First Aid TrainingNCT07798102
Effect of Simulation-Based First Aid and Basic Health Training on Parents of Children With Special Need
A study testing 5E Model-Based Simulation Training Group and Standard Training Group in people with First Aid Training and Health Education, run by Ankara Yildirim Beyazıt University.
Trial summary
Childhood accidents and sudden health emergencies are significant public health concerns that may lead to severe injury or death. Parents, as primary caregivers, play a critical role in providing timely first aid and basic health interventions; however, studies indicate that their knowledge and practical skills are… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- First Aid Training, Health Education
- What is being tested?
- 5E Model-Based Simulation Training Group and Standard Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jan 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older Being a parent of a child with special needs Living with the child with special needs Being able to read and write in Turkish Not being a healthcare professional providing care to the child Having no previous first aid training
Who cannot join
- Having a visual or speech impairment Not living with the child with special needs
- Withdrawal Criteria:
- Voluntary withdrawal from the study Failure to attend the required training sessions during the five-week training program Failure to participate in the post-training assessment
About this study
Official title: Effect of Simulation-Based First Aid and Basic Health Training Grounded in the 5E Model on Knowledge and Skills of Parents of Children With Special Needs: This Workshop Brings Life!
Childhood accidents and sudden health emergencies are significant public health concerns that may lead to severe injury or death. Parents, as primary caregivers, play a critical role in providing timely first aid and basic health interventions; however, studies indicate that their knowledge and practical skills are often limited, particularly among families of children with special needs. Therefore, structured training programs are essential. This study aims to evaluate the effect of 5E (Engage, Explore, Explain, Elaborate, and Evaluate)model-based simulation training in first aid and basic health on the knowledge and practical skills of parents of children with special needs. By integrating active learning, hands-on workshops, and interactive teaching methods, the program seeks to enhance theoretical knowledge and practical competence, ultimately supporting safer and more effective responses to pediatric emergencies.
- Conditions
- First Aid Training, Health Education
- Being tested
- 5E Model-Based Simulation Training Group, Standard Training Group
- Keywords
- Interactive training; Simulation-based learning, Disabled Children, health education
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5E Model-Based Simulation Training GroupOther
Participants in the 5E Model-Based Simulation Training Group will receive a comprehensive five-week training program based on the 5E instructional model, including theoretical instruction, mannequin-based practice, and simulation-based scenarios. The simulation-based activities will cover common pediatric emergencies such as airway obstruction, loss of consciousness, bleeding, dehydration, psychological first aid, and basic life support
Standard Training GroupOther
Participants in the Standard Training Group will receive a five-week training program with the same duration and educational content as the 5E Model-Based Simulation Training Group, including theoretical instruction and mannequin-based practice, but without simulation-based scenarios. This design will allow the assessment of the added effect of 5E model-based simulation training on training effectiveness.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Participants in the Control Group will not receive any theoretical instruction, practice, or simulation-based training during the study period and will be observed as a no-intervention control group. |
| 5E Model-Based Simulation Training Group | Experimental | Participants in the 5E Model-Based Simulation Training Group will receive a comprehensive five-week training program including theoretical instruction, mannequin-based practice, and simulation-based scenarios. The simulation-based activities will cover common pediatric emergencies such as airway obstruction, loss of consciousness, bleeding, dehydration, psychological first aid, and basic life support. Receives: Other: 5E Model-Based Simulation Training Group |
| Standard Training Group | Experimental | Participants in the Standard Training Group will receive a five-week training program with the same duration and educational content as the 5E Model-Based Simulation Training Group, including theoretical instruction and mannequin-based practice, but without simulation-based scenarios. This design will allow the assessment of the added effect of 5E model-based simulation training on training effectiveness. Receives: Other: Standard Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent and Child Descriptive Information Form,
The Parent and Child Descriptive Information Form is a 10-item form used to collect demographic and background information about the parents and their children with special needs. The form includes questions regarding the participant's age, sex, education level, marital status, employment status, economic status, duration of providing care to the child with special needs, previous participation in similar training programs, and the age and sex of the child receiving care.
