Nebulizer TherapyNCT06668311
Play Dough and Picture Books: Reducing Anxiety and Fear in 3-6-Year-Olds During Nebulizer Treatment
A study testing play dough and picture book reading in people with Nebulizer Therapy, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of play dough and picture books on physiological parameters, anxiety, and fear levels in children aged 3-6 undergoing nebulizer treatment. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Nebulizer Therapy
- What is being tested?
- play dough and picture book reading
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Nov 2025
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being in the 3-6 age group
- Follow-up in the emergency department with upper or lower respiratory tract disease
- Application of nebuliser therapy
- Staying with the parent during the research
- To be able to speak and understand Turkish
- Parents' consent to participate in the study
Who cannot join
- Having a disease that causes maladaptive behaviours (ADHD, Autism, etc.)
- Having a chronic disease affecting the respiratory tract
- Chronic diseases or serious infections affecting vital signs
- Implementation of droplet or contact isolation
- Having a physical disability that will prevent him/her from playing with playdough
- Having a cognitive disability that prevents reading books
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başkent University
Ankara, Beşevler, 60300
İlçim Ercan Koyuncu, RN, MSc, 05534700629, ilcimercan@hotmail.com
Ayşe Ay, Asisst Prof
About this study
Official title: The Impact of Play Dough and Picture Books on Physiological Parameters, Anxiety, and Fear in 3-6-Year-Old Children During Nebulizer Treatment: a Randomized Controlled Study
This randomized controlled trial aims to evaluate the effects of play dough and picture books on physiological parameters, anxiety, and fear levels in children aged 3-6 undergoing nebulizer treatment. The trial will involve two groups: an intervention group engaging with play dough and picture books during treatment and a control group receiving standard care. Physiological data, including heart rate and oxygen saturation, will be monitored alongside behavioral assessments of anxiety and fear. This study seeks to determine whether these non-pharmacological interventions can alleviate distress in young children, contributing to more child-friendly treatment approaches in pediatric healthcare.
- Conditions
- Nebulizer Therapy
- Being tested
- play dough, picture book reading
- Keywords
- nursing care, nubulizer therapy, pediatric emergency department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
play doughOther
- Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained.
- The first part of the Patient Information Form will be completed for children who accept the study.
- The second part of the Patient Information Form will be completed five minutes before nebulizer treatment.
- Five minutes before nebulizer treatment, play dough will be given to the child.
- The child will be allowed to play with the play dough during the nebulizer treatment.
- The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over.
- The application will take approximately 15 minutes.
picture book readingOther
- Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained.
- The first part of the Patient Information Form will be completed for children who accept the study.
- The second part of the Patient Information Form will be completed five minutes before nebulizer treatment.
- Five minutes before nebulizer treatment, the child will be given a picture book.
- Picture book will be read to the child during the treatment.
- The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over.
- The application will take approximately 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Play Dough Group | Experimental | The child will be provided with play dough five minutes before the commencement of nebulizer treatment and will be allowed to continue playing with it throughout the treatment. Receives: Other: play dough |
| Picture Book Reading group | Experimental | Five minutes before the commencement of nebulizer treatment, the child will be provided with a picture book and will be allowed to continue reading it throughout the treatment. Receives: Other: picture book reading |
| Control Group | No intervention | Nebulizer treatment of the child will be performed by the routine protocols currently applied in the emergency department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear
The scale was developed for the age group of 4-10 years and is used in studies up to 3 years of age. It consists of five facial expressions ranging from neutral (0 points: no anxiety) to frightened face (4 points: severe anxiety). The child is asked to mark the degree of fear by choosing the most appropriate facial expression. As the score obtained from the scale increases, the child's level of fear increases.
Measured: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Anxiety
The scale is in the form of a thermometer. The bottom part of the thermometer is labelled as 'Calm: Not tense or anxious (0 points)', and the top part is rated as "Very tense or anxious (10 points)". To assess the child's state of anxiety, the child is asked to mark how he/she feels 'right now' on the thermometer. As the score obtained from the scale increases, the anxiety level of the child increases.
