AnxietyNCT05881941
The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children
A study testing using a soundproof nebulizer with a music and a funny mask added, using a silent nebulizer with no extra attachments and using a routinely employed nebulizer in people with Anxiety and Child, Only, run by Eda SORKUN at 1 site in Turkey (Türkiye).
Trial summary
The goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Child, Only
- What is being tested?
- using a soundproof nebulizer with a music and a funny mask added, using a silent nebulizer with no extra attachments and using a routinely employed nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 8 Aug 2022
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- the child should be between the ages of 3-6,
- will receive inhaler treatment,
- the mother or father should be with the child during the procedure,
- not have used any sedative drugs in the last 8 hours before the application,
- written consent has been obtained from the parents after the procedure,
- the child is not crying before the start
Who cannot join
- the child is younger than 3 years old, older than 6 years oldu,
- the childe has a mental disability,
- communication with the parent havinh a problem (they cannot understand and speak Turkish, etc.),
- the child has pain,
- the child is the terminal period,
- the parent has a situation that prevents the assessment of the scale (mental disability, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine.
Read the detailed description
This is a randomized controlled intervention study. The research was carried out in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital Paediatrics Emergency Service between 1st May 2022 and 1st June 2022. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine. In order to collect data, Descriptive Information Form, State Trait Anxiety Inventory for Parents, Child Fear Scale and Child Emotional Indicators Scale were used. The data obtained in the study were evaluated with the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package program.
- Conditions
- Anxiety, Child, Only
- Being tested
- using a soundproof nebulizer with a music and a funny mask added, using a silent nebulizer with no extra attachments, using a routinely employed nebulizer
- Keywords
- mask, Child, Anxiety, Nebulizer, Atraumatic Care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using a soundproof nebulizer with a music and a funny mask addedDevice
There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer
using a silent nebulizer with no extra attachmentsDevice
There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer
using a routinely employed nebulizerDevice
There were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer
| Study group | Role | What they receive |
|---|---|---|
| using a soundproof nebulizer with a music and a funny mask added | Experimental | Experimental group 1: using a soundproof nebulizer with a music and a funny mask added Receives: Device: using a soundproof nebulizer with a music and a funny mask added |
| using a silent nebulizer with no extra attachments | Experimental | Experimental group 2: using a silent nebulizer with no extra attachments Receives: Device: using a silent nebulizer with no extra attachments |
| using a routinely employed nebulizer | Experimental | Control group: using a routinely employed nebulizer Receives: Device: using a routinely employed nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Wong-Baker Faces Pain Scale
was developed by Donna Wong and Connie Morain Baker (1981) to be used to assess children's pain levels. It was revised in 1983 for assessing pain in children over the age of three (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In this scale, the pain score is determined according to the numerical values given to the various faces (Wong \& Baker, 1988; Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In our study, the researcher filled in the Wong-Baker Faces Pain Scale before the procedure in order to identify the children who were experiencing pain so that they could be excluded from the study. Only children with a pain score of "0" were taken into the study.
Measured: pre-processing
The Children's Emotional Indicators Scale (CIAS)
This scale is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators of children during medical procedures.
Measured: order of operation
The Child Fear Scale (CFS)
was adapted by McMurty et al. (2011) from the Faces Anxiety Scale to measure anxiety in children undergoing painful medical procedures. The Child Fear Scale displays five faces with a range of expressions, from a neutral expression (0 = no anxiety) to a fearful face (4 = serious anxiety) (McMurtry et al., 2011). Permission is not required for the clinical and research usage of CFS. This scale was used in the study to determine the anxiety level of children before and during the procedure
Measured: order of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 May 2022
- Primary completion1 Jun 2022
- Study completion8 Aug 2022
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- . There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eda SORKUN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eda SORKUN, Eskisehir Osmangazi University
- Investigators
- Ayfer Açıkgöz, Principal investigator, aacikgoz@ogu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881941
- Sponsor's protocol ID
- EskisehirOU2643
- Status last verified
- May 2023
- First submitted
- 13 Dec 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Publications
Sorkun E, Acikgoz A, Sahin S. The Effect of Using Soundproof Nebulizers With Music and a Funny Mask Added to Reduce Children's Anxiety in Medical Procedures: A Randomized Controlled Experimental Study. J Eval Clin Pract. 2025 Aug;31(5):e70244. doi: 10.1111/jep.70244.
PubMed 40838433
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sound-Insulated Music Playing and Fıgured Mask Nebulızer Application on the Processing Anxiety of Children
- ClinicalTrials.gov ID
- NCT05881941
- Acronym / sponsor ID
- EskisehirOU2643
- Conditions
- Anxiety, Child, Only
- Keywords
- mask, Child, Anxiety, Nebulizer, Atraumatic Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eda SORKUNUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 31 May 2023 (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 goal of this is a randomized controlled intervention study. The study was carried out to determine the effect of nebulization treatment applied to 3-6-year-old children with a soundproof, music player and figured mask nebulizer on the child's anxiety during the procedure. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine.