Measured: Pre-training assessment(to)=Before the first training session (November 6, 2026)
First Aid Knowledge Assessment Form:
The First Aid Knowledge Assessment Form is a 30-item instrument used to assess parents' knowledge of first aid. It evaluates knowledge related to general first aid, basic life support, foreign body airway obstruction, injuries, bleeding and shock, disorders of consciousness, burns, heatstroke and frostbite, fractures, dislocations and sprains, and poisoning. Each item is answered as "Yes," "No," or "I don't know." Correct responses are scored as 1 point, whereas incorrect or "I don't know" responses are scored as 0 points. Total scores range from 0 to 30.
Measured: Pre-training assessment(t0) and Post-training assessment(t1)=Before the first training session (November 6, 2026) and immediately after the fifth training session (December 4, 2026)
Basic Health Education Knowledge Assessment Form:
The Basic Health Education Knowledge Assessment Form is a 14-item instrument developed by the researchers to assess parents' knowledge of topics covered in the basic health education program. The form evaluates knowledge related to pediatric emergencies, nutrition, home health and safety, and psychological first aid. Each item is answered as "Yes," "No," or "I don't know." Correct responses are scored as 1 point, whereas incorrect or "I don't know" responses are scored as 0 points. Total scores range from 0 to 14.
Measured: Pre-training assessment(t0) and Post-training assessment(t1)=Before the first training session (November 6, 2026) and immediately after the fifth training session (December 4, 2026)
First Aid Skills Evaluation Form:
The First Aid Skills Evaluation Form is a 36-item instrument developed by the researchers to assess parents' practical first aid skills. The form evaluates basic first aid, management of airway obstruction, minor bleeding control, and basic life support skills for three age groups: infants (0-1 year), children (1-8 years), and adults. Each skill is rated on a 0-2 scale, with 0 indicating unable or incorrect performance, 1 indicating partially correct or assisted performance, and 2 indicating fully correct performance. Total scores range from 0 to 72.
Measured: Post-training assessment(t1)=Immediately after the fifth training session (December 4, 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (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 First Aid TrainingStudies 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
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşah Kayserilioğlu, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798102
- Sponsor's protocol ID
- Çankırı Karatekin Üni-2
- Status last verified
- Aug 2026
- First submitted
- 29 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data may be shared upon reasonable request.
Publications
Adeoya, A. A., Egawa, S., Adeoya, A. S., Nagatomi, R.; Improving child nutrition in disasters by developing a modeled disaster preparedness nutrition education curriculum; Frontiers in Public Health; 2023; 11; 1293875. Akyol, C., Çiftçi, D. S.; Çoklu ortam tasarımı destekli yapılandırmacı öğretim etkinliklerinin öğrencilerin akademik başarılarına etkisi; OPUS International Journal of Society Researches; 2020; 16(31); 4077-4096. Al Daccache, M., Abi Zeid, B., Hojeij, L., Baliki, G., Brück, T., Ghattas, H.; Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings; BMC Nutrition; 2024; 10(1); 60. Biyikli, C., Yağci, E.; 5E Öğrenme Modeli'ne göre düzenlenmiş eğitim durumlarının bilimsel süreç becerilerine etkisi; Ege Eğitim Dergisi; 2014; 15(1); 45. Çakıcı, T. M.; 4-6 Yaş grubu çocuğu olan annelerin ev kazalarını önlemeye yönelik önlemlerinin incelenmesi, ev kazaları ve ilkyardım konusundaki bilgi, tutum ve davranışlarına eğitimin etkisi: Bir müdahale çalışması; Tıpta Uzmanlık Tezi, Erciyes Üniversitesi; 2016. Dilmen Bayar, B., Yaşar Can, S.; Mardin il merkezinde toplu taşıma aracı kullanan şoförlerin ilk yardım bilgi ve beceri düzeylerinin araştırılması; Avrasya Sağlık Bilimleri Dergisi; 2020; 3(3); 184-189. Dinçer, İ., Balcı, U. G., Harputluoğlu, N., Anıl, M.; Evaluation of the level of basic first aid knowledge of parents; Journal of Pediatric Emergency and Intensive Care Medicine; 2025; 12(1); 14-21. Eldeniz-Çetin, M.; Özel gereksinimli bireylerin tercihlerinin değerlendirilmesi; Ankara Üniversitesi Eğitim Bilimleri Fakültesi Özel Eğitim Dergisi; 2017; 18(2); 309-328. Freeman, S., Eddy, S. L., McDonough, M., Smith, M. K., Okoroafor, N., Jordt, H., Wenderoth, M. P.; Active learning increases student performance in science, engineering, and mathematics; Proceedings of the National Academy of Sciences; 2014; 111(23); 8410-8415. García-Blaya, J. Á., Abraldes, J. A., Vaquero-Cristóbal, R.; As
Garcia-Blaya JA, Abraldes JA, Vaquero-Cristobal R. Assessment of First Aid Knowledge at Different Stages of Education. Healthcare (Basel). 2025 Jun 24;13(13):1507. doi: 10.3390/healthcare13131507.
