Pregnancy RelatedNCT05804838
Investigation of the Effect of Mindfulness-Based Stress Reduction Program on in Pregnant Women
A study testing Mindfulness stress reduction program group in people with Pregnancy Related and Mediation, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effects of the Mindfulness-Based Stress Reduction Program, which is one of the popular concepts of the 21st century, on depression, psychological well-being and prenatal attachment, which are likely to occur as a result of increased stress during an important period that requires… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Mediation, Depression
- What is being tested?
- Mindfulness stress reduction program group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2023to 30 Aug 2024
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 20-35 years old
- Being her first pregnancy
- Being between 13 and 24 weeks of gestation
- Having applied to the pregnant outpatient clinic where the research will be conducted.
- Not having a hearing-visual impairment
- Ability to read and write Turkish
Show all 10Show fewer
- Volunteering to participate in the research
- Not having a diagnosis that would constitute a physical activity disability.
- Agreeing to participate in the 8-week MBSR training
- Being able to use ZOOM Cloud Meetings program
Who cannot join
- Being diagnosed with acute/chronic disease during pregnancy
- Having a diagnosis of mental illness in the pregnant
- Multiple pregnancy
- Having participated in any awareness-based training program in the last 1 year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Umraniye Training and Research Hospital
Istanbul, Umraniye, 11340168
About this study
Official title: Investigation of the Effect of Mindfulness-Based Stress Reduction Program on Depression, Psychological Well-Being and Prenatal Attachment in Pregnant Women
This study was planned to examine the effects of the Mindfulness-Based Stress Reduction Program, which is one of the popular concepts of the 21st century, on depression, psychological well-being and prenatal attachment, which are likely to occur as a result of increased stress during an important period that requires adjustment as a result of physical, mental and cognitive changes during pregnancy. It will be conducted in a randomized parallel controlled experimental design type using Consolidated Standards of Reporting Trials (CONSORT) guidelines. It is planned to be carried out with the ZOOM Cloud Meetings program, which is an online education platform, with pregnant women who apply to the Health Sciences University Ümraniye Training and Research Hospital pregnancy polyclinic in the Ümraniye district of Istanbul. The universe of the research will be the pregnant women who applied to the Health Sciences University Ümraniye Training and Research Hospital pregnant outpatient clinic. Primiparous pregnant women who meet the inclusion criteria and willingly agree to participate in the study will be included in the study. 54 people in the intervention group, 54 people in the control group, and a total of 108 people will be taken.
While the Conscious Awareness-Based Stress Reduction Program adapted for pregnant women will be applied to the intervention group, routine follow-up will be applied to the control group within the scope of the outpatient clinic follow-up of the relevant institution. Informed Voluntary Consent Form, Descriptive Characteristics Information Form, Psychological Well-Being Scale, Beck Depression Scale, Prenatal Attachment Scale and Conscious Awareness Scale will be administered to the participants included in the study. As a result of the findings, the discussion and results of the study will be written.
Read the detailed description
Studies with a high level of evidence evaluating the effectiveness of mindfulness-based practices in obstetrics are limited. It is stated that little is known about the effects of mindfulness-based interventions, which is one of the non-pharmacological methods in the prenatal period, on pregnant women. In a limited number of studies, it is noted that mindfulness-based approaches used in the prenatal period increase the level of awareness by reducing depression, anxiety and anxiety levels. Studies on how to improve the importance of depression, psychological well-being and the bond established with the fetus during pregnancy have been limited to routine birth preparation trainings.
With the importance of living in the moment, focusing on the moment and staying in the moment in the 21st century, mindfulness programs increase the quality of instant life. Especially during the pregnancy period, where many changes are experienced, the studies that adapted the Mindfulness-Based Stress Reduction Program were quite inadequate.
