FearNCT06090175
The Effect of Using Projector Kaleidoscope and Matching Card on Children's Fear and Physiological Parameters
A study testing Projector colleyscope group and Matching card group in people with Fear and Child, Only, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned as a randomized controlled experimental type to determine the effect of using a projector caleidoscope and matching card on children's fear and physiological parameters in 3-6-year-old children who were administered inhaler medication. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Fear, Child, Only, Respiratory Disease
- What is being tested?
- Projector colleyscope group and Matching card group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 23 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is between 3-6 years old,
- No communication problems (visual/auditory/mental),
- Oxygen saturation is 90% or above,
- The child does not have a disease that may affect his/her life,
- Parent and child volunteering to participate in the research.
Who cannot join
- Nebul drug administration
- The child has a visual, hearing or mental disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Projector Kaleidoscope and Matching Card on Children's Fear and Physiological Parameters in 3-6 Year Old Children Who Are Administered Inhaler Medication
This research was planned as a randomized controlled experimental type to determine the effect of using a projector caleidoscope and matching card on children's fear and physiological parameters in 3-6-year-old children who were administered inhaler medication.
According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program in line with the literature. While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. The data of the research will be collected using the following data collection tools; Child Information Form and Fear Rating Scale
Read the detailed description
Discovering ways to reduce/eliminate children's anxiety and fear regarding treatment practices will help children experience less fear and stress during these interventions. Examples of methods that can be used include watching cartoons, blowing up balloons, making bubbles, playing videos or games with virtual reality glasses, listening to music, using a caleidoscope, using distraction cards, clown shows, parents trying to divert attention, and playing toys.
Discovering ways to reduce/eliminate children's anxiety and fear regarding treatment practices will help children experience less fear and stress during these interventions.
This research was planned as a randomized controlled experimental type to determine the effect of using a projector collets-cope and matching card on children's fear and physiological parameters in 3-6-year-old children who were administered inhaler medication.
Place and Time the Research Was Conducted The research will be conducted in Tarsus State Hospital pediatric services. Pediatric 1 ward has 16 beds, the pediatric 2 ward has 20 beds, the infant 2 ward has 20 beds, the infant 1 ward has 16 beds and the pediatric surgery ward has 16 beds. Hospitalizations are made due to bronchitis, tonsillitis, measles, pneumonia, otitis, rheumatoid arthritis, nausea, vomiting, diarrhea, high fever, urinary tract infection, appendicitis, circumcision and scabies.
After obtaining written consent from the parent of the child to be treated with inhaler medication, the parent will be explained about the inhaler medication administration and what will be done during the procedure. Then the descriptive information form will be filled out. Children's physiological parameters (pulse, blood pressure, respiration, SPO2) will be measured before and after the procedure. The parent and nurse will evaluate the child's fear score before and after the procedure, which will be recorded in the follow-up form.
Inhaler drug administration is usually applied 3 times at 20-minute intervals in the clinic. While the first inhaler is being administered, the application will be done with the child sitting, choosing a mask suitable for his/her face. The child should be given an average of 10 minutes. After the inhaler medication is given through the mask for a period of time, the fear score will be evaluated simultaneously by the nurse and the parent.
Projector caleidoscope group: Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Before starting the procedure, the child will be introduced to the projector caleidoscope. Before the procedure, this device, which looks like a toy, will be projected onto the wall to divert attention. The projection will continue throughout the inhaler medication administration process. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
Matching card group: Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. The child will be allowed to play with the matching cards 2-3 minutes before starting the drug treatment and will then be encouraged to play throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
Control group: The child was given an average of 10 minutes. Inhaler medication will be provided with a mask that lasts. Nothing will be shown to the child during the application. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, of the Child Fear Scale will be evaluated by the researcher and the parent and recorded by the researcher in the intervention follow-up form.
Data analysis The data obtained within the scope of the research will be evaluated using the Statistical Package For Social Science (SPSS) 26.0 package program. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. Normal distribution assumptions will be taken into account in the application of hypothesis tests.
