Pediatric Acute Upper Respiratory Tract InfectionCALM-INHNCT07371026
The Effect of Using Distractor Cards and Thermochromic Cards on Pain, Fear, Anxiety and Procedure Time in Children Receiving Inhaler Therapy
A study testing thermochromic card and distraction card in people with Pediatric Acute Upper Respiratory Tract Infection and Pediatric, run by Muhammed Ata Nur GEÇER.
Trial summary
THE EFFECT OF USİNG DİSTRACTOR CARDS AND THERMOCHROMİC CARDS ON PAİN, FEAR, ANXİETY AND PROCEDURE TİME İN CHİLDREN RECEİVİNG INHALER THERAPY. Respiratory illnesses in children are a leading cause of childhood morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Pediatric Acute Upper Respiratory Tract Infection, Pediatric, Pediatric Acute Respiratory Failure
- What is being tested?
- thermochromic card and distraction card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child must be between 4-6 years old,
- The child must be receiving inhaler treatment,
- The child must not have received IV or IM intervention before inhaler treatment,
- The child's oxygen saturation must be 95% or higher,
- The child's cognitive level and motor development must be appropriate for their age,
- The child and parents must be willing to participate in the study,
- The child and parents must be able to speak Turkish.
Who cannot join
- The child must have a cognitive or mental problem,
- The child must have special needs in terms of hearing, vision and/or speech,
- The child must have a life-threatening condition,
- The child's oxygen saturation level must be below 95%,
- The child must not be routinely receiving inhaler treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
THE EFFECT OF USİNG DİSTRACTOR CARDS AND THERMOCHROMİC CARDS ON PAİN, FEAR, ANXİETY AND PROCEDURE TİME İN CHİLDREN RECEİVİNG INHALER THERAPY.
Respiratory illnesses in children are a leading cause of childhood morbidity and mortality worldwide. Organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) report that millions of children are hospitalized each year due to respiratory illnesses (He, Wang, \& Zhang, 2025). A large proportion of these illnesses are caused by viral agents, and pathogens such as Respiratory Syncytial Virus (RSV), influenza, and rhinoviruses pose serious health threats to young children (Chen, Zhang, \& Li, 2024).
Read more
This study will be one of the rare studies in pediatric nursing that examines the effectiveness of non-pharmacological interventions that can be applied during inhaler therapy in young age groups. The findings will contribute to nurses developing effective methods to reduce the negative emotions experienced by children during treatment. Furthermore, the first-ever use of thermochromic cards in this context in pediatric nursing will provide an innovative perspective on pediatric nursing practices.
H0: Thermochromic cards and distraction cards used during inhaler therapy have no effect on pain, fear, anxiety levels, or processing time.
Thermochromic cards used during inhaler therapy:
H1: reduce the child's pain. H2: reduce the child's fear. H3: reduce the child's anxiety level.
H4: shorten the child's processing time. Distraction cards used during inhaler therapy:
H5: reduce the child's pain. H6: reduce the child's fear. H7: reduce the child's anxiety level. H8: shorten the child's processing time.
- Conditions
- Pediatric Acute Upper Respiratory Tract Infection, Pediatric, Pediatric Acute Respiratory Failure
- Being tested
- thermochromic card, distraction card
- Keywords
- pediatrics, nebulizer therapy, thermochromic card, child, distracting card
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermochromic cardOther
Also called Termokromik kart
Distraction with thermochromic card
distraction cardOther
A distraction card is a visual aid used during medical procedures to reduce a child's perception of pain and fear by diverting their focus away from the procedure and towards the card.
| Study group | Role | What they receive |
|---|---|---|
| thermochromic card | Experimental | The thermochromic card aims to distract the child's attention. Receives: Other: thermochromic card |
| distraction card | Experimental | The distraction card aims to divert the child's attention to something else. Receives: Other: distraction card |
| clinic's routine inhaler treatment group | No intervention | the group in which routine inhaler therapy is applied and no additional intervention is required |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ)
Fear level will be assessed using the Child Fear Scale (ÇKÖ), a self-report scale consisting of six facial expressions and scored from 0 to 10 in increments of two points. Higher scores indicate greater levels of fear.
Measured: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy
Pain intensity before, during, and after inhalation therapy assessed by the Wong-Baker FACES Pain Rating Scale
Pain intensity will be measured using the Wong-Baker FACES Pain Rating Scale, which consists of six facial expressions scored from 0 to 10, where higher scores represent greater pain intensity.
Measured: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy
Anxiety level before, during, and after inhalation therapy assessed by the Child Anxiety Scale-State (ÇAS-D)
Anxiety level will be assessed using the Child Anxiety Scale-State (ÇAS-D), a thermometer-shaped self-report scale developed for children aged 4-10 years. Higher marked levels indicate higher state anxiety.
Measured: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy
Secondary outcomes (1)
Duration of inhalation therapy
Procedure duration will be recorded in minutes from the start to the completion of inhalation therapy.