In the literature, many mindfulness-based programs, including the mindfulness-based stress reduction program, have been used in health areas outside the field of midwifery and evidence-based benefits have been demonstrated. However, there is no study examining depression, psychological well-being, and prenatal attachment levels with mindfulness-based stress reduction. The design of the study gives originality to the study with this aspect. In line with the results of the research, in case of methods/methods with which depression, psychological well-being and prenatal attachment efficiency can be determined during pregnancy, compliance with the pregnancy process, reduction in pregnancy complaints, less need for medical intervention and increase in the number of spontaneous vaginal deliveries in line with the preference of the woman in the delivery room, postpartum mother-infant attachment, Considering that there will be an increase in compliance with the breastfeeding process and newborn care, it can be presented as an alternative method in pregnant training in the preparation process for childbirth.
- Conditions
- Pregnancy Related, Mediation, Depression, Maternal-Fetal Relations
- Being tested
- Mindfulness stress reduction program group
- Keywords
- depression, conscious awareness, midwifery, prenatal attachment, pregnancy
- Medical subject headings
- Negotiating, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness stress reduction program groupOther
Conscious Awareness Based Stress Reduction program will be applied to women in this group, which will last for 8 weeks. Informed Voluntary Consent Form, Descriptive Characteristics Information Form, Psychological Well-Being Scale, Beck Depression Scale, Prenatal Attachment Scale and Conscious Awareness Scale will be administered to the pregnant women who make up the intervention group before the implementation of the Mindfulness-Based Stress Reduction program. The intervention group will receive 1 session per week. Each session will last 80 minutes. After completing the 8-week MBSR program, data collection forms will be re-applied to the pregnant women in the intervention group and posttest-1 measurements will be made. After the posttest-1 measurements, the pregnants in the intervention group will be given posttest-2 measurements of the pregnants in the intervention group, 1 month after the measurements.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Group | Experimental | Research inclusion criteria
* Being between 20-35 years old
* Being her first pregnancy
* Being between 13 and 24 weeks of gestation
* Having applied to the pregnant outpatient clinic where the research will be conducted.
* Not having a hearing-visual impairment
* Ability to read and write Turkish
* Volunteering to participate in the research
* Not having a diagnosis that would constitute an obstacle to physical activity
* Agreeing to participate in the 8-week MBSR training
* Being able to use ZOOM Cloud Meetings program Receives: Other: Mindfulness stress reduction program group |
| Control Group | No intervention | Participants in this group received routine antenatal care, including standard clinical assessments and pregnancy education classes that did not include Mindfulness. No Mindfulness-Based Stress Reduction intervention was provided. Data collection forms (Descriptive Characteristics Information Form, Psychological Well-Being Scale, Beck Depression Scale, Prenatal Attachment Scale) were administered at the same time points as the intervention group; the Mindfulness Scale was not administered to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological well-being scale
The reliability study, the cronbach alpha coefficient was determined as .80. Its consists of a single sub-dimension and 8 items. The items of the scale consist of an answer scale of (1) Strongly disagree, (2) Disagree, (3) Slightly disagree, (4) Undecided, (5) Slightly Agree, (6) Agree, (7) Strongly Agree.
All items of the scale are expressed positively. The scores that can be obtained from the scale range from 8 to 56, and it is stated that the person with a high score has a certain psychological resource and power.
The application time for each pregnant takes approximately 5 minutes.
Measured: at inclusion
Beck depression scale
This scale is a 21-item self-assessment scale and measures depressive symptoms and characteristic approaches.
It provides a four-point Likert-type measurement. Each item gets progressively increasing points between 0 and 3, and the total score is obtained by summing them up. Each item was given a score between 0 and 3, and the highest score that could be obtained from the scale was calculated as 63 and the lowest score as 0.
A high score on the scale indicates that the severity or level of depression is high.
The application time for each pregnant takes approximately 20 minutes.
Measured: at inclusion
Prenatal attachment scale
It is a 15-item scale. High scores on the scale indicate high conscious awareness. It is a 6-point Likert-type scale (almost always, often, sometimes, rarely, quite rarely, almost never).
