Tele-nursingNCT07507721
Tele-Nursing-Supported Mindfetalness: Anxiety and Prenatal Attachment
A study testing Tele-Nursing-Supported Mindfetalness and Mindfetalness Alone in people with Tele-nursing and Fetal Movement, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effects of tele-nursing-supported Mindfetalness method versus Mindfetalness alone method on maternal anxiety and prenatal attachment in pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tele-nursing, Fetal Movement
- What is being tested?
- Tele-Nursing-Supported Mindfetalness and Mindfetalness Alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 1 Apr 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Being at the 28th week of gestation
- Having a singleton pregnancy
- Being primiparous
- Being literate
- Having access to and the ability to use a mobile device and internet connection (personal or via spouse) compatible with the tele-nursing application
- Volunteering to participate in the study and providing informed consent (Araştırmaya katılmaya gönüllü olmak ve bilgilendirilmiş onam vermek)
Who cannot join
- Having a high-risk pregnancy (e.g., preterm labor threat, preeclampsia, gestational diabetes, placenta previa, or cardiac disease).
- Presence of diagnosed fetal health complications (e.g., intrauterine growth restriction [IUGR], fetal anomalies).
- Currently monitoring fetal movements using any other conventional fetal movement counting methods.
- Presence of any communication barriers (e.g., hearing, speech, or language impairments).
- History or current diagnosis of chronic or psychiatric illness.
- Conception through assisted reproductive techniques (ART) (e.g., IVF).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Abant Izzet Baysal University Izzet Baysal Training and Research Hospital
Bolu, 14030
Gülnur Yıldırım, +90 374 253 45 20, gulnur.yildirim@saglik.gov.tr
- Not yet recruiting
Bolu Abant Izzet Baysal University
Bolu, 14030
Büşra Boğa, PhD Student, +90 374 253 45 20 ext. 6124, busra.boga@ibu.edu.tr
Nevin Çıtak Bilgin, Associate Professor, PhD
About this study
Official title: The Effect of Tele-nursing-Supported Mindfetalness Method on Maternal Anxiety and Prenatal Attachment: A Mixed Methods Randomized Controlled Trial
The goal of this clinical trial is to compare the effects of tele-nursing-supported Mindfetalness method versus Mindfetalness alone method on maternal anxiety and prenatal attachment in pregnant women. The main questions it aims to answer are:
- H1: Tele-nursing-supported Mindfetalness method will significantly reduce state anxiety (STAI-S) levels in pregnant women over time compared to Mindfetalness alone method.
- H2: Tele-nursing-supported Mindfetalness method will significantly reduce trait anxiety (STAI-T) levels in pregnant women over time compared to Mindfetalness alone method.
- H3: Tele-nursing-supported Mindfetalness method will significantly increase prenatal attachment (PAI) levels in pregnant women over time compared to Mindfetalness alone method.
Read more
Researches will compare tele-nursing-supported Mindfetalness to Mindfetalness alone to see if tele-nursing support significiantly reduces state and trait anxiety levels and significiantly increases prenatal attachment levels in pregnant women over time.
Participants will;
- Attend a single, face-to-face Mindfetalness training session at the beginning of the study to learn technique and application procedures correctly.
- Practice Mindfetalness method daily for 15 minutes throughout the 8-week study period.
- Complete a daily compliance tracking chart to record their adherence to the Mindfetalness method of their practice.
- Complete the State-Trait Anxiety Inventory (STAI) and the Prenatal Attachment Inventory (PAI) at baseline and during 4th and 8th-week follow-up measurements to track changes over time.
- Conditions
- Tele-nursing, Fetal Movement
- Being tested
- Tele-Nursing-Supported Mindfetalness, Mindfetalness Alone
- Keywords
- maternal anxiety, prenatal attachment, mindfetalness, tele-nursing, randomized controlled trial, mixed methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Nursing-Supported MindfetalnessBehavioural
Also called Tele-nursing-supported Mindfetalness method, Mindfetalness Training for Fetal Movement Awareness
The intervention involves the Mindfetalness method, a subjective practice focused on sensing the quality of fetal movements rather than numerical counting. All participants receive a single, face-to-face training session and are instructed to practice the method for 15 minutes daily throughout the 8-week study period. Adherence is monitored via a daily compliance tracking chart, with photos of the logs submitted to researchers at weeks 4 and 8. Tele-nursing-supported uniquely receives additional tele-nursing support, consisting of weekly motivational SMS reminders and two structured phone consultations (at weeks 2 and 6) to provide professional guidance and emotional support, ensuring the method is applied correctly and addressing participants' concerns.