PubMed 40648532Freeman S, Eddy SL, McDonough M, Smith MK, Okoroafor N, Jordt H, Wenderoth MP. Active learning increases student performance in science, engineering, and mathematics. Proc Natl Acad Sci U S A. 2014 Jun 10;111(23):8410-5. doi: 10.1073/pnas.1319030111. Epub 2014 May 12.
PubMed 24821756Al Daccache M, Abi Zeid B, Hojeij L, Baliki G, Bruck T, Ghattas H. Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings. BMC Nutr. 2024 Apr 19;10(1):60. doi: 10.1186/s40795-024-00864-8.
PubMed 38641632Akyol, C., Çiftçi, D. S.; Çoklu ortam tasarımı destekli yapılandırmacı öğretim etkinliklerinin öğrencilerin akademik başarılarına etkisi; OPUS International Journal of Society Researches; 2020; 16(31); 4077-4096.
Adeoya AA, Egawa S, Adeoya AS, Nagatomi R. Improving child nutrition in disasters by developing a modeled disaster preparedness nutrition education curriculum. Front Public Health. 2023 Dec 7;11:1293875. doi: 10.3389/fpubh.2023.1293875. eCollection 2023.
PubMed 38131021
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simulation-Based First Aid and Basic Health Training Grounded in the 5E Model on Knowledge and Skills of Parents of Children With Special Needs: This Workshop Brings Life!
- ClinicalTrials.gov ID
- NCT07798102
- Acronym / sponsor ID
- Çankırı Karatekin Üni-2
- Conditions
- First Aid Training, Health Education
- Keywords
- Interactive training; Simulation-based learning, Disabled Children, health education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Sep 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.
Childhood accidents and sudden health emergencies are significant public health concerns that may lead to severe injury or death. Parents, as primary caregivers, play a critical role in providing timely first aid and basic health interventions; however, studies indicate that their knowledge and practical skills are often limited, particularly among families of children with special needs. Therefore, structured training programs are essential. This study aims to evaluate the effect of 5E (Engage, Explore, Explain, Elaborate, and Evaluate)model-based simulation training in first aid and basic health on the knowledge and practical skills of parents of children with special needs. By integrating active learning, hands-on workshops, and interactive teaching methods, the program seeks to enhance theoretical knowledge and practical competence, ultimately supporting safer and more effective responses to pediatric emergencies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Participants in the Control Group will not receive any theoretical instruction, practice, or simulation-based training during the study period and will be observed as a no-intervention control group. |
| 5E Model-Based Simulation Training Group | Experimental | Other: 5E Model-Based Simulation Training GroupParticipants in the 5E Model-Based Simulation Training Group will receive a comprehensive five-week training program including theoretical instruction, mannequin-based practice, and simulation-based scenarios. The simulation-based activities will cover common pediatric emergencies such as airway obstruction, loss of consciousness, bleeding, dehydration, psychological first aid, and basic life support. |
| Standard Training Group | Experimental | Other: Standard Training GroupParticipants in the Standard Training Group will receive a five-week training program with the same duration and educational content as the 5E Model-Based Simulation Training Group, including theoretical instruction and mannequin-based practice, but without simulation-based scenarios. This design will allow the assessment of the added effect of 5E model-based simulation training on training effectiveness. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older Being a parent of a child with special needs Living with the child with special needs Being able to read and write in Turkish Not being a healthcare professional providing care to the child Having no previous first aid training
Key exclusion criteria (3 listed)
- Having a visual or speech impairment Not living with the child with special needs