The application time for each pregnant takes approximately 25 minutes.
Measured: at inclusion
Conscious awareness scale
Scale is a 15-item scale that measures the general tendency to be aware of and attentive to momentary experiences in daily life.
The Conscious Awareness Scale has a single factor structure and gives a single total score.
High scores on the scale indicate high conscious awareness. The Conscious Awareness Scale is a 6-point Likert type scale (almost always, often, sometimes, rarely, quite rarely, almost never).
The validity and reliability results of the Conscious Awareness Scale have shown that the Conscious Awareness Scale is a highly valid and reliable measurement tool.
The internal consistency coefficient (coefficient alpha) of the scale is 0.82. The application time for each pregnant takes approximately 10 minutes.
Measured: at inclusion
Secondary outcomes (4)
Psychological well-being scale
The reliability study, the cronbach alpha coefficient was determined as .80. Its consists of a single sub-dimension and 8 items. The items of the scale consist of an answer scale of (1) Strongly disagree, (2) Disagree, (3) Slightly disagree, (4) Undecided, (5) Slightly Agree, (6) Agree, (7) Strongly Agree.
All items of the scale are expressed positively. The scores that can be obtained from the scale range from 8 to 56, and it is stated that the person with a high score has a certain psychological resource and power.
The application time for each pregnant takes approximately 5 minutes.
Measured: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Beck depression scale
This scale is a 21-item self-assessment scale and measures depressive symptoms and characteristic approaches.
It provides a four-point Likert-type measurement. Each item gets progressively increasing points between 0 and 3, and the total score is obtained by summing them up. Each item was given a score between 0 and 3, and the highest score that could be obtained from the scale was calculated as 63 and the lowest score as 0.
A high score on the scale indicates that the severity or level of depression is high.
The application time for each pregnant takes approximately 20 minutes.
Measured: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Prenatal attachment scale
It is a 15-item scale. High scores on the scale indicate high conscious awareness. It is a 6-point Likert-type scale (almost always, often, sometimes, rarely, quite rarely, almost never).
The application time for each pregnant takes approximately 25 minutes.
Measured: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Conscious awareness scale
Scale is a 15-item scale that measures the general tendency to be aware of and attentive to momentary experiences in daily life.
The Conscious Awareness Scale has a single factor structure and gives a single total score.
High scores on the scale indicate high conscious awareness. The Conscious Awareness Scale is a 6-point Likert type scale (almost always, often, sometimes, rarely, quite rarely, almost never).
The validity and reliability results of the Conscious Awareness Scale have shown that the Conscious Awareness Scale is a highly valid and reliable measurement tool.
The internal consistency coefficient (coefficient alpha) of the scale is 0.82. The application time for each pregnant takes approximately 10 minutes.
Measured: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start28 May 2023
- Primary completion30 Jul 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled treatments will be carried out in a design. These randomized controlled restrictions should be followed by the Consolidated Standards of Reporting Trials (CONSORT) 2010 guideline controls. The study will consist of an Intervention and a control group.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Ebru Sağıroğlu, Uskudar University
- Investigators
- Yasemin Aydın Kartal, Ass.Prof.Dr, Study director, Saglik Bilimleri UniversitesiEbru Sağıroğlu, PhD.Stu., Principal investigator, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804838
- Sponsor's protocol ID
- Uskudar University ESagiroglu
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Mindfulness-Based Stress Reduction Program on Depression, Psychological Well-Being and Prenatal Attachment in Pregnant Women
- ClinicalTrials.gov ID
- NCT05804838
- Acronym / sponsor ID
- Uskudar University ESagiroglu
- Conditions
- Pregnancy Related, Mediation, Depression, Maternal-Fetal Relations
- Keywords
- depression, conscious awareness, midwifery, prenatal attachment, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 28 May 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was planned to examine the effects of the Mindfulness-Based Stress Reduction Program, which is one of the popular concepts of the 21st century, on depression, psychological well-being and prenatal attachment, which are likely to occur as a result of increased stress during an important period that requires adjustment as a result of physical, mental and cognitive changes during pregnancy. It will be conducted in a randomized parallel controlled experimental design type using Consolidated Standards of Reporting Trials (CONSORT) guidelines. It is planned to be carried out with the ZOOM Cloud Meetings program, which is an online education platform, with pregnant women who apply to the Health Sciences University Ümraniye Training and Research Hospital pregnancy polyclinic in the Ümraniye district of Istanbul. The universe of the research will be the pregnant women who applied to the Health Sciences University Ümraniye Training and Research Hospital pregnant outpatient clinic. Primiparous pregnant women who meet the inclusion criteria and willingly agree to participate in the study will be included in the study. 54 people in the intervention group, 54 people in the control group, and a total of 108 people will be taken.
