Respiratory DiseaseNCT07082907
Use Of Pet Therapy In Chıldren Receıvıng Nebulızer Treatment
An observational study of Respiratory Disease, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
The use of nebulizers in children is one of the most common noninvasive methods used in respiratory system diseases. This application can cause anxiety and stress in children in hospital environments, especially in emergency departments. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- intervention group
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 Jun 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will be conducted on 3-6 year old children who were admitted to a pediatric emergency unit of a training and research hospital with any respiratory distress and were recommended nebule therapy.
Who may be able to join
None listed.
Who cannot join
- Children under 3 and over 6
- Parents and children who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Training and Research Hospital
Rize, Centre, 53100
About this study
Official title: Effects of Pet Therapy on Anxiety, Pulse Rate and Saturation In Children Between 3 and 6 Years of Age Who Received Nebulizer Treatment in the Emergency Department: A Randomized Controlled Study
The use of nebulizers in children is one of the most common noninvasive methods used in respiratory system diseases. This application can cause anxiety and stress in children in hospital environments, especially in emergency departments. Our aim in this study is to evaluate the effect of pet therapy on anxiety, pulse and saturation in children between the ages of 3-6 who receive nebulizer treatment in units such as emergency departments.
Read the detailed description
With nebulizer drug application, drugs such as bronchodilators, antibiotics, anticholinergics, corticosteroids are delivered directly to the lungs by inhalation. In nebulizer drug applications, the amount of drug, the method of administration, the duration, and the position of the patient are the most important criteria to be followed in order to administer the drug appropriately and effectively. Any disruption in any of these applications negatively affects the treatment process. Stress and anxiety experienced during nebulizer treatment in children can cause undesirable results in vital signs such as pulse. Treatment can therefore cause disruption. Although this application does not cause pain, being in a hospital environment and being an intervention applied by health professionals can cause anxiety in children. In addition, symptoms such as tachycardia are observed in children with some drugs administered via nebulizer. Many animal applications are used in animal-assisted therapies and it is emphasized that the stress of child patients decreases with these methods. In nebulizer drug use, the anxiety experienced by children due to both the mask and drug interactions applied in drug treatment and the changes in vital signs they encounter due to drug interactions have been tried to be supported with changing applications in the literature. However, when we look at the literature, we have not found any studies using pet therapy during nebulizer use.
- Conditions
- Respiratory Disease
- Being tested
- intervention group
- Keywords
- Respiratory disease, therapy animals, nebülizer, child
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupOther
Before using the nebulizer, children were given 2 fish in a bowl accompanied by their parents. The child patient was in the fowler/semifowler position, the movements of the fish were monitored during the nebulization period, and the fish was fed by the child during this process (Communication was provided for at least 5 minutes.)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Control group; Standard application was provided to the children in the control group during the use of nebulizer. Fish in a bowl application was not given. However, in order to prevent bias in the study, children in the control group were also provided contact with fish after all data related to the study were collected. Receives: Other: intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for Assessing Children's Emotional Expression
There was a significant relationship between the child's age and the annual number of nebulizer uses on the CDBDS scale score during Pet therapy application (R=0.547, R2=0.300, p<0.05).
Measured: The treatment period for the sick child in the emergency unit covers an average of 20-30 minutes during which time he/she receives nebulization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur AKBAL DEMİRCİ, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082907
- Sponsor's protocol ID
- RTEU-SBF-YA-01
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this study is considered to be forward-looking, it is considered to be shared for now.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pet Therapy on Anxiety, Pulse Rate and Saturation In Children Between 3 and 6 Years of Age Who Received Nebulizer Treatment in the Emergency Department: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07082907
- Acronym / sponsor ID
- RTEU-SBF-YA-01
- Conditions
- Respiratory Disease
- Keywords
- Respiratory disease, therapy animals, nebülizer, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 24 Jul 2025 (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 use of nebulizers in children is one of the most common noninvasive methods used in respiratory system diseases. This application can cause anxiety and stress in children in hospital environments, especially in emergency departments. Our aim in this study is to evaluate the effect of pet therapy on anxiety, pulse and saturation in children between the ages of 3-6 who receive nebulizer treatment in units such as emergency departments.
Detailed description
With nebulizer drug application, drugs such as bronchodilators, antibiotics, anticholinergics, corticosteroids are delivered directly to the lungs by inhalation. In nebulizer drug applications, the amount of drug, the method of administration, the duration, and the position of the patient are the most important criteria to be followed in order to administer the drug appropriately and effectively. Any disruption in any of these applications negatively affects the treatment process. Stress and anxiety experienced during nebulizer treatment in children can cause undesirable results in vital signs such as pulse. Treatment can therefore cause disruption. Although this application does not cause pain, being in a hospital environment and being an intervention applied by health professionals can cause anxiety in children. In addition, symptoms such as tachycardia are observed in children with some drugs administered via nebulizer. Many animal applications are used in animal-assisted therapies and it is emphasized that the stress of child patients decreases with these methods. In nebulizer drug use, the anxiety experienced by children due to both the mask and drug interactions applied in drug treatment and the changes in vital signs they encounter due to drug interactions have been tried to be supported with changing applications in the literature. However, when we look at the literature, we have not found any studies using pet therapy during nebulizer use.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: intervention groupControl group; Standard application was provided to the children in the control group during the use of nebulizer. Fish in a bowl application was not given. However, in order to prevent bias in the study, children in the control group were also provided contact with fish after all data related to the study were collected. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will be conducted on 3-6 year old children who were admitted to a pediatric emergency unit of a training and research hospital with any respiratory distress and were recommended nebule therapy.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Children under 3 and over 6
- Parents and children who do not agree to participate in the study
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 |
|---|---|---|
| intervention groupBefore using the nebulizer, children were given 2 fish in a bowl accompanied by their parents. The child patient was in the fowler/semifowler position, the movements of the fish were monitored during the nebulization period, and the fish was fed by the child during this process (Communication was provided for at least 5 minutes.) | Other | Control group |
Primary outcome
Scale for Assessing Children's Emotional Expression
Time frame: The treatment period for the sick child in the emergency unit covers an average of 20-30 minutes during which time he/she receives nebulization.
There was a significant relationship between the child's age and the annual number of nebulizer uses on the CDBDS scale score during Pet therapy application (R=0.547, R2=0.300, p<0.05).
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 24 Jul 2025.
- Individual participant dataSharing planned: No. Since this study is considered to be forward-looking, it is considered to be shared for now.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by Recep Tayyip Erdogan 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 0 inclusion and 2 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 24 Jul 2025. 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?
Scale for Assessing Children's Emotional Expression (time frame: The treatment period for the sick child in the emergency unit covers an average of 20-30 minutes during which time he/she receives nebulization.). 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 24 Jul 2025.