Pearson chi-square test will be applied to determine whether the dependent variables are normally distributed according to the groups' characteristics. One Way ANOVA test will be used to compare quantitative continuous data between more than two independent groups. Repeated measurements within the group will be evaluated with the Repeated Measures test. The findings will be evaluated at a 95% confidence interval and a 5% significance level.
- Conditions
- Fear, Child, Only, Respiratory Disease
- Being tested
- Projector colleyscope group, Matching card group
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Projector colleyscope groupOther
Projector kaleidoscope will be used in children aged 3-6 who are administered inhaler medication.
Matching card groupOther
Matching card will be used in children aged 3-6 who are administered inhaler medication.
| Study group | Role | What they receive |
|---|---|---|
| projector colleyscope group | Experimental | Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Before starting the procedure, the child will be introduced to the projector colleidoscope. Before the procedure, this device, which looks like a toy, will be projected onto the wall to divert attention. The projection will continue throughout the inhaler medication administration process. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. Receives: Other: Projector colleyscope group |
| Matching card group | Experimental | Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. The child will be allowed to play with the matching cards 2-3 minutes before starting the drug treatment and will then be encouraged to play throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. Receives: Other: Matching card group |
| Control group | No intervention | Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Nothing will be shown to the child during the application. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, the Child Fear Scale will be evaluated by the researcher and the parent and recorded by the researcher in the intervention follow-up form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Information Form
The information form was prepared by scanning the literature on the subject and has 12 questions including the child's age, gender, complaint, parent age (who was with him/her during the application) and educational status, physiological parameters before and after inhaler application.
Measured: 1 day
Children's Fear Scale
It is used to evaluate the anxiety/fear level of children. The scale uses cartoon faces consisting of five pictures and the anxiety/fear level is evaluated with numbers between "0" and "4". The first picture shows a score of "0", that is, "no anxiety/fear is felt", and the last picture shows a score of "4", that is, "the most severe anxiety/fear". As the score increases, the level of anxiety/fear also increases.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Oct 2023
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FearStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Karakul, Tarsus University
- Investigators
- Burcu Korkmaz, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090175
- Sponsor's protocol ID
- 2023/14
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conk, Z. Başbakkal, Z. Yılmaz, H. Bolışık, B. (2013). Pediatri Hemşireliği, Ankara:Akademisyen Tıp Kitabevi.
Durak, H. (2019). Çocuklarda İnhaler İlaç Uygulaması Sırasında Çizgi Film İzletme Ve Oyun Kartı Kullanımının Fizyolojik Parametreler ve Korku Düzeyine Etkisi.(Yüksek Lisans Tezi),(645415).
Erdinç, E. (2022). Evde Nebülizatör Tedavisi Kime? Nasıl?. Toraks Dergisi, 3(2), 21-25. Retrieved from https://turkthoracj.org/content/files/sayilar/93/buyuk/pdf_Toraksder_197.pdf
İnal, S. & Canbulat, N. (2015). Çocuklarda İşlemsel Ağrı Yönetiminde Dikkati Başka Yöne Çekme Yöntemlerinin Kullanımı . Güncel Pediatri , 13 (2) , 116-121
Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.
PubMed 19230769Taşdemir Akkavak, D. & Sarıkaya Karabudak, S. (2019). Hastanede Yatan Okul Çağı Çocukların Hemşireyi ve Hastaneyi Algılama Durumlarının İncelenmesi . Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi , 12 (1) , 46-56
Türk Düdükcü, F. & Taş Arslan, F. (2016). Çocuklarda Nebülizatör İle İlaç Uygulama; Problemler Ve Çözüm Önerileri . Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi , 5 (4) , 71-77 .
