Nursing Skills EducationNCT07418697
The Effect of Halsted and Peyton Teaching Approaches on Nursing Students
A study testing Peyton Four-Step Teaching Approach and Halsted Teaching Method in people with Nursing Skills Education, run by Gözde ÖZARAS ÖZ at 1 site in Turkey (Türkiye).
Trial summary
Intramuscular (IM) injection is a fundamental nursing skill that requires accurate anatomical knowledge, correct technique, and safe practice. The ventrogluteal site is currently recommended in clinical guidelines as the safest area for IM injections because it is far from major nerves and blood vessels and allows… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Skills Education
- What is being tested?
- Peyton Four-Step Teaching Approach and Halsted Teaching Method
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2026to 25 Apr 2026
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First-year undergraduate nursing students
- Enrolled in the Fundamentals of Nursing course for the first time
- Have viewed the online instructional videos related to ventrogluteal intramuscular injection before laboratory practice
- Agree to participate voluntarily
- Provide written informed consent
- Attend all scheduled theoretical and laboratory training sessions
Who cannot join
- Graduated from a health vocational high school
- Previously received formal education or training on intramuscular injection techniques
- Do not attend theoretical or laboratory sessions related to the study
- Do not complete the data collection tools
- Withdraw from the study at any stage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cankiri Karatekin University. Faculty of Health Sciences.
Çankırı, Center, 18200
About this study
Official title: The Effect of Halsted and Peyton Teaching Approaches on Nursing Students' Knowledge, Skills, and Self-regulated Learning in Ventrogluteal Injection Administration: A Randomized Controlled Trial.
Intramuscular (IM) injection is a fundamental nursing skill that requires accurate anatomical knowledge, correct technique, and safe practice. The ventrogluteal site is currently recommended in clinical guidelines as the safest area for IM injections because it is far from major nerves and blood vessels and allows effective medication absorption. However, identifying the correct anatomical landmarks and performing the procedure accurately can be challenging for nursing students, particularly during early skills training.
Different teaching approaches are used in nursing education to support the acquisition of psychomotor skills. The traditional Halsted approach ("see one, do one") is widely used because it is time-efficient, but it may not provide sufficient structure for learning complex, multi-step procedures. In contrast, Peyton's four-step teaching approach offers a structured and interactive method that includes demonstration, explanation, learner-guided repetition, and independent performance. This approach is designed to enhance understanding, skill retention, and active participation in the learning process.
Read more
The aim of this randomized controlled trial is to compare the effects of the Halsted teaching approach and Peyton's four-step teaching approach on nursing students' knowledge, skill performance, and self-regulated learning related to ventrogluteal injection administration. The study is conducted with first-year nursing students enrolled in the Fundamentals of Nursing course at a university in Türkiye during the 2025-2026 academic year.
A total of 120 nursing students are randomly assigned to either the intervention group or the control group. All students receive the same theoretical instruction and access to standardized instructional videos before laboratory practice. The control group is taught ventrogluteal injection using the traditional Halsted approach, while the intervention group receives training based on Peyton's four-step teaching method. Skill performance is assessed using an objective structured clinical examination (OSCE) with a standardized skill checklist. Knowledge levels are measured using a validated multiple-choice test, and self-regulated learning is evaluated using a reliable and validated self-regulated learning scale for clinical nursing practice.
The results of this study are expected to provide evidence on whether a structured teaching approach improves learning outcomes in nursing skills education. Findings may contribute to the development of more effective educational strategies for teaching high-risk and technically demanding nursing procedures, ultimately supporting patient safety and clinical competence in future nurses.
Read the detailed description
The acquisition of psychomotor nursing skills is a core component of undergraduate nursing education and plays a critical role in ensuring patient safety and clinical competence. Intramuscular (IM) injection administration is one of the most frequently performed nursing procedures and requires precise anatomical knowledge, correct technique, and adherence to aseptic principles. Among IM injection sites, the ventrogluteal region is recommended by current clinical guidelines as the safest option due to its distance from major nerves and blood vessels, adequate muscle mass, and lower risk of complications. Despite these advantages, ventrogluteal injection is often perceived by nursing students as difficult to learn because it requires accurate identification of anatomical landmarks and coordinated psychomotor performance.
