Forearm FracturesVR-CASTNCT07683715
Virtual Reality-Assisted Cast Application in Children With Forearm Fractures
A study testing Virtual Reality-Based Educational Animation in people with Forearm Fractures and Procedural Anxiety, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Forearm Fractures, Procedural Anxiety, Doctor-Related Fear
- What is being tested?
- Virtual Reality-Based Educational Animation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 3 Oct 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 15 years.
- Diagnosis of an isolated forearm fracture requiring cast application with traction (greenstick injuries plastic deformation if NOT over 20 degrees bayonet apposition ok if <10 years and growth remains)
- First cast application for the current fracture episode.
- Typically developing children without a known developmental delay or cognitive impairment that would prevent participation in the study assessments.
- Ability of the child to understand age-appropriate instructions and respond to pain, anxiety, and fear-related assessments with caregiver assistance when necessary.
- At least one upper extremity free of immobilization, allowing heart rate assessment during the procedure.
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- Parent or legal guardian able to provide written informed consent.
- Child assent when appropriate according to age and local ethics committee requirements.
- Ability and willingness of the child and caregiver to attend an approximately 30-minute blinded child psychiatry assessment 1 day after cast application.
Who cannot join
- Open forearm fracture.
- Multiple trauma or an additional painful injury that may affect pain, anxiety, or fear assessment.
- Need for emergency surgery, procedural sedation, or general anesthesia during cast application.
- Previous participation in this study.
- Known developmental delay, cognitive impairment, autism spectrum disorder with inability to complete study assessments, or severe psychiatric disorder that may interfere with questionnaire-based evaluation.
- Known epilepsy, photosensitive seizure disorder, severe motion sickness, vestibular disorder, or any condition considered unsafe for VR headset use.
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- Visual or hearing impairment preventing use of the VR intervention or completion of the assessments.
- Head, face, or scalp injury preventing safe or comfortable use of a VR headset.
- Nausea, dizziness, or severe discomfort before the procedure that would prevent VR use.
- Refusal of the child or caregiver to participate.
- Inability to complete the 1-day child psychiatry follow-up assessment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura City Hospital
Istanbul, Istanbul, 34010
About this study
Official title: Does Virtual Reality Reduce Pain, Anxiety, Physiologic Stress, and Return-Visit Fear During Pediatric Forearm Casting? A Randomized Controlled Trial
This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group. In the virtual reality group, children will watch a 3-minute child-friendly animated educational video using a VR headset during cast application. The video explains the casting procedure, how to protect the cast, and what the child should do after the cast is applied.
The study will compare pain, anxiety, heart rate response, caregiver anxiety, and procedure-related fear between the two groups. The casting team will assess the child during the procedure. One day after cast application, each child will undergo an approximately 30-minute evaluation by a child psychiatry clinician who is blinded to group allocation. This follow-up assessment will evaluate the child's current anxiety, anxiety related to the cast experience, fear of returning to the hospital or doctor, and fear-related behaviors after the procedure.
Read the detailed description
Forearm fractures are common injuries in children and frequently require cast immobilization. Although cast application is a routine orthopedic procedure, children may experience pain, anxiety, fear, and physiologic stress during the procedure. In some children, this experience may also lead to fear of returning to the hospital or doctor, sometimes referred to as doctor-related or white coat-related fear.
Virtual reality may help children during medical procedures by providing immersive visual and auditory distraction. In addition, an age-appropriate educational video may reduce uncertainty by explaining what will happen during the procedure and how the child should care for the cast afterward.
This study is designed as a prospective, randomized, parallel-group clinical trial. Children with forearm fractures requiring cast application will be randomized into two groups: a virtual reality group and a standard care group. Children in the virtual reality group will wear a Meta Quest 3 headset during cast application and watch a 3-minute child-friendly animated educational video generated using Google Flow. The video explains the cast application process, cast protection, and post-cast care instructions. Children in the standard care group will undergo routine cast application without virtual reality. Apart from the virtual reality intervention, all clinical care will be the same between the two groups.
During cast application, the orthopedic casting team will record procedural pain, procedural anxiety, heart rate before the procedure, mean heart rate during the procedure, heart rate after a 2-minute recovery period, procedure duration, whether the virtual reality headset was removed, and whether nausea, dizziness, or discomfort occurred. Caregivers will also rate the child's anxiety, their own anxiety, and the child's pain before and after the procedure.
One day after cast application, each child will undergo an approximately 30-minute follow-up assessment by a child psychiatry clinician who is blinded to group allocation. Children and caregivers will be instructed not to disclose whether virtual reality was used. This blinded assessment will evaluate the child's current anxiety, anxiety related to the cast experience, anxiety while returning to the hospital or doctor, reluctance to return to the doctor, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.