Measured: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Secondary outcomes (3)
Pulse Rate
Maintaining and normalizing pulse rate within normal range (75-115 per minute)
Measured: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Respiratory Rate
Maintaining and normalizing respiratory rate within normal range (20-25 per minute)
Measured: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Saturation rate
Maintaining and normalizing saturation rate within normal range (95-100%)
Measured: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nebulizer TherapyStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilcim Ercan Koyuncu, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668311
- Sponsor's protocol ID
- Nebulizer Treatment
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goralski JL, Davis SD. Breathing easier: addressing the challenges of aerosolizing medications to infants and preschoolers. Respir Med. 2014 Aug;108(8):1069-74. doi: 10.1016/j.rmed.2014.06.004. Epub 2014 Jun 25.
PubMed 25012949Esposito-Festen J, Ijsselstijn H, Hop W, van Vliet F, de Jongste J, Tiddens H. Aerosol therapy by pressured metered-dose inhaler-spacer in sleeping young children: to do or not to do? Chest. 2006 Aug;130(2):487-92. doi: 10.1378/chest.130.2.487.
PubMed 16899849Erzinger S, Schueepp KG, Brooks-Wildhaber J, Devadason SG, Wildhaber JH. Facemasks and aerosol delivery in vivo. J Aerosol Med. 2007;20 Suppl 1:S78-83; discussion S83-4. doi: 10.1089/jam.2007.0572.
PubMed 17411409DiBlasi RM. Clinical Controversies in Aerosol Therapy for Infants and Children. Respir Care. 2015 Jun;60(6):894-914; discussion 914-6. doi: 10.4187/respcare.04137.
PubMed 26070582Supat B, Brennan JJ, Vilke GM, Ishimine P, Hsia RY, Castillo EM. Characterizing pediatric high frequency users of California emergency departments. Am J Emerg Med. 2019 Sep;37(9):1699-1704. doi: 10.1016/j.ajem.2018.12.015. Epub 2018 Dec 12.
PubMed 30651182Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018.
PubMed 33742204
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Play Dough and Picture Books on Physiological Parameters, Anxiety, and Fear in 3-6-Year-Old Children During Nebulizer Treatment: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06668311
- Acronym / sponsor ID
- Nebulizer Treatment
- Conditions
- Nebulizer Therapy
- Keywords
- nursing care, nubulizer therapy, pediatric emergency department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 31 Oct 2024 (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.
This randomized controlled trial aims to evaluate the effects of play dough and picture books on physiological parameters, anxiety, and fear levels in children aged 3-6 undergoing nebulizer treatment. The trial will involve two groups: an intervention group engaging with play dough and picture books during treatment and a control group receiving standard care. Physiological data, including heart rate and oxygen saturation, will be monitored alongside behavioral assessments of anxiety and fear. This study seeks to determine whether these non-pharmacological interventions can alleviate distress in young children, contributing to more child-friendly treatment approaches in pediatric healthcare.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Play Dough Group | Experimental | Other: play doughThe child will be provided with play dough five minutes before the commencement of nebulizer treatment and will be allowed to continue playing with it throughout the treatment. |
| Picture Book Reading group | Experimental | Other: picture book readingFive minutes before the commencement of nebulizer treatment, the child will be provided with a picture book and will be allowed to continue reading it throughout the treatment. |
| Control Group | No intervention | –Nebulizer treatment of the child will be performed by the routine protocols currently applied in the emergency department. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being in the 3-6 age group
- Follow-up in the emergency department with upper or lower respiratory tract disease
- Application of nebuliser therapy
- Staying with the parent during the research
- To be able to speak and understand Turkish
Key exclusion criteria (6 listed)
- Having a disease that causes maladaptive behaviours (ADHD, Autism, etc.)