Teaching methods used in nursing skills education may influence how effectively students acquire, retain, and apply complex clinical procedures. The Halsted teaching approach, commonly summarized as "see one, do one," has traditionally been used in skills laboratories because of its simplicity and efficiency. However, this approach may be insufficient for procedures that involve multiple sequential steps and require high levels of cognitive engagement and error awareness. In contrast, Peyton's four-step teaching approach provides a structured framework for skills training that integrates observation, explanation, learner participation, and independent practice. By actively involving students in the learning process, Peyton's approach is thought to enhance deeper understanding, improve psychomotor performance, and support self-regulated learning.
Self-regulated learning is an essential competency for nursing students, particularly in clinical practice settings where learners are expected to plan, monitor, and evaluate their own learning and performance. Educational strategies that promote active participation and structured feedback may contribute to the development of self-regulated learning behaviors. Although previous studies have demonstrated the effectiveness of Peyton's four-step approach in various clinical skills, evidence comparing this approach with the traditional Halsted method specifically for ventrogluteal injection training in nursing education remains limited.
This randomized controlled trial was designed to compare the effects of the Halsted teaching approach and Peyton's four-step teaching approach on nursing students' learning outcomes related to ventrogluteal injection administration. The study focuses on three key domains: cognitive outcomes (knowledge related to ventrogluteal injection), psychomotor outcomes (skill performance assessed through an objective structured clinical examination), and learning process outcomes (self-regulated learning in clinical nursing practice).
The study is conducted in a controlled laboratory setting as part of the Fundamentals of Nursing course. Prior to the laboratory sessions, all participants receive standardized theoretical instruction on intramuscular injections and access to instructional videos prepared by faculty members. This ensures that baseline exposure to theoretical content and visual learning materials is equivalent across groups. Laboratory practice sessions are then conducted using different teaching approaches according to group allocation.
Students assigned to the control group receive ventrogluteal injection training using the traditional Halsted approach. In this method, the instructor demonstrates the procedure, responds to students' questions, and then asks students to perform the skill individually. Feedback is provided during and after practice to correct errors and reinforce correct technique.
Students in the intervention group receive training based on Peyton's four-step teaching approach. This approach includes: (1) demonstration of the procedure without verbal explanation, allowing students to observe the entire skill as a whole; (2) a second demonstration accompanied by detailed verbal explanation of each step; (3) performance of the procedure by the instructor under the verbal guidance of the students, encouraging active cognitive engagement; and (4) independent performance of the procedure by each student. This structured sequence is intended to promote understanding of procedural logic, enhance error recognition, and support skill mastery.
Following the training sessions, learning outcomes are evaluated using standardized and validated measurement tools. Knowledge related to ventrogluteal injection is assessed through pre- and post-tests consisting of multiple-choice questions. Skill performance is evaluated using a structured checklist during an objective structured clinical examination (OSCE). Self-regulated learning is measured using a validated self-regulated learning scale specific to clinical nursing practice. A pilot study was conducted prior to the main study to assess the clarity and feasibility of data collection tools, and pilot data were not included in the final analysis.
Data analysis focuses on comparing changes in knowledge, skill performance, and self-regulated learning between groups. Statistical analyses are performed using appropriate non-parametric methods due to the distribution characteristics of the data. The study is conducted in accordance with ethical principles, and participation is voluntary with informed consent obtained from all students. Participation or non-participation does not influence academic evaluation or course grades.
By comparing a traditional and a structured teaching approach within a controlled educational environment, this study aims to contribute evidence-based insights into effective instructional strategies for nursing skills education. The findings are expected to inform curriculum design and teaching practices, particularly for high-risk and technically demanding procedures such as ventrogluteal injection, and to support the development of competent and self-directed nursing professionals.
- Conditions
- Nursing Skills Education
- Being tested
- Peyton Four-Step Teaching Approach, Halsted Teaching Method
- Keywords
- nursşng education, Ventrogluteal injection, Intramuscular injection, Psychomotor skill training, Peyton four-step approach, Self-regulated learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peyton Four-Step Teaching ApproachBehavioural
A structured educational intervention based on Peyton's four-step teaching approach, including silent demonstration, demonstration with explanation, learner-guided demonstration, and independent performance of ventrogluteal intramuscular injection in a laboratory setting.