Mindfetalness AloneBehavioural
Also called Mindfetalness Training for Fetal Movement Awareness
The intervention involves the Mindfetalness method, a subjective practice focused on sensing the quality of fetal movements rather than numerical counting. All participants receive a single, face-to-face training session and are instructed to practice the method for 15 minutes daily throughout the 8-week study period. Adherence is monitored via a daily compliance tracking chart, with photos of the logs submitted to researchers at weeks 4 and 8.
| Study group | Role | What they receive |
|---|---|---|
| Mindfetalness Alone | Active comparator | Participants in this group will:
* Complete the baseline assessments (pre-test) prior to the intervention.
* Receive a standardized training session on the Mindfetalness method.
* Be provided with a compliance tracking chart to monitor their daily practice.
* Perform the Mindfetalness application daily for 15 minutes throughout the intervention period.
* Submit photographs of their compliance tracking charts to the researchers at week 4 and week 8 to document to the method.
* Undergo follow-up measurements at week 4 and week 8 to evaluate the ongoing effects of the intervention.
* Following the completion of the research, participants who volunteered for the qualitative phase will be identified, and randomly selected individuals from this volunteer pool will be invited to participate in the interviews to ensure diverse perspectives. Receives: Behavioral: Mindfetalness Alone |
| Tele-Nursing-Supported Mindfetalness | Active comparator | Participants in this group will:
* Complete the baseline assessments prior to the intervention.
* Receive a standardized training session on the Mindfetalness method.
* Be provided with a compliance tracking chart to monitor their daily practice.
* Perform the Mindfetalness application daily for 15 minutes throughout the intervention period.
* Receive weekly SMS reminders throughout the study to encourage consistent practice and maintain motivation for the Mindfetalness method.
* Participate in tele-nursing consultation calls during the 2nd and 6th weeks of the intervention to receive guidance, address concerns, and obtain emotional support regarding the method.
* Submit photographs of their compliance tracking charts to the researchers at week 4 and week 8 to document to the method.
* Undergo follow-up measurements at week 4 and 8 to evaluate the ongoing effects of the intervention.
* Post-intervention, random interviews will be conducted with volunteer participants to gain deeper insights. Receives: Behavioral: Tele-Nursing-Supported Mindfetalness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal state anxiety (State-Trait Anxiety Inventory)
It will be used to assess maternal state anxiety levels. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). The total score ranges from 20 to 80, with higher scores indicating higher levels of state anxiety. In the Turkish adaptation of the scale, the Cronbach's alpha reliability coefficient was reported as 0.94.
Measured: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.
Maternal Trait Anxiety (State-Trait Anxiety Inventory)
It will be used to assess maternal trait anxiety levels. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). The total score ranges from 20 to 80, with higher scores indicating higher levels of trait anxiety. In the Turkish adaptation of the scale, the Cronbach's alpha reliability coefficient was reported as 0.83.
Measured: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.
Prenatal Attachment (Prenatal Attachment Inventory)
It will be used to assess the level of attachment between pregnant women and their babies. The inventory is a four-point Likert-type scale, with each item scored on a scale of 1 to 4, and consists of a total of 21 items. The total score ranges from 21 to 84, with higher scores indicating higher levels of prenatal attachment. The Crohnbach's alpha consistent for the Turkish version of the scale is 0.84.
Measured: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.
Secondary outcomes (3)
Adherence to the Mindfetalness method (Daily Adherence Log)
To ensure protocol fidelity and correct application, a researcher-developed adherence log was utilized, featuring detailed Mindfetalness guidelines on the reverse side. The log includes designated fields for recording the date and time of each session, along with checkboxes for 28 consecutive days of practice. Following the initial training, participants are provided with two copies of the log.
Measured: To verify adherence, participants are required to submit photographs of the completed forms via a secure messaging platform (WhatsApp) at the end of week 4 (first form) and week 8 (second form).
Healthcare Utilization for Perceived Reduced Fetal Movement
This outcome measures the frequency of hospital or outpatient clinic applications made by participants due to a perceived decrease in fetal activity, where subsequent clinical evaluations (e.g., Non-Stress Test or ultrasonography) confirmed normal fetal health (fetal well-being). Data will be collected via self-report questions integrated into the online follow-up forms.
Measured: Hospital admissions will be recorded and evaluated at the end of weeks 4 and 8.
The subjective effects, experiences and satisfaction levels of the intervention among pregnant women (Semi-structured interview form)
The questionnaire developed by the researchers will include five open-ended questions asking pregnant women about their subjective perceptions, experiences and satisfaction regarding the research process and the Mindfetalness method. Some of the questions have been supplemented with follow-up questions.