The primary objective of the study is to determine whether virtual reality reduces cast-related anxiety and subsequent doctor-related fear after cast application. Secondary objectives include evaluating the effect of virtual reality on procedural pain, procedural anxiety, heart rate response, caregiver anxiety, procedure duration, virtual reality tolerability, and caregiver preference for future use of virtual reality during similar procedures.
- Conditions
- Forearm Fractures, Procedural Anxiety, Doctor-Related Fear
- Being tested
- Virtual Reality-Based Educational Animation, Standard Care
- Keywords
- Virtual Reality, Pediatric Forearm Fracture, Cast Application, Procedural Distress, Educational Animation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Educational AnimationBehavioural
Children assigned to the virtual reality group will watch a 3-minute child-friendly educational animated video through a VR headset during cast application. The video explains the cast application procedure, cast protection, and post-cast care instructions. The intervention is intended to reduce procedural distress through immersive visual and auditory distraction and age-appropriate education.
Standard CareOther
Children assigned to the control group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Assisted Cast Application | Experimental | Children in this group will undergo cast application while watching a 3-minute child-friendly educational animated video through a VR headset. The video explains the cast application procedure, cast protection, and post-cast care instructions. Apart from the VR intervention, routine orthopedic care will be provided. Receives: Behavioral: Virtual Reality-Based Educational Animation |
| Standard Cast Application | Active comparator | Children in this group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day
Cast-related fear and anxiety will be assessed 1 day after cast application by a child psychiatry clinician blinded to group allocation using a structured questionnaire. The assessment will evaluate the child's fear or anxiety related to the cast experience, reluctance to return to the doctor or hospital, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.
Measured: 1 day after cast application
Secondary outcomes (13)
Procedural Anxiety Score During Cast Application
The orthopedic casting team will assess the child's anxiety during cast application using a 0-100 score, where higher scores indicate greater procedural anxiety.
Measured: During cast application
Procedural Pain Score During Cast Application
The orthopedic casting team will assess the child's pain during cast application using a 0-10 score, where higher scores indicate greater procedural pain.
Measured: During cast application
Change in Heart Rate During Cast Application
Heart rate will be recorded before cast application, during the procedure, and after a 2-minute recovery period. Changes in heart rate from baseline to the procedural and recovery periods will be compared between groups.
Measured: Before, during, and 2 minutes after cast application
Procedure Duration
The duration of cast application will be recorded in minutes from the start of the cast application procedure to completion of the procedure. Procedure duration will be compared between the virtual reality group and the standard care group.
Measured: During cast application
Physician-Rated Procedural Difficulty Score
The physician performing the cast application will rate the procedural difficulty using a 0-10 score according to the child's cooperation, movement, crying, fear response, and overall behavioral reaction during cast application. Higher scores indicate greater procedural difficulty.
Measured: During cast application
Child Behavioral Response During Cast Application
The child's behavioral response during cast application will be assessed by the casting physician. The assessment will include cooperation, crying, avoidance behavior, agitation, movement during the procedure, and overall tolerance of the cast application.
Measured: During cast application
Caregiver-Rated Child Anxiety
Caregivers will rate how anxious they think their child is using a 0-100 score, where higher scores indicate greater child anxiety.
Measured: Immediately after cast application
Caregiver Anxiety Score
Caregivers will rate their own anxiety using a 0-100 score, where higher scores indicate greater caregiver anxiety.
Measured: Immediately after cast application
Caregiver-Rated Child Pain Before and After Cast Application
Caregivers will rate the child's pain before and after cast application using a 0-10 score, where higher scores indicate greater pain.
Measured: Before and immediately after cast application
Doctor-Related Fear at Follow-up
Doctor-related fear after the cast experience will be assessed by a blinded child psychiatry clinician using a structured questionnaire. The assessment will include anxiety while returning to the hospital or doctor and reluctance to return to the doctor after the cast experience.
Measured: 1 day after cast application
Post-Procedural Fear-Related Behaviors at Home
Fear-related behaviors at home after cast application will be assessed by the blinded child psychiatry clinician using caregiver and child responses. These behaviors may include fear, crying, sleep disturbance, reluctance to visit the doctor, or other procedure-related distress.
Measured: From cast application to 1-day follow-up
Distress When Remembering the Cast Procedure
The child's distress when remembering the cast application procedure will be assessed by the blinded child psychiatry clinician using a structured questionnaire item. Higher scores or more severe responses indicate greater procedure-related distress.
Measured: 1 day after cast application
Caregiver Preference for Future Virtual Reality Use
Caregivers will be asked whether they would want virtual reality to be used again if a similar procedure is required. Responses will be recorded as yes, no, or undecided.
