Fear Anxiety, Performance Assessment, Pulmonary
Conditions
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALVerbal 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.
BEHAVIORALAnimation-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.
Sponsors
Selcuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Because the interventions were delivered by the researcher, blinding of the intervention provider was not feasible. Participants remained blinded to their group allocation until the intervention was initiated. However, blinding could not be maintained thereafter because participants were aware of the preparation strategy they received during the intervention. Group allocation codes (A, B, and C) were used during data entry, and statistical analyses were performed by an independent statistician who was blinded to group allocation.
Intervention model description
Participants were assigned to the three study groups using stratified block randomization to ensure balanced distribution of important prognostic factors across the groups. Sex (female/male) and previous pulmonary function testing experience (yes/no) were selected as stratification variables based on previous literature. Within each stratum, participants were randomized using permuted blocks generated from a computer-based random number sequence (Random.org). The three intervention groups were coded as A (verbal instruction), B (nurse-led verbal instruction with demonstration), and C (animation-assisted preparation).
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive Characteristics Form | 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. |
| Children's Fear Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Children's Fear Scale | 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. |
| The Pulmonary Function Test (PFT) Parameters Form | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORSibel Kucukoglu, Prof
Selcuk University
Outcome results
None listed