- Voluntary withdrawal from the study Failure to attend the required training sessions during the five-week training program Failure to participate in the post-training assessment
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 |
|---|---|---|
| 5E Model-Based Simulation Training GroupParticipants in the 5E Model-Based Simulation Training Group will receive a comprehensive five-week training program based on the 5E instructional model, including theoretical instruction, mannequin-based practice, and simulation-based scenarios. The simulation-based activities will cover common pediatric emergencies such as airway obstruction, loss of consciousness, bleeding, dehydration, psychological first aid, and basic life support | Other | 5E Model-Based Simulation Training Group |
| Standard Training GroupParticipants in the Standard Training Group will receive a five-week training program with the same duration and educational content as the 5E Model-Based Simulation Training Group, including theoretical instruction and mannequin-based practice, but without simulation-based scenarios. This design will allow the assessment of the added effect of 5E model-based simulation training on training effectiveness. | Other | Standard Training Group |
Primary outcome
Parent and Child Descriptive Information Form,
Time frame: Pre-training assessment(to)=Before the first training session (November 6, 2026)
The Parent and Child Descriptive Information Form is a 10-item form used to collect demographic and background information about the parents and their children with special needs. The form includes questions regarding the participant's age, sex, education level, marital status, employment status, economic status, duration of providing care to the child with special needs, previous participation in similar training programs, and the age and sex of the child receiving care.
First Aid Knowledge Assessment Form:
Time frame: Pre-training assessment(t0) and Post-training assessment(t1)=Before the first training session (November 6, 2026) and immediately after the fifth training session (December 4, 2026)
The First Aid Knowledge Assessment Form is a 30-item instrument used to assess parents' knowledge of first aid. It evaluates knowledge related to general first aid, basic life support, foreign body airway obstruction, injuries, bleeding and shock, disorders of consciousness, burns, heatstroke and frostbite, fractures, dislocations and sprains, and poisoning. Each item is answered as "Yes," "No," or "I don't know." Correct responses are scored as 1 point, whereas incorrect or "I don't know" responses are scored as 0 points. Total scores range from 0 to 30.
Basic Health Education Knowledge Assessment Form:
Time frame: Pre-training assessment(t0) and Post-training assessment(t1)=Before the first training session (November 6, 2026) and immediately after the fifth training session (December 4, 2026)
The Basic Health Education Knowledge Assessment Form is a 14-item instrument developed by the researchers to assess parents' knowledge of topics covered in the basic health education program. The form evaluates knowledge related to pediatric emergencies, nutrition, home health and safety, and psychological first aid. Each item is answered as "Yes," "No," or "I don't know." Correct responses are scored as 1 point, whereas incorrect or "I don't know" responses are scored as 0 points. Total scores range from 0 to 14.
First Aid Skills Evaluation Form:
Time frame: Post-training assessment(t1)=Immediately after the fifth training session (December 4, 2026)
The First Aid Skills Evaluation Form is a 36-item instrument developed by the researchers to assess parents' practical first aid skills. The form evaluates basic first aid, management of airway obstruction, minor bleeding control, and basic life support skills for three age groups: infants (0-1 year), children (1-8 years), and adults. Each skill is rated on a 0-2 scale, with 0 indicating unable or incorrect performance, 1 indicating partially correct or assisted performance, and 2 indicating fully correct performance. Total scores range from 0 to 72.
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 1 Sep 2026.