Özsamuri, G. (2020) Maske İle İnhaler İlaç Uygulanan 3-6 Yaş Grubu Çocuklarda Müzik Dinletme Ve Çizgi Film İzletmenin Hissedilen Korku, Anksiyete ve Fizyolojik Parametrelere Etkisinin Belirlenmesi.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Projector Kaleidoscope and Matching Card on Children's Fear and Physiological Parameters in 3-6 Year Old Children Who Are Administered Inhaler Medication
- ClinicalTrials.gov ID
- NCT06090175
- Acronym / sponsor ID
- 2023/14
- Conditions
- Fear, Child, Only, Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 19 Oct 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.
This research was planned as a randomized controlled experimental type to determine the effect of using a projector caleidoscope and matching card on children's fear and physiological parameters in 3-6-year-old children who were administered inhaler medication.
According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program in line with the literature. While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. The data of the research will be collected using the following data collection tools; Child Information Form and Fear Rating Scale
Detailed description
Discovering ways to reduce/eliminate children's anxiety and fear regarding treatment practices will help children experience less fear and stress during these interventions. Examples of methods that can be used include watching cartoons, blowing up balloons, making bubbles, playing videos or games with virtual reality glasses, listening to music, using a caleidoscope, using distraction cards, clown shows, parents trying to divert attention, and playing toys.
Discovering ways to reduce/eliminate children's anxiety and fear regarding treatment practices will help children experience less fear and stress during these interventions.
This research was planned as a randomized controlled experimental type to determine the effect of using a projector collets-cope and matching card on children's fear and physiological parameters in 3-6-year-old children who were administered inhaler medication.
Place and Time the Research Was Conducted The research will be conducted in Tarsus State Hospital pediatric services. Pediatric 1 ward has 16 beds, the pediatric 2 ward has 20 beds, the infant 2 ward has 20 beds, the infant 1 ward has 16 beds and the pediatric surgery ward has 16 beds. Hospitalizations are made due to bronchitis, tonsillitis, measles, pneumonia, otitis, rheumatoid arthritis, nausea, vomiting, diarrhea, high fever, urinary tract infection, appendicitis, circumcision and scabies.
After obtaining written consent from the parent of the child to be treated with inhaler medication, the parent will be explained about the inhaler medication administration and what will be done during the procedure. Then the descriptive information form will be filled out. Children's physiological parameters (pulse, blood pressure, respiration, SPO2) will be measured before and after the procedure. The parent and nurse will evaluate the child's fear score before and after the procedure, which will be recorded in the follow-up form.
Inhaler drug administration is usually applied 3 times at 20-minute intervals in the clinic. While the first inhaler is being administered, the application will be done with the child sitting, choosing a mask suitable for his/her face. The child should be given an average of 10 minutes. After the inhaler medication is given through the mask for a period of time, the fear score will be evaluated simultaneously by the nurse and the parent.
Projector caleidoscope group: Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Before starting the procedure, the child will be introduced to the projector caleidoscope. Before the procedure, this device, which looks like a toy, will be projected onto the wall to divert attention. The projection will continue throughout the inhaler medication administration process. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
Matching card group: Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. The child will be allowed to play with the matching cards 2-3 minutes before starting the drug treatment and will then be encouraged to play throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
Control group: The child was given an average of 10 minutes. Inhaler medication will be provided with a mask that lasts. Nothing will be shown to the child during the application. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, of the Child Fear Scale will be evaluated by the researcher and the parent and recorded by the researcher in the intervention follow-up form.
Data analysis The data obtained within the scope of the research will be evaluated using the Statistical Package For Social Science (SPSS) 26.0 package program. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. Normal distribution assumptions will be taken into account in the application of hypothesis tests.
