were eligible for inclusion if they were 6-12 years of age and had no cognitive, visual, or hearing impairments that could interfere with understanding or performing the spirometry procedure.

Exclusion criteria

  • Children were excluded if they were unable to understand or communicate in Turkish, had communication difficulties, declined to participate, had conditions that could interfere with spirometry performance (e.g., cleft lip, cleft palate, jaw anomalies, or oral/dental problems preventing an adequate seal around the mouthpiece), or had previously viewed or used the Fish Animation employed in the animation-assisted preparation to avoid familiarity and learning effects.

Withdrawn criteria:

  • Participants were withdrawn from the study if they completed fewer than three acceptable spirometry maneuvers, discontinued the procedure before completion, or requested to withdraw during testing.

Treatment and study plan

Verbal Instruction with Demonstration

Behavioral

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.

Animation-Assisted Preparation

Behavioral

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.

Primary outcomes

  1. Descriptive Characteristics Form

    Time frame: First measurement-5. minutes before the start of the pulmonary function test

    This form was developed by the researchers based on the relevant literature . The form included questions regarding the child's age, sex, school grade, perceived family income, place of residence, family structure, number of siblings, height, weight, presence of chronic disease, medical diagnosis (if any), and previous pulmonary function testing experience.

  2. Children's Fear Scale

    Time frame: First measurement- 1 minutes before the start of the pulmonary function test

    Children's fear was assessed using the Children's Fear Scale (CFS) developed by McMurtry et al. . The CFS is a single-item, self-report instrument consisting of five gender-neutral facial expressions representing increasing levels of fear. Children are asked to select the face that best reflects how they feel, with scores ranging from 0 (no fear) to 4 (highest level of fear); higher scores indicate greater procedure-related fear.

    Before the intervention, children's baseline procedure-related fear was independently assessed by both the researcher and the clinic nurse using the Children's Fear Scale, and the mean score was recorded.

Secondary outcomes

  1. Children's Fear Scale

    Time frame: Second measurement- 1 minutes after the start of the pulmonary function test

    Procedure-related fear was reassessed within one minute after completion of the spirometry procedure using the Children's Fear Scale.

  2. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: First FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    This form was developed by the researchers based on the relevant literature . The form was used to record the results of the first three acceptable spirometry maneuvers, including forced vital capacity (FVC), forced inspiratory vital capacity (FIVC), forced expiratory volume in one second (FEV₁), FEV₁/FVC ratio, forced expiratory flow at 25-75% of vital capacity (FEF₂₅-₇₅), and peak expiratory flow (PEF).

    All spirometry procedures were performed by the principal investigator, who was the certified pediatric pulmonary function nurse responsible for the Pulmonary Function Test Unit. Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  3. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Second FVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  4. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Third FVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  5. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: First FIVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  6. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Second FIVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  7. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Third FIVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  8. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: First FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  9. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Second FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form

  10. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Third FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  11. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: First FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  12. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Second FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form

  13. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Third FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  14. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: First FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

  15. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Second FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form

  16. The Pulmonary Function Test (PFT) Parameters Form

    Time frame: Third FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test

    Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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