- Having a chronic disease affecting the respiratory tract
- Chronic diseases or serious infections affecting vital signs
- Implementation of droplet or contact isolation
- Having a physical disability that will prevent him/her from playing with playdough
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 |
|---|---|---|
| play dough1. Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained. 2. The first part of the Patient Information Form will be completed for children who accept the study. 3. The second part of the Patient Information Form will be completed five minutes before nebulizer treatment. 4. Five minutes before nebulizer treatment, play dough will be given to the child. 5. The child will be allowed to play with the play dough during the nebulizer treatment. 6. The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over. 7. The application will take approximately 15 minutes. | Other | Play Dough Group |
| picture book reading1. Children and families will be informed about the purpose of the study and their verbal and written consent will be obtained. 2. The first part of the Patient Information Form will be completed for children who accept the study. 3. The second part of the Patient Information Form will be completed five minutes before nebulizer treatment. 4. Five minutes before nebulizer treatment, the child will be given a picture book. 5. Picture book will be read to the child during the treatment. 6. The second part of the Patient Information Form will be filled in at the 5th minute of the treatment and after the treatment is over. 7. The application will take approximately 15 minutes. | Other | Picture Book Reading group |
Primary outcome
Fear
Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
The scale was developed for the age group of 4-10 years and is used in studies up to 3 years of age. It consists of five facial expressions ranging from neutral (0 points: no anxiety) to frightened face (4 points: severe anxiety). The child is asked to mark the degree of fear by choosing the most appropriate facial expression. As the score obtained from the scale increases, the child's level of fear increases.
Anxiety
Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
The scale is in the form of a thermometer. The bottom part of the thermometer is labelled as 'Calm: Not tense or anxious (0 points)', and the top part is rated as "Very tense or anxious (10 points)". To assess the child's state of anxiety, the child is asked to mark how he/she feels 'right now' on the thermometer. As the score obtained from the scale increases, the anxiety level of the child increases.
3 secondary outcomes
Pulse Rate
Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Respiratory Rate
Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Saturation rate
Time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Background: PubMed 25012949Goralski JL, Davis SD. Breathing easier: addressing the challenges of aerosolizing medications to infants and preschoolers. Respir Med. 2014 Aug;108(8):1069-74. doi: 10.1016/j.rmed.2014.06.004. Epub 2014 Jun 25.
- Background: PubMed 16899849Esposito-Festen J, Ijsselstijn H, Hop W, van Vliet F, de Jongste J, Tiddens H. Aerosol therapy by pressured metered-dose inhaler-spacer in sleeping young children: to do or not to do? Chest. 2006 Aug;130(2):487-92. doi: 10.1378/chest.130.2.487.
- Background: PubMed 17411409Erzinger S, Schueepp KG, Brooks-Wildhaber J, Devadason SG, Wildhaber JH. Facemasks and aerosol delivery in vivo. J Aerosol Med. 2007;20 Suppl 1:S78-83; discussion S83-4. doi: 10.1089/jam.2007.0572.
- Background: PubMed 26070582DiBlasi RM. Clinical Controversies in Aerosol Therapy for Infants and Children. Respir Care. 2015 Jun;60(6):894-914; discussion 914-6. doi: 10.4187/respcare.04137.
- Background: PubMed 30651182Supat B, Brennan JJ, Vilke GM, Ishimine P, Hsia RY, Castillo EM. Characterizing pediatric high frequency users of California emergency departments. Am J Emerg Med. 2019 Sep;37(9):1699-1704. doi: 10.1016/j.ajem.2018.12.015. Epub 2018 Dec 12.
- Background: PubMed 33742204Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing play dough and picture book reading in people with Nebulizer Therapy, run by Baskent 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İlçim Ercan Koyuncu, RN, MSc (+905534700629, ilcimercan@baskent.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear (time frame: 5 minutes before the treatment, at the beginning of treatment, 5th minutes into the treatment, immediately after the treatment). 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 NCT06668311, which also lists 6 linked publications.
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 1 Nov 2024.