Pearson chi-square test will be applied to determine whether the dependent variables are normally distributed according to the groups' characteristics. One Way ANOVA test will be used to compare quantitative continuous data between more than two independent groups. Repeated measurements within the group will be evaluated with the Repeated Measures test. The findings will be evaluated at a 95% confidence interval and a 5% significance level.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| projector colleyscope group | Experimental | Other: Projector colleyscope groupApproximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Before starting the procedure, the child will be introduced to the projector colleidoscope. Before the procedure, this device, which looks like a toy, will be projected onto the wall to divert attention. The projection will continue throughout the inhaler medication administration process. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. |
| Matching card group | Experimental | Other: Matching card groupApproximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. The child will be allowed to play with the matching cards 2-3 minutes before starting the drug treatment and will then be encouraged to play throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. |
| Control group | No intervention | –Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Nothing will be shown to the child during the application. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, the Child Fear Scale will be evaluated by the researcher and the parent and recorded by the researcher in the intervention follow-up form. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child is between 3-6 years old,
- No communication problems (visual/auditory/mental),
- Oxygen saturation is 90% or above,
- The child does not have a disease that may affect his/her life,
- Parent and child volunteering to participate in the research.
Key exclusion criteria (2 listed)
- Nebul drug administration
- The child has a visual, hearing or mental disability
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 |
|---|---|---|
| Projector colleyscope groupProjector kaleidoscope will be used in children aged 3-6 who are administered inhaler medication. | Other | projector colleyscope group |
| Matching card groupMatching card will be used in children aged 3-6 who are administered inhaler medication. | Other | Matching card group |
Primary outcome
Child Information Form
Time frame: 1 day
The information form was prepared by scanning the literature on the subject and has 12 questions including the child's age, gender, complaint, parent age (who was with him/her during the application) and educational status, physiological parameters before and after inhaler application.
Children's Fear Scale
Time frame: 1 day
It is used to evaluate the anxiety/fear level of children. The scale uses cartoon faces consisting of five pictures and the anxiety/fear level is evaluated with numbers between "0" and "4". The first picture shows a score of "0", that is, "no anxiety/fear is felt", and the last picture shows a score of "4", that is, "the most severe anxiety/fear". As the score increases, the level of anxiety/fear also increases.
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 27 Nov 2023.
- BackgroundConk, Z. Başbakkal, Z. Yılmaz, H. Bolışık, B. (2013). Pediatri Hemşireliği, Ankara:Akademisyen Tıp Kitabevi.
- BackgroundDurak, H. (2019). Çocuklarda İnhaler İlaç Uygulaması Sırasında Çizgi Film İzletme Ve Oyun Kartı Kullanımının Fizyolojik Parametreler ve Korku Düzeyine Etkisi.(Yüksek Lisans Tezi),(645415).
- BackgroundErdinç, E. (2022). Evde Nebülizatör Tedavisi Kime? Nasıl?. Toraks Dergisi, 3(2), 21-25. Retrieved from https://turkthoracj.org/content/files/sayilar/93/buyuk/pdf_Toraksder_197.pdf
- Backgroundİnal, S. & Canbulat, N. (2015). Çocuklarda İşlemsel Ağrı Yönetiminde Dikkati Başka Yöne Çekme Yöntemlerinin Kullanımı . Güncel Pediatri , 13 (2) , 116-121
- Background: PubMed 19230769Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.
- BackgroundTaşdemir Akkavak, D. & Sarıkaya Karabudak, S. (2019). Hastanede Yatan Okul Çağı Çocukların Hemşireyi ve Hastaneyi Algılama Durumlarının İncelenmesi . Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi , 12 (1) , 46-56
- BackgroundTürk Düdükcü, F. & Taş Arslan, F. (2016). Çocuklarda Nebülizatör İle İlaç Uygulama; Problemler Ve Çözüm Önerileri . Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi , 5 (4) , 71-77 .
- BackgroundÖzsamuri, G. (2020) Maske İle İnhaler İlaç Uygulanan 3-6 Yaş Grubu Çocuklarda Müzik Dinletme Ve Çizgi Film İzletmenin Hissedilen Korku, Anksiyete ve Fizyolojik Parametrelere Etkisinin Belirlenmesi.
- 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.
Burcu Korkmaz principal investigator
Tarsus 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 Projector colleyscope group and Matching card group in people with Fear and Child, Only, run by Tarsus 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 5 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 27 Nov 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?
Child Information Form (time frame: 1 day). 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 NCT06090175, which also lists 8 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 27 Nov 2023.