While the Conscious Awareness-Based Stress Reduction Program adapted for pregnant women will be applied to the intervention group, routine follow-up will be applied to the control group within the scope of the outpatient clinic follow-up of the relevant institution. Informed Voluntary Consent Form, Descriptive Characteristics Information Form, Psychological Well-Being Scale, Beck Depression Scale, Prenatal Attachment Scale and Conscious Awareness Scale will be administered to the participants included in the study. As a result of the findings, the discussion and results of the study will be written.
Detailed description
Studies with a high level of evidence evaluating the effectiveness of mindfulness-based practices in obstetrics are limited. It is stated that little is known about the effects of mindfulness-based interventions, which is one of the non-pharmacological methods in the prenatal period, on pregnant women. In a limited number of studies, it is noted that mindfulness-based approaches used in the prenatal period increase the level of awareness by reducing depression, anxiety and anxiety levels. Studies on how to improve the importance of depression, psychological well-being and the bond established with the fetus during pregnancy have been limited to routine birth preparation trainings.
With the importance of living in the moment, focusing on the moment and staying in the moment in the 21st century, mindfulness programs increase the quality of instant life. Especially during the pregnancy period, where many changes are experienced, the studies that adapted the Mindfulness-Based Stress Reduction Program were quite inadequate.
In the literature, many mindfulness-based programs, including the mindfulness-based stress reduction program, have been used in health areas outside the field of midwifery and evidence-based benefits have been demonstrated. However, there is no study examining depression, psychological well-being, and prenatal attachment levels with mindfulness-based stress reduction. The design of the study gives originality to the study with this aspect. In line with the results of the research, in case of methods/methods with which depression, psychological well-being and prenatal attachment efficiency can be determined during pregnancy, compliance with the pregnancy process, reduction in pregnancy complaints, less need for medical intervention and increase in the number of spontaneous vaginal deliveries in line with the preference of the woman in the delivery room, postpartum mother-infant attachment, Considering that there will be an increase in compliance with the breastfeeding process and newborn care, it can be presented as an alternative method in pregnant training in the preparation process for childbirth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled treatments will be carried out in a design. These randomized controlled restrictions should be followed by the Consolidated Standards of Reporting Trials (CONSORT) 2010 guideline controls. The study will consist of an Intervention and a control group.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Group | Experimental | Other: Mindfulness stress reduction program groupResearch inclusion criteria * Being between 20-35 years old * Being her first pregnancy * Being between 13 and 24 weeks of gestation * Having applied to the pregnant outpatient clinic where the research will be conducted. * Not having a hearing-visual impairment * Ability to read and write Turkish * Volunteering to participate in the research * Not having a diagnosis that would constitute an obstacle to physical activity * Agreeing to participate in the 8-week MBSR training * Being able to use ZOOM Cloud Meetings program |
| Control Group | No intervention | –Participants in this group received routine antenatal care, including standard clinical assessments and pregnancy education classes that did not include Mindfulness. No Mindfulness-Based Stress Reduction intervention was provided. Data collection forms (Descriptive Characteristics Information Form, Psychological Well-Being Scale, Beck Depression Scale, Prenatal Attachment Scale) were administered at the same time points as the intervention group; the Mindfulness Scale was not administered to this group. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Being between 20-35 years old
- Being her first pregnancy
- Being between 13 and 24 weeks of gestation
- Having applied to the pregnant outpatient clinic where the research will be conducted.