Measured: Qualitative data will be collected at the end of week 8, following the completion of the 8-week intervention and final quantitative assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start15 Apr 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tele-nursingStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- The study design is a prospective, two-arm (two experimental groups), parallel-group, double-blind, individual-randomised, and embedded mixed-methods clinical trial. This trial will be reported following the CONSORT, COREQ and GRAMMS statement. While quantitative data for the study are being collected, qualitative data will be collected from participants who have completed the research process (participants in the eighth week of the intervention).To capture the subjective depth of the Mindfetalness experience, qualitative interviews were integrated to enrich the quantitative findings on maternal anxiety and prenatal attachment. This mixed-methods approach provides a holistic understanding of the intervention's impact from the participants' perspective.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Boğa, Abant Izzet Baysal University
- Investigators
- Nevin ÇITAK BİLGİN, Associate Professor, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507721
- Sponsor's protocol ID
- AIBU-HEM-BB-03
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the confidentiality and privacy of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tele-nursing-Supported Mindfetalness Method on Maternal Anxiety and Prenatal Attachment: A Mixed Methods Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07507721
- Acronym / sponsor ID
- AIBU-HEM-BB-03
- Conditions
- Tele-nursing, Fetal Movement
- Keywords
- maternal anxiety, prenatal attachment, mindfetalness, tele-nursing, randomized controlled trial, mixed methods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 2 Apr 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.
The goal of this clinical trial is to compare the effects of tele-nursing-supported Mindfetalness method versus Mindfetalness alone method on maternal anxiety and prenatal attachment in pregnant women. The main questions it aims to answer are:
- H1: Tele-nursing-supported Mindfetalness method will significantly reduce state anxiety (STAI-S) levels in pregnant women over time compared to Mindfetalness alone method.
- H2: Tele-nursing-supported Mindfetalness method will significantly reduce trait anxiety (STAI-T) levels in pregnant women over time compared to Mindfetalness alone method.
- H3: Tele-nursing-supported Mindfetalness method will significantly increase prenatal attachment (PAI) levels in pregnant women over time compared to Mindfetalness alone method.
Researches will compare tele-nursing-supported Mindfetalness to Mindfetalness alone to see if tele-nursing support significiantly reduces state and trait anxiety levels and significiantly increases prenatal attachment levels in pregnant women over time.
Participants will;
- Attend a single, face-to-face Mindfetalness training session at the beginning of the study to learn technique and application procedures correctly.
- Practice Mindfetalness method daily for 15 minutes throughout the 8-week study period.
- Complete a daily compliance tracking chart to record their adherence to the Mindfetalness method of their practice.
- Complete the State-Trait Anxiety Inventory (STAI) and the Prenatal Attachment Inventory (PAI) at baseline and during 4th and 8th-week follow-up measurements to track changes over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study design is a prospective, two-arm (two experimental groups), parallel-group, double-blind, individual-randomised, and embedded mixed-methods clinical trial. This trial will be reported following the CONSORT, COREQ and GRAMMS statement. While quantitative data for the study are being collected, qualitative data will be collected from participants who have completed the research process (participants in the eighth week of the intervention).To capture the subjective depth of the Mindfetalness experience, qualitative interviews were integrated to enrich the quantitative findings on maternal anxiety and prenatal attachment. This mixed-methods approach provides a holistic understanding of the intervention's impact from the participants' perspective.
| Arm | Type | Receives |
|---|---|---|
| Mindfetalness Alone | Active comparator | Behavioral: Mindfetalness AloneParticipants in this group will: * Complete the baseline assessments (pre-test) prior to the intervention. * Receive a standardized training session on the Mindfetalness method. * Be provided with a compliance tracking chart to monitor their daily practice. * Perform the Mindfetalness application daily for 15 minutes throughout the intervention period. * Submit photographs of their compliance tracking charts to the researchers at week 4 and week 8 to document to the method. * Undergo follow-up measurements at week 4 and week 8 to evaluate the ongoing effects of the intervention. * Following the completion of the research, participants who volunteered for the qualitative phase will be identified, and randomly selected individuals from this volunteer pool will be invited to participate in the interviews to ensure diverse perspectives. |
| Tele-Nursing-Supported Mindfetalness | Active comparator | Behavioral: Tele-Nursing-Supported MindfetalnessParticipants in this group will: * Complete the baseline assessments prior to the intervention. * Receive a standardized training session on the Mindfetalness method. * Be provided with a compliance tracking chart to monitor their daily practice. * Perform the Mindfetalness application daily for 15 minutes throughout the intervention period. * Receive weekly SMS reminders throughout the study to encourage consistent practice and maintain motivation for the Mindfetalness method. * Participate in tele-nursing consultation calls during the 2nd and 6th weeks of the intervention to receive guidance, address concerns, and obtain emotional support regarding the method. * Submit photographs of their compliance tracking charts to the researchers at week 4 and week 8 to document to the method. * Undergo follow-up measurements at week 4 and 8 to evaluate the ongoing effects of the intervention. * Post-intervention, random interviews will be conducted with volunteer participants to gain deeper insights. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Being at the 28th week of gestation
- Having a singleton pregnancy
- Being primiparous
- Being literate
Key exclusion criteria (6 listed)
- Having a high-risk pregnancy (e.g., preterm labor threat, preeclampsia, gestational diabetes, placenta previa, or cardiac disease).