Measured: Immediately after cast application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Jul 2026
- Primary completion3 Oct 2026
- Study completion3 Oct 2026
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 Forearm FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups: a virtual reality-assisted cast application group and a standard cast application group. Children in the virtual reality group will watch a 3-minute educational animated video using a VR headset during cast application, while children in the control group will receive standard cast application without virtual reality. Outcomes will be compared between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lezgin Mert, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683715
- Sponsor's protocol ID
- 2024KAEK11
- Acronym
- VR-CAST
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request. Shared data will not include names, national identification numbers, contact information, or any directly identifiable personal information. Because the study includes children and child psychiatry assessments, data sharing will be limited to anonymized research data and will require approval by the principal investigator and compliance with applicable ethics committee and institutional regulations.
Publications
Georgiadis AG, Schavee PE, Koester TM, DeBruin WT, Burkitt CC, Truong WH, Laine JC. Virtual Reality as an Adjunct to Pediatric Cast Removal: A Randomized Controlled Trial. JB JS Open Access. 2025 Apr 18;10(2):e24.00244. doi: 10.2106/JBJS.OA.24.00244. eCollection 2025 Apr-Jun.
PubMed 40255492
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Virtual Reality Reduce Pain, Anxiety, Physiologic Stress, and Return-Visit Fear During Pediatric Forearm Casting? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07683715
- Acronym / sponsor ID
- VR-CAST / 2024KAEK11
- Conditions
- Forearm Fractures, Procedural Anxiety, Doctor-Related Fear
- Keywords
- Virtual Reality, Pediatric Forearm Fracture, Cast Application, Procedural Distress, Educational Animation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 3 Oct 2026 (actual)
- Study completion
- 3 Oct 2026 (actual)
- First posted
- 6 Jul 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.
This prospective randomized controlled trial will evaluate whether virtual reality can reduce procedural distress in children undergoing cast application for forearm fractures. Children will be assigned to either a virtual reality group or a standard care group. In the virtual reality group, children will watch a 3-minute child-friendly animated educational video using a VR headset during cast application. The video explains the casting procedure, how to protect the cast, and what the child should do after the cast is applied.
The study will compare pain, anxiety, heart rate response, caregiver anxiety, and procedure-related fear between the two groups. The casting team will assess the child during the procedure. One day after cast application, each child will undergo an approximately 30-minute evaluation by a child psychiatry clinician who is blinded to group allocation. This follow-up assessment will evaluate the child's current anxiety, anxiety related to the cast experience, fear of returning to the hospital or doctor, and fear-related behaviors after the procedure.
Detailed description
Forearm fractures are common injuries in children and frequently require cast immobilization. Although cast application is a routine orthopedic procedure, children may experience pain, anxiety, fear, and physiologic stress during the procedure. In some children, this experience may also lead to fear of returning to the hospital or doctor, sometimes referred to as doctor-related or white coat-related fear.
Virtual reality may help children during medical procedures by providing immersive visual and auditory distraction. In addition, an age-appropriate educational video may reduce uncertainty by explaining what will happen during the procedure and how the child should care for the cast afterward.
This study is designed as a prospective, randomized, parallel-group clinical trial. Children with forearm fractures requiring cast application will be randomized into two groups: a virtual reality group and a standard care group. Children in the virtual reality group will wear a Meta Quest 3 headset during cast application and watch a 3-minute child-friendly animated educational video generated using Google Flow. The video explains the cast application process, cast protection, and post-cast care instructions. Children in the standard care group will undergo routine cast application without virtual reality. Apart from the virtual reality intervention, all clinical care will be the same between the two groups.
During cast application, the orthopedic casting team will record procedural pain, procedural anxiety, heart rate before the procedure, mean heart rate during the procedure, heart rate after a 2-minute recovery period, procedure duration, whether the virtual reality headset was removed, and whether nausea, dizziness, or discomfort occurred. Caregivers will also rate the child's anxiety, their own anxiety, and the child's pain before and after the procedure.
One day after cast application, each child will undergo an approximately 30-minute follow-up assessment by a child psychiatry clinician who is blinded to group allocation. Children and caregivers will be instructed not to disclose whether virtual reality was used. This blinded assessment will evaluate the child's current anxiety, anxiety related to the cast experience, anxiety while returning to the hospital or doctor, reluctance to return to the doctor, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.
