Fear AnxietyNCT07713225
Preparation Methods on PFT Performance
A study testing Verbal Instruction with Demonstration and Animation-Assisted Preparation in people with Fear Anxiety and Pulmonary, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear Anxiety, Pulmonary, Performance Assessment
- What is being tested?
- Verbal Instruction with Demonstration and Animation-Assisted Preparation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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- Withdrawn criteria:
- Participants were withdrawn from the study if they completed fewer than three acceptable spirometry maneuvers, discontinued the procedure before completion, or requested to withdraw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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Three Preparation Methods on Pulmonary Function Test Performance and Procedure-Related Fear in Children: A Three-Arm Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Fear Anxiety, Pulmonary, Performance Assessment
- Being tested
- Verbal Instruction with Demonstration, Animation-Assisted Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal Instruction with DemonstrationBehavioural
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 PreparationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Verbal Instruction with Demonstration Group (Experimantal group 1) | Experimental | 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. Receives: Behavioral: Verbal Instruction with Demonstration |
| Animation-Assisted Preparation Group (Experimantal group 2): | Experimental | 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. Receives: Behavioral: Animation-Assisted Preparation |
| Verbal Instruction Group (Control) | No intervention | Children assigned to the control group received the unit's standard pre-spirometry preparation, which consisted of routine verbal instruction delivered by the certified pediatric pulmonary function nurse. The explanation included the purpose of the test, the correct performance of the spirometry maneuver, and the behaviors expected during the procedure. Children were encouraged to ask questions before testing. No additional demonstration or animation-assisted preparation was provided. The intervention lasted approximately 2-3 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Characteristics Form
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.
Measured: First measurement-5. minutes before the start of the pulmonary function test
Children's Fear Scale
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.
Measured: First measurement- 1 minutes before the start of the pulmonary function test
Secondary outcomes (16)
Children's Fear Scale
Procedure-related fear was reassessed within one minute after completion of the spirometry procedure using the Children's Fear Scale.
Measured: Second measurement- 1 minutes after the start of the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
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.
Measured: First FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: Second FVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: Third FVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: First FIVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: Second FIVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: Third FIVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: First FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form
Measured: Second FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: Third FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: First FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form
Measured: Second FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: Third FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the first acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: First FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the second acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form
Measured: Second FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Pulmonary function parameters obtained from the third acceptable spirometry maneuvers were recorded using the Pulmonary Function Test Parameters Form.
Measured: Third FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start15 Mar 2022
- Primary completion15 Nov 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Küçükoğlu, Selcuk University
- Investigators
- Sibel Kucukoglu, Prof, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713225
- Sponsor's protocol ID
- 2026/07
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gunes SN, Kucukoglu S. Effectiveness of three preparation methods on pulmonary function test performance and procedure-related fear in children: A three-arm randomized controlled trial. J Pediatr Nurs. 2026 Oct 20:S0882-5963(26)00524-5. doi: 10.1016/j.pedn.2026.10.016. Online ahead of print.
PubMed 42901835
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Three Preparation Methods on Pulmonary Function Test Performance and Procedure-Related Fear in Children: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07713225
- Acronym / sponsor ID
- 2026/07
- Conditions
- Fear Anxiety, Pulmonary, Performance Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Verbal Instruction with Demonstration Group (Experimantal group 1) | Experimental | Behavioral: Verbal Instruction with DemonstrationChildren 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 Group (Experimantal group 2): | Experimental | Behavioral: Animation-Assisted PreparationChildren 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. |
| Verbal Instruction Group (Control) | No intervention | –Children assigned to the control group received the unit's standard pre-spirometry preparation, which consisted of routine verbal instruction delivered by the certified pediatric pulmonary function nurse. The explanation included the purpose of the test, the correct performance of the spirometry maneuver, and the behaviors expected during the procedure. Children were encouraged to ask questions before testing. No additional demonstration or animation-assisted preparation was provided. The intervention lasted approximately 2-3 minutes. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal Instruction with DemonstrationChildren 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. | Behavioural | Verbal Instruction with Demonstration Group (Experimantal group 1) |
| Animation-Assisted PreparationChildren 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. | Behavioural | Animation-Assisted Preparation Group (Experimantal group 2): |
Primary outcome
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.
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.
16 secondary outcomes
Children's Fear Scale
Time frame: Second measurement- 1 minutes after the start of the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: First FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Second FVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Third FVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: First FIVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Second FIVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Third FIVC (%) measurement- Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: First FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Second FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Third FEV 1 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: First FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Second FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Third FEV1/FVC (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: First FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Second FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
The Pulmonary Function Test (PFT) Parameters Form
Time frame: Third FEF 25 - 75 (%) measurement -Within 1 minutes after the fineshed the pulmonary function test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Derived from this study: PubMed 42901835Gunes SN, Kucukoglu S. Effectiveness of three preparation methods on pulmonary function test performance and procedure-related fear in children: A three-arm randomized controlled trial. J Pediatr Nurs. 2026 Oct 20:S0882-5963(26)00524-5. doi: 10.1016/j.pedn.2026.10.016. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Kucukoglu, Prof principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal Instruction with Demonstration and Animation-Assisted Preparation in people with Fear Anxiety and Pulmonary, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive Characteristics Form (time frame: First measurement-5. minutes before the start of the pulmonary function test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.