Measured: During inhalation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Upper Respiratory Tract InfectionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammed Ata Nur GEÇER
- Sponsor type
- University, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Responsible party
- Sponsor-investigator, Muhammed Ata Nur GEÇER, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371026
- Sponsor's protocol ID
- E-13022260-300-1436826
- Acronym
- CALM-INH
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Distractor Cards and Thermochromic Cards on Pain, Fear, Anxiety and Procedure Time in Children Receiving Inhaler Therapy
- ClinicalTrials.gov ID
- NCT07371026
- Acronym / sponsor ID
- CALM-INH / E-13022260-300-1436826
- Conditions
- Pediatric Acute Upper Respiratory Tract Infection, Pediatric, Pediatric Acute Respiratory Failure
- Keywords
- pediatrics, nebulizer therapy, thermochromic card, child, distracting card
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Muhammed Ata Nur GEÇERUniversity, hospital or other
- Collaborators
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Jan 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.
THE EFFECT OF USİNG DİSTRACTOR CARDS AND THERMOCHROMİC CARDS ON PAİN, FEAR, ANXİETY AND PROCEDURE TİME İN CHİLDREN RECEİVİNG INHALER THERAPY.
Respiratory illnesses in children are a leading cause of childhood morbidity and mortality worldwide. Organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) report that millions of children are hospitalized each year due to respiratory illnesses (He, Wang, \& Zhang, 2025). A large proportion of these illnesses are caused by viral agents, and pathogens such as Respiratory Syncytial Virus (RSV), influenza, and rhinoviruses pose serious health threats to young children (Chen, Zhang, \& Li, 2024).
This study will be one of the rare studies in pediatric nursing that examines the effectiveness of non-pharmacological interventions that can be applied during inhaler therapy in young age groups. The findings will contribute to nurses developing effective methods to reduce the negative emotions experienced by children during treatment. Furthermore, the first-ever use of thermochromic cards in this context in pediatric nursing will provide an innovative perspective on pediatric nursing practices.
H0: Thermochromic cards and distraction cards used during inhaler therapy have no effect on pain, fear, anxiety levels, or processing time.
Thermochromic cards used during inhaler therapy:
H1: reduce the child's pain. H2: reduce the child's fear. H3: reduce the child's anxiety level.
H4: shorten the child's processing time. Distraction cards used during inhaler therapy:
H5: reduce the child's pain. H6: reduce the child's fear. H7: reduce the child's anxiety level. H8: shorten the child's processing time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| thermochromic card | Experimental | Other: thermochromic cardThe thermochromic card aims to distract the child's attention. |
| distraction card | Experimental | Other: distraction cardThe distraction card aims to divert the child's attention to something else. |
| clinic's routine inhaler treatment group | No intervention | –the group in which routine inhaler therapy is applied and no additional intervention is required |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The child must be between 4-6 years old,
- The child must be receiving inhaler treatment,
- The child must not have received IV or IM intervention before inhaler treatment,
- The child's oxygen saturation must be 95% or higher,
- The child's cognitive level and motor development must be appropriate for their age,
Key exclusion criteria (5 listed)
- The child must have a cognitive or mental problem,
- The child must have special needs in terms of hearing, vision and/or speech,
- The child must have a life-threatening condition,
- The child's oxygen saturation level must be below 95%,
- The child must not be routinely receiving inhaler treatment
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 |
|---|---|---|
| thermochromic cardAlso: Termokromik kartDistraction with thermochromic card | Other | thermochromic card |
| distraction cardA distraction card is a visual aid used during medical procedures to reduce a child's perception of pain and fear by diverting their focus away from the procedure and towards the card. | Other | distraction card |
Primary outcome
Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ)
Time frame: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy
Fear level will be assessed using the Child Fear Scale (ÇKÖ), a self-report scale consisting of six facial expressions and scored from 0 to 10 in increments of two points. Higher scores indicate greater levels of fear.
Pain intensity before, during, and after inhalation therapy assessed by the Wong-Baker FACES Pain Rating Scale
Time frame: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy
Pain intensity will be measured using the Wong-Baker FACES Pain Rating Scale, which consists of six facial expressions scored from 0 to 10, where higher scores represent greater pain intensity.
Anxiety level before, during, and after inhalation therapy assessed by the Child Anxiety Scale-State (ÇAS-D)
Time frame: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy
Anxiety level will be assessed using the Child Anxiety Scale-State (ÇAS-D), a thermometer-shaped self-report scale developed for children aged 4-10 years. Higher marked levels indicate higher state anxiety.
1 secondary outcome
Duration of inhalation therapy
Time frame: During inhalation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing thermochromic card and distraction card in people with Pediatric Acute Upper Respiratory Tract Infection and Pediatric, run by Muhammed Ata Nur GEÇER.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Ata Nur GEÇER, MsC, PhD (Candicate) (+905455258654, mangecer0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ) (time frame: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.