Halsted Teaching MethodBehavioural
A traditional educational intervention based on the Halsted teaching method ("see one, do one"), in which students observe the ventrogluteal intramuscular injection procedure and then perform it individually during laboratory practice.
| Study group | Role | What they receive |
|---|---|---|
| Peyton Four-Step Teaching Approach | Experimental | Participants in this arm receive training in ventrogluteal intramuscular injection using Peyton's four-step teaching approach, including demonstration, explanation, learner-guided demonstration, and independent performance during laboratory practice. Receives: Behavioral: Peyton Four-Step Teaching Approach |
| Halsted Teaching Method | Active comparator | Participants in this arm receive training in ventrogluteal intramuscular injection using the traditional Halsted teaching method ("see one, do one") during laboratory practice. Receives: Behavioral: Halsted Teaching Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventrogluteal Injection Skill Performance
Skill performance in ventrogluteal intramuscular injection administration is assessed using a structured Ventrogluteal Injection Skill Checklist during an Objective Structured Clinical Examination (OSCE). The checklist consists of 33 items evaluating correct performance of each procedural step. Each item is scored as 0 (incorrect/not performed) or 1 (correct), and total scores are converted to a 0-100 scale. Higher scores indicate better skill performance.
Measured: Immediately after completion of the laboratory training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start25 Feb 2026
- Primary completion25 Mar 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing Skills EducationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group randomized controlled design. Eligible nursing students are randomly assigned to either an intervention group receiving training based on Peyton's four-step teaching approach or a control group receiving training based on the traditional Halsted teaching method. Both groups receive the same theoretical instruction prior to laboratory practice, and outcomes are assessed after the intervention.
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gözde ÖZARAS ÖZ
- Sponsor type
- University, hospital or other
- Collaborators
- Çankırı Karatekin University
- Responsible party
- Sponsor-investigator, Gözde ÖZARAS ÖZ, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418697
- Sponsor's protocol ID
- ARCS-ER-MED-2026-A
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is an educational intervention conducted with undergraduate nursing students. Individual participant data will not be shared because the data consist of educational assessments, skill performance scores, and self-reported learning measures collected within an institutional training context. Data sharing was not included in the informed consent process, and sharing individual-level data could compromise participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Halsted and Peyton Teaching Approaches on Nursing Students' Knowledge, Skills, and Self-regulated Learning in Ventrogluteal Injection Administration: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07418697
- Acronym / sponsor ID
- ARCS-ER-MED-2026-A
- Conditions
- Nursing Skills Education
- Keywords
- nursşng education, Ventrogluteal injection, Intramuscular injection, Psychomotor skill training, Peyton four-step approach, Self-regulated learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Gözde ÖZARAS ÖZUniversity, hospital or other
- Collaborators
- Çankırı Karatekin University
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 18 Feb 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.
Intramuscular (IM) injection is a fundamental nursing skill that requires accurate anatomical knowledge, correct technique, and safe practice. The ventrogluteal site is currently recommended in clinical guidelines as the safest area for IM injections because it is far from major nerves and blood vessels and allows effective medication absorption. However, identifying the correct anatomical landmarks and performing the procedure accurately can be challenging for nursing students, particularly during early skills training.
Different teaching approaches are used in nursing education to support the acquisition of psychomotor skills. The traditional Halsted approach ("see one, do one") is widely used because it is time-efficient, but it may not provide sufficient structure for learning complex, multi-step procedures. In contrast, Peyton's four-step teaching approach offers a structured and interactive method that includes demonstration, explanation, learner-guided repetition, and independent performance. This approach is designed to enhance understanding, skill retention, and active participation in the learning process.
The aim of this randomized controlled trial is to compare the effects of the Halsted teaching approach and Peyton's four-step teaching approach on nursing students' knowledge, skill performance, and self-regulated learning related to ventrogluteal injection administration. The study is conducted with first-year nursing students enrolled in the Fundamentals of Nursing course at a university in Türkiye during the 2025-2026 academic year.