- BackgroundAdeoya, A. A., Egawa, S., Adeoya, A. S., Nagatomi, R.; Improving child nutrition in disasters by developing a modeled disaster preparedness nutrition education curriculum; Frontiers in Public Health; 2023; 11; 1293875. Akyol, C., Çiftçi, D. S.; Çoklu ortam tasarımı destekli yapılandırmacı öğretim etkinliklerinin öğrencilerin akademik başarılarına etkisi; OPUS International Journal of Society Researches; 2020; 16(31); 4077-4096. Al Daccache, M., Abi Zeid, B., Hojeij, L., Baliki, G., Brück, T., Ghattas, H.; Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings; BMC Nutrition; 2024; 10(1); 60. Biyikli, C., Yağci, E.; 5E Öğrenme Modeli'ne göre düzenlenmiş eğitim durumlarının bilimsel süreç becerilerine etkisi; Ege Eğitim Dergisi; 2014; 15(1); 45. Çakıcı, T. M.; 4-6 Yaş grubu çocuğu olan annelerin ev kazalarını önlemeye yönelik önlemlerinin incelenmesi, ev kazaları ve ilkyardım konusundaki bilgi, tutum ve davranışlarına eğitimin etkisi: Bir müdahale çalışması; Tıpta Uzmanlık Tezi, Erciyes Üniversitesi; 2016. Dilmen Bayar, B., Yaşar Can, S.; Mardin il merkezinde toplu taşıma aracı kullanan şoförlerin ilk yardım bilgi ve beceri düzeylerinin araştırılması; Avrasya Sağlık Bilimleri Dergisi; 2020; 3(3); 184-189. Dinçer, İ., Balcı, U. G., Harputluoğlu, N., Anıl, M.; Evaluation of the level of basic first aid knowledge of parents; Journal of Pediatric Emergency and Intensive Care Medicine; 2025; 12(1); 14-21. Eldeniz-Çetin, M.; Özel gereksinimli bireylerin tercihlerinin değerlendirilmesi; Ankara Üniversitesi Eğitim Bilimleri Fakültesi Özel Eğitim Dergisi; 2017; 18(2); 309-328. Freeman, S., Eddy, S. L., McDonough, M., Smith, M. K., Okoroafor, N., Jordt, H., Wenderoth, M. P.; Active learning increases student performance in science, engineering, and mathematics; Proceedings of the National Academy of Sciences; 2014; 111(23); 8410-8415. García-Blaya, J. Á., Abraldes, J. A., Vaquero-Cristóbal, R.; As
- Background: PubMed 40648532Garcia-Blaya JA, Abraldes JA, Vaquero-Cristobal R. Assessment of First Aid Knowledge at Different Stages of Education. Healthcare (Basel). 2025 Jun 24;13(13):1507. doi: 10.3390/healthcare13131507.
- Background: PubMed 24821756Freeman S, Eddy SL, McDonough M, Smith MK, Okoroafor N, Jordt H, Wenderoth MP. Active learning increases student performance in science, engineering, and mathematics. Proc Natl Acad Sci U S A. 2014 Jun 10;111(23):8410-5. doi: 10.1073/pnas.1319030111. Epub 2014 May 12.
- Background: PubMed 38641632Al Daccache M, Abi Zeid B, Hojeij L, Baliki G, Bruck T, Ghattas H. Systematic review on the impacts of agricultural interventions on food security and nutrition in complex humanitarian emergency settings. BMC Nutr. 2024 Apr 19;10(1):60. doi: 10.1186/s40795-024-00864-8.
- BackgroundAkyol, C., Çiftçi, D. S.; Çoklu ortam tasarımı destekli yapılandırmacı öğretim etkinliklerinin öğrencilerin akademik başarılarına etkisi; OPUS International Journal of Society Researches; 2020; 16(31); 4077-4096.
- Background: PubMed 38131021Adeoya AA, Egawa S, Adeoya AS, Nagatomi R. Improving child nutrition in disasters by developing a modeled disaster preparedness nutrition education curriculum. Front Public Health. 2023 Dec 7;11:1293875. doi: 10.3389/fpubh.2023.1293875. eCollection 2023.
- Individual participant dataSharing planned: No. Participant data may be shared upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 5E Model-Based Simulation Training Group and Standard Training Group in people with First Aid Training and Health Education, run by Ankara Yildirim Beyazıt University.
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 1 inclusion and 3 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 1 Sep 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?
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?
Parent and Child Descriptive Information Form, (time frame: Pre-training assessment(to)=Before the first training session (November 6, 2026)). The study lists 4 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 NCT07798102, 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 Sep 2026.