- Presence of diagnosed fetal health complications (e.g., intrauterine growth restriction [IUGR], fetal anomalies).
- Currently monitoring fetal movements using any other conventional fetal movement counting methods.
- Presence of any communication barriers (e.g., hearing, speech, or language impairments).
- History or current diagnosis of chronic or psychiatric illness.
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 |
|---|---|---|
| Tele-Nursing-Supported MindfetalnessAlso: Tele-nursing-supported Mindfetalness method, Mindfetalness Training for Fetal Movement AwarenessThe intervention involves the Mindfetalness method, a subjective practice focused on sensing the quality of fetal movements rather than numerical counting. All participants receive a single, face-to-face training session and are instructed to practice the method for 15 minutes daily throughout the 8-week study period. Adherence is monitored via a daily compliance tracking chart, with photos of the logs submitted to researchers at weeks 4 and 8. Tele-nursing-supported uniquely receives additional tele-nursing support, consisting of weekly motivational SMS reminders and two structured phone consultations (at weeks 2 and 6) to provide professional guidance and emotional support, ensuring the method is applied correctly and addressing participants' concerns. | Behavioural | Tele-Nursing-Supported Mindfetalness |
| Mindfetalness AloneAlso: Mindfetalness Training for Fetal Movement AwarenessThe intervention involves the Mindfetalness method, a subjective practice focused on sensing the quality of fetal movements rather than numerical counting. All participants receive a single, face-to-face training session and are instructed to practice the method for 15 minutes daily throughout the 8-week study period. Adherence is monitored via a daily compliance tracking chart, with photos of the logs submitted to researchers at weeks 4 and 8. | Behavioural | Mindfetalness Alone |
Primary outcome
Maternal state anxiety (State-Trait Anxiety Inventory)
Time frame: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.
It will be used to assess maternal state anxiety levels. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). The total score ranges from 20 to 80, with higher scores indicating higher levels of state anxiety. In the Turkish adaptation of the scale, the Cronbach's alpha reliability coefficient was reported as 0.94.
Maternal Trait Anxiety (State-Trait Anxiety Inventory)
Time frame: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.
It will be used to assess maternal trait anxiety levels. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much so). The total score ranges from 20 to 80, with higher scores indicating higher levels of trait anxiety. In the Turkish adaptation of the scale, the Cronbach's alpha reliability coefficient was reported as 0.83.
Prenatal Attachment (Prenatal Attachment Inventory)
Time frame: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.
It will be used to assess the level of attachment between pregnant women and their babies. The inventory is a four-point Likert-type scale, with each item scored on a scale of 1 to 4, and consists of a total of 21 items. The total score ranges from 21 to 84, with higher scores indicating higher levels of prenatal attachment. The Crohnbach's alpha consistent for the Turkish version of the scale is 0.84.
3 secondary outcomes
Adherence to the Mindfetalness method (Daily Adherence Log)
Time frame: To verify adherence, participants are required to submit photographs of the completed forms via a secure messaging platform (WhatsApp) at the end of week 4 (first form) and week 8 (second form).
Healthcare Utilization for Perceived Reduced Fetal Movement
Time frame: Hospital admissions will be recorded and evaluated at the end of weeks 4 and 8.
The subjective effects, experiences and satisfaction levels of the intervention among pregnant women (Semi-structured interview form)
Time frame: Qualitative data will be collected at the end of week 8, following the completion of the 8-week intervention and final quantitative assessments.
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 6 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the confidentiality and privacy of the participants.
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.
Nevin ÇITAK BİLGİN, Associate Professor, PhD principal investigator
Abant Izzet Baysal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Nursing-Supported Mindfetalness and Mindfetalness Alone in people with Tele-nursing and Fetal Movement, run by Abant Izzet Baysal University at 2 sites 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 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 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 2 sites 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?
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?
Contact Büşra Boğa, Research Assistant, MSc (+90 03742534520 ext. 6124, busra.boga@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal state anxiety (State-Trait Anxiety Inventory) (time frame: A repeated measures design will be employed, with data collected at three time points: baseline, week 4, and week 8 to evaluate the intervention's impact over time.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.