A total of 120 nursing students are randomly assigned to either the intervention group or the control group. All students receive the same theoretical instruction and access to standardized instructional videos before laboratory practice. The control group is taught ventrogluteal injection using the traditional Halsted approach, while the intervention group receives training based on Peyton's four-step teaching method. Skill performance is assessed using an objective structured clinical examination (OSCE) with a standardized skill checklist. Knowledge levels are measured using a validated multiple-choice test, and self-regulated learning is evaluated using a reliable and validated self-regulated learning scale for clinical nursing practice.
The results of this study are expected to provide evidence on whether a structured teaching approach improves learning outcomes in nursing skills education. Findings may contribute to the development of more effective educational strategies for teaching high-risk and technically demanding nursing procedures, ultimately supporting patient safety and clinical competence in future nurses.
Detailed description
The acquisition of psychomotor nursing skills is a core component of undergraduate nursing education and plays a critical role in ensuring patient safety and clinical competence. Intramuscular (IM) injection administration is one of the most frequently performed nursing procedures and requires precise anatomical knowledge, correct technique, and adherence to aseptic principles. Among IM injection sites, the ventrogluteal region is recommended by current clinical guidelines as the safest option due to its distance from major nerves and blood vessels, adequate muscle mass, and lower risk of complications. Despite these advantages, ventrogluteal injection is often perceived by nursing students as difficult to learn because it requires accurate identification of anatomical landmarks and coordinated psychomotor performance.
Teaching methods used in nursing skills education may influence how effectively students acquire, retain, and apply complex clinical procedures. The Halsted teaching approach, commonly summarized as "see one, do one," has traditionally been used in skills laboratories because of its simplicity and efficiency. However, this approach may be insufficient for procedures that involve multiple sequential steps and require high levels of cognitive engagement and error awareness. In contrast, Peyton's four-step teaching approach provides a structured framework for skills training that integrates observation, explanation, learner participation, and independent practice. By actively involving students in the learning process, Peyton's approach is thought to enhance deeper understanding, improve psychomotor performance, and support self-regulated learning.
Self-regulated learning is an essential competency for nursing students, particularly in clinical practice settings where learners are expected to plan, monitor, and evaluate their own learning and performance. Educational strategies that promote active participation and structured feedback may contribute to the development of self-regulated learning behaviors. Although previous studies have demonstrated the effectiveness of Peyton's four-step approach in various clinical skills, evidence comparing this approach with the traditional Halsted method specifically for ventrogluteal injection training in nursing education remains limited.
This randomized controlled trial was designed to compare the effects of the Halsted teaching approach and Peyton's four-step teaching approach on nursing students' learning outcomes related to ventrogluteal injection administration. The study focuses on three key domains: cognitive outcomes (knowledge related to ventrogluteal injection), psychomotor outcomes (skill performance assessed through an objective structured clinical examination), and learning process outcomes (self-regulated learning in clinical nursing practice).
The study is conducted in a controlled laboratory setting as part of the Fundamentals of Nursing course. Prior to the laboratory sessions, all participants receive standardized theoretical instruction on intramuscular injections and access to instructional videos prepared by faculty members. This ensures that baseline exposure to theoretical content and visual learning materials is equivalent across groups. Laboratory practice sessions are then conducted using different teaching approaches according to group allocation.
Students assigned to the control group receive ventrogluteal injection training using the traditional Halsted approach. In this method, the instructor demonstrates the procedure, responds to students' questions, and then asks students to perform the skill individually. Feedback is provided during and after practice to correct errors and reinforce correct technique.
Students in the intervention group receive training based on Peyton's four-step teaching approach. This approach includes: (1) demonstration of the procedure without verbal explanation, allowing students to observe the entire skill as a whole; (2) a second demonstration accompanied by detailed verbal explanation of each step; (3) performance of the procedure by the instructor under the verbal guidance of the students, encouraging active cognitive engagement; and (4) independent performance of the procedure by each student. This structured sequence is intended to promote understanding of procedural logic, enhance error recognition, and support skill mastery.