Detailed description
This is a randomized controlled intervention study. The research was carried out in Kütahya Health Sciences University Evliya Çelebi Training and Research Hospital Paediatrics Emergency Service between 1st May 2022 and 1st June 2022. The study was completed with 120 children who were admitted to the emergency room and would receive inhalation therapy. There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine. In order to collect data, Descriptive Information Form, State Trait Anxiety Inventory for Parents, Child Fear Scale and Child Emotional Indicators Scale were used. The data obtained in the study were evaluated with the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- . There are 3 groups in the study. These were intervention group 1 using sound-insulated music and nebulizer with figured mask, intervention group 2 using silent nebulizer, and control group using nebulizer used in routine
| Arm | Type | Receives |
|---|---|---|
| using a soundproof nebulizer with a music and a funny mask added | Experimental | Device: using a soundproof nebulizer with a music and a funny mask addedExperimental group 1: using a soundproof nebulizer with a music and a funny mask added |
| using a silent nebulizer with no extra attachments | Experimental | Device: using a silent nebulizer with no extra attachmentsExperimental group 2: using a silent nebulizer with no extra attachments |
| using a routinely employed nebulizer | Experimental | Device: using a routinely employed nebulizerControl group: using a routinely employed nebulizer |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- the child should be between the ages of 3-6,
- will receive inhaler treatment,
- the mother or father should be with the child during the procedure,
- not have used any sedative drugs in the last 8 hours before the application,
- written consent has been obtained from the parents after the procedure,
Key exclusion criteria (6 listed)
- the child is younger than 3 years old, older than 6 years oldu,
- the childe has a mental disability,
- communication with the parent havinh a problem (they cannot understand and speak Turkish, etc.),
- the child has pain,
- the child is the terminal period,
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 |
|---|---|---|
| using a soundproof nebulizer with a music and a funny mask addedThere were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer | Device | using a soundproof nebulizer with a music and a funny mask added |
| using a silent nebulizer with no extra attachmentsThere were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer | Device | using a silent nebulizer with no extra attachments |
| using a routinely employed nebulizerThere were 3 groups in the study. These were Experimental Group 1, using a soundproof nebulizer with a music and a funny mask added, Experimental Group 2 using a silent nebulizer with no extra attachments, and a Control Group using a routinely employed nebulizer | Device | using a routinely employed nebulizer |
Primary outcome
The Wong-Baker Faces Pain Scale
Time frame: pre-processing
was developed by Donna Wong and Connie Morain Baker (1981) to be used to assess children's pain levels. It was revised in 1983 for assessing pain in children over the age of three (Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In this scale, the pain score is determined according to the numerical values given to the various faces (Wong \& Baker, 1988; Wong-Baker Faces Foundation-http://wongbakerfaces.org/). In our study, the researcher filled in the Wong-Baker Faces Pain Scale before the procedure in order to identify the children who were experiencing pain so that they could be excluded from the study. Only children with a pain score of "0" were taken into the study.
The Children's Emotional Indicators Scale (CIAS)
Time frame: order of operation
This scale is an easy-to-evaluate and easy-to-apply scale used to objectively define the emotional indicators of children during medical procedures.
The Child Fear Scale (CFS)
Time frame: order of operation
was adapted by McMurty et al. (2011) from the Faces Anxiety Scale to measure anxiety in children undergoing painful medical procedures. The Child Fear Scale displays five faces with a range of expressions, from a neutral expression (0 = no anxiety) to a fearful face (4 = serious anxiety) (McMurtry et al., 2011). Permission is not required for the clinical and research usage of CFS. This scale was used in the study to determine the anxiety level of children before and during the procedure
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 31 May 2023.
- Derived from this study: PubMed 40838433Sorkun E, Acikgoz A, Sahin S. The Effect of Using Soundproof Nebulizers With Music and a Funny Mask Added to Reduce Children's Anxiety in Medical Procedures: A Randomized Controlled Experimental Study. J Eval Clin Pract. 2025 Aug;31(5):e70244. doi: 10.1111/jep.70244.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Ayfer Açıkgöz principal investigator
aacikgoz@ogu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using a soundproof nebulizer with a music and a funny mask added, using a silent nebulizer with no extra attachments and using a routinely employed nebulizer in people with Anxiety and Child, Only, run by Eda SORKUN 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: finished, as of the sponsor's last update on 31 May 2023. 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?
The Wong-Baker Faces Pain Scale (time frame: pre-processing). 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?
On the ClinicalTrials.gov record for NCT05881941, 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 31 May 2023.