- Not having a hearing-visual impairment
Key exclusion criteria (4 listed)
- Being diagnosed with acute/chronic disease during pregnancy
- Having a diagnosis of mental illness in the pregnant
- Multiple pregnancy
- Having participated in any awareness-based training program in the last 1 year
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 |
|---|---|---|
| Mindfulness stress reduction program groupConscious Awareness Based Stress Reduction program will be applied to women in this group, which will last for 8 weeks. Informed Voluntary Consent Form, Descriptive Characteristics Information Form, Psychological Well-Being Scale, Beck Depression Scale, Prenatal Attachment Scale and Conscious Awareness Scale will be administered to the pregnant women who make up the intervention group before the implementation of the Mindfulness-Based Stress Reduction program. The intervention group will receive 1 session per week. Each session will last 80 minutes. After completing the 8-week MBSR program, data collection forms will be re-applied to the pregnant women in the intervention group and posttest-1 measurements will be made. After the posttest-1 measurements, the pregnants in the intervention group will be given posttest-2 measurements of the pregnants in the intervention group, 1 month after the measurements. | Other | Mindfulness Group |
Primary outcome
Psychological well-being scale
Time frame: at inclusion
The reliability study, the cronbach alpha coefficient was determined as .80. Its consists of a single sub-dimension and 8 items. The items of the scale consist of an answer scale of (1) Strongly disagree, (2) Disagree, (3) Slightly disagree, (4) Undecided, (5) Slightly Agree, (6) Agree, (7) Strongly Agree. All items of the scale are expressed positively. The scores that can be obtained from the scale range from 8 to 56, and it is stated that the person with a high score has a certain psychological resource and power. The application time for each pregnant takes approximately 5 minutes.
Beck depression scale
Time frame: at inclusion
This scale is a 21-item self-assessment scale and measures depressive symptoms and characteristic approaches. It provides a four-point Likert-type measurement. Each item gets progressively increasing points between 0 and 3, and the total score is obtained by summing them up. Each item was given a score between 0 and 3, and the highest score that could be obtained from the scale was calculated as 63 and the lowest score as 0. A high score on the scale indicates that the severity or level of depression is high. The application time for each pregnant takes approximately 20 minutes.
Prenatal attachment scale
Time frame: at inclusion
It is a 15-item scale. High scores on the scale indicate high conscious awareness. It is a 6-point Likert-type scale (almost always, often, sometimes, rarely, quite rarely, almost never). The application time for each pregnant takes approximately 25 minutes.
Conscious awareness scale
Time frame: at inclusion
Scale is a 15-item scale that measures the general tendency to be aware of and attentive to momentary experiences in daily life. The Conscious Awareness Scale has a single factor structure and gives a single total score. High scores on the scale indicate high conscious awareness. The Conscious Awareness Scale is a 6-point Likert type scale (almost always, often, sometimes, rarely, quite rarely, almost never). The validity and reliability results of the Conscious Awareness Scale have shown that the Conscious Awareness Scale is a highly valid and reliable measurement tool. The internal consistency coefficient (coefficient alpha) of the scale is 0.82. The application time for each pregnant takes approximately 10 minutes.
4 secondary outcomes
Psychological well-being scale
Time frame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Beck depression scale
Time frame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Prenatal attachment scale
Time frame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
Conscious awareness scale
Time frame: At the end of the Mindfulness-Based Stress Reduction Program (week 8)
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 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Aydın Kartal, Ass.Prof.Dr study director
Saglik Bilimleri Universitesi
Ebru Sağıroğlu, PhD.Stu. principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness stress reduction program group in people with Pregnancy Related and Mediation, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 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 11 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?
Psychological well-being scale (time frame: at inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.