Following the training sessions, learning outcomes are evaluated using standardized and validated measurement tools. Knowledge related to ventrogluteal injection is assessed through pre- and post-tests consisting of multiple-choice questions. Skill performance is evaluated using a structured checklist during an objective structured clinical examination (OSCE). Self-regulated learning is measured using a validated self-regulated learning scale specific to clinical nursing practice. A pilot study was conducted prior to the main study to assess the clarity and feasibility of data collection tools, and pilot data were not included in the final analysis.
Data analysis focuses on comparing changes in knowledge, skill performance, and self-regulated learning between groups. Statistical analyses are performed using appropriate non-parametric methods due to the distribution characteristics of the data. The study is conducted in accordance with ethical principles, and participation is voluntary with informed consent obtained from all students. Participation or non-participation does not influence academic evaluation or course grades.
By comparing a traditional and a structured teaching approach within a controlled educational environment, this study aims to contribute evidence-based insights into effective instructional strategies for nursing skills education. The findings are expected to inform curriculum design and teaching practices, particularly for high-risk and technically demanding procedures such as ventrogluteal injection, and to support the development of competent and self-directed nursing professionals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel-group randomized controlled design. Eligible nursing students are randomly assigned to either an intervention group receiving training based on Peyton's four-step teaching approach or a control group receiving training based on the traditional Halsted teaching method. Both groups receive the same theoretical instruction prior to laboratory practice, and outcomes are assessed after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Peyton Four-Step Teaching Approach | Experimental | Behavioral: Peyton Four-Step Teaching ApproachParticipants in this arm receive training in ventrogluteal intramuscular injection using Peyton's four-step teaching approach, including demonstration, explanation, learner-guided demonstration, and independent performance during laboratory practice. |
| Halsted Teaching Method | Active comparator | Behavioral: Halsted Teaching MethodParticipants in this arm receive training in ventrogluteal intramuscular injection using the traditional Halsted teaching method ("see one, do one") during laboratory practice. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- First-year undergraduate nursing students
- Enrolled in the Fundamentals of Nursing course for the first time
- Have viewed the online instructional videos related to ventrogluteal intramuscular injection before laboratory practice
- Agree to participate voluntarily
- Provide written informed consent
Key exclusion criteria (5 listed)
- Graduated from a health vocational high school
- Previously received formal education or training on intramuscular injection techniques
- Do not attend theoretical or laboratory sessions related to the study
- Do not complete the data collection tools
- Withdraw from the study at any stage
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 |
|---|---|---|
| Peyton Four-Step Teaching ApproachA structured educational intervention based on Peyton's four-step teaching approach, including silent demonstration, demonstration with explanation, learner-guided demonstration, and independent performance of ventrogluteal intramuscular injection in a laboratory setting. | Behavioural | Peyton Four-Step Teaching Approach |
| Halsted Teaching MethodA traditional educational intervention based on the Halsted teaching method ("see one, do one"), in which students observe the ventrogluteal intramuscular injection procedure and then perform it individually during laboratory practice. | Behavioural | Halsted Teaching Method |
Primary outcome
Ventrogluteal Injection Skill Performance
Time frame: Immediately after completion of the laboratory training session
Skill performance in ventrogluteal intramuscular injection administration is assessed using a structured Ventrogluteal Injection Skill Checklist during an Objective Structured Clinical Examination (OSCE). The checklist consists of 33 items evaluating correct performance of each procedural step. Each item is scored as 0 (incorrect/not performed) or 1 (correct), and total scores are converted to a 0-100 scale. Higher scores indicate better skill performance.
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 28 Aug 2026.
- Individual participant dataSharing planned: No. This study is an educational intervention conducted with undergraduate nursing students. Individual participant data will not be shared because the data consist of educational assessments, skill performance scores, and self-reported learning measures collected within an institutional training context. Data sharing was not included in the informed consent process, and sharing individual-level data could compromise participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peyton Four-Step Teaching Approach and Halsted Teaching Method in people with Nursing Skills Education, run by Gözde ÖZARAS ÖZ 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 5 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 28 Aug 2026. 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?
Ventrogluteal Injection Skill Performance (time frame: Immediately after completion of the laboratory training session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.