The primary objective of the study is to determine whether virtual reality reduces cast-related anxiety and subsequent doctor-related fear after cast application. Secondary objectives include evaluating the effect of virtual reality on procedural pain, procedural anxiety, heart rate response, caregiver anxiety, procedure duration, virtual reality tolerability, and caregiver preference for future use of virtual reality during similar procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: a virtual reality-assisted cast application group and a standard cast application group. Children in the virtual reality group will watch a 3-minute educational animated video using a VR headset during cast application, while children in the control group will receive standard cast application without virtual reality. Outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Assisted Cast Application | Experimental | Behavioral: Virtual Reality-Based Educational AnimationChildren in this group will undergo cast application while watching a 3-minute child-friendly educational animated video through a VR headset. The video explains the cast application procedure, cast protection, and post-cast care instructions. Apart from the VR intervention, routine orthopedic care will be provided. |
| Standard Cast Application | Active comparator | Other: Standard CareChildren in this group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 4 to 15 years.
- Diagnosis of an isolated forearm fracture requiring cast application with traction (greenstick injuries plastic deformation if NOT over 20 degrees bayonet apposition ok if <10 years and growth remains)
- First cast application for the current fracture episode.
- Typically developing children without a known developmental delay or cognitive impairment that would prevent participation in the study assessments.
- Ability of the child to understand age-appropriate instructions and respond to pain, anxiety, and fear-related assessments with caregiver assistance when necessary.
Key exclusion criteria (11 listed)
- Open forearm fracture.
- Multiple trauma or an additional painful injury that may affect pain, anxiety, or fear assessment.
- Need for emergency surgery, procedural sedation, or general anesthesia during cast application.
- Previous participation in this study.
- Known developmental delay, cognitive impairment, autism spectrum disorder with inability to complete study assessments, or severe psychiatric disorder that may interfere with questionnaire-based evaluation.
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 |
|---|---|---|
| Virtual Reality-Based Educational AnimationChildren assigned to the virtual reality group will watch a 3-minute child-friendly educational animated video through a VR headset during cast application. The video explains the cast application procedure, cast protection, and post-cast care instructions. The intervention is intended to reduce procedural distress through immersive visual and auditory distraction and age-appropriate education. | Behavioural | Virtual Reality-Assisted Cast Application |
| Standard CareChildren assigned to the control group will undergo routine cast application without virtual reality. Standard verbal explanation and routine orthopedic care will be provided by the casting team. | Other | Standard Cast Application |
Primary outcome
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day
Time frame: 1 day after cast application
Cast-related fear and anxiety will be assessed 1 day after cast application by a child psychiatry clinician blinded to group allocation using a structured questionnaire. The assessment will evaluate the child's fear or anxiety related to the cast experience, reluctance to return to the doctor or hospital, fear-related behaviors at home such as crying or sleep disturbance, and distress when remembering the cast procedure.
13 secondary outcomes
Procedural Anxiety Score During Cast Application
Time frame: During cast application
Procedural Pain Score During Cast Application
Time frame: During cast application
Change in Heart Rate During Cast Application
Time frame: Before, during, and 2 minutes after cast application
Procedure Duration
Time frame: During cast application
Physician-Rated Procedural Difficulty Score
Time frame: During cast application
Child Behavioral Response During Cast Application
Time frame: During cast application
Caregiver-Rated Child Anxiety
Time frame: Immediately after cast application
Caregiver Anxiety Score
Time frame: Immediately after cast application
Caregiver-Rated Child Pain Before and After Cast Application
Time frame: Before and immediately after cast application
Doctor-Related Fear at Follow-up
Time frame: 1 day after cast application
Post-Procedural Fear-Related Behaviors at Home
Time frame: From cast application to 1-day follow-up
Distress When Remembering the Cast Procedure
Time frame: 1 day after cast application
Caregiver Preference for Future Virtual Reality Use
Time frame: Immediately after cast application
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 13 Oct 2026.
- Background: PubMed 40255492Georgiadis AG, Schavee PE, Koester TM, DeBruin WT, Burkitt CC, Truong WH, Laine JC. Virtual Reality as an Adjunct to Pediatric Cast Removal: A Randomized Controlled Trial. JB JS Open Access. 2025 Apr 18;10(2):e24.00244. doi: 10.2106/JBJS.OA.24.00244. eCollection 2025 Apr-Jun.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request. Shared data will not include names, national identification numbers, contact information, or any directly identifiable personal information. Because the study includes children and child psychiatry assessments, data sharing will be limited to anonymized research data and will require approval by the principal investigator and compliance with applicable ethics committee and institutional regulations.
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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 Virtual Reality-Based Educational Animation in people with Forearm Fractures and Procedural Anxiety, run by Başakşehir Çam & Sakura City Hospital 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 9 inclusion and 11 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 13 Oct 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?
Child Psychiatry-Assessed Cast Experience Anxiety Score at 1 Day (time frame: 1 day after cast application). 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 NCT07683715, 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 13 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.