RhinoplastyNCT06771297
Education's Impact on Involuntary Thoughts and Healing in Rhinoplasty Patients
A study testing nursing education in people with Rhinoplasty and Nursing Education, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
With planned trainings prepared by taking into account the needs of patients and given by nurses, levels of anxiety and involuntary thoughts can be reduced and the quality of service and recovery can be increased. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoplasty, Nursing Education
- What is being tested?
- nursing education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced planned nose surgery for the first time,
- Volunteer to participate in the research,
- 18 years and above,
- Mental status is healthy,
- Having no vision, hearing or speech problems,
- Patients who speak Turkish will be included in the study.
Who cannot join
- Having had nose surgery before,
- Communication is a problem,
- Patients who do not want to participate in the study voluntarily will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Patients Undergoing Rhinoplasty Surgery on Involuntary Thoughts and Recovery Quality
With planned trainings prepared by taking into account the needs of patients and given by nurses, levels of anxiety and involuntary thoughts can be reduced and the quality of service and recovery can be increased. In this context, this research was planned to determine the effect of preoperative education given to patients undergoing rhinoplasty surgery on involuntary thoughts and recovery quality.
Read the detailed description
Rhinoplasty , nose shape And function disorders elimination for the purpose of often applied surgical One is the procedure . Higher ego respect , aesthetics your concerns elimination And life of the quality increasing for the purpose of today rhinoplasty And other aesthetic surgical of procedures APPLICATION in frequency increase surgery while being observed to the process connected aspect developing anxiety because of dissatisfaction And pain like negative seeing the experiences frequency increasing . Age , personal features , history experiences And to do to applications connected aspect individual Differences by showing together hospital lying down require , general anesthesia under implementation , specific One duration work vital And social from life far to stay like A lot factor rhinoplasty surgery before And after that individuals anxiety to live From where is happening . Moreover surgical of the procedure aesthetic for purposes being done to have surgery after that get will be conclusion with relating to obscurity sense of And external appearances given high importance patients anxiety levels affecting other factors aspect is shown . To do to transactions aimed at information lack of patients anxiety level affecting -most basis from factors someone is is stated . patients requirements into consideration by taking prepared And nurses by given planned trainings with anxiety And request female thought levels reducing And patients improvement of the quality increasing is intended .
patients requirements into consideration by taking prepared And nurses by given planned trainings with anxiety And request female thought levels can be reduced And service And improvement of the quality can be increased . In this context This research rhinoplasty surgery will be to patients operation pre- given your education request female thoughts And improvement to the quality effect to determine for the purpose of was the plan .
Approach and Methods to be Applied:
of research Place and Time of Making : This research was conducted by Iğdır Dr. It will be carried out at Nevruz Erez State Hospital, Plastic Surgery Clinic between January 2024 and December 2024.
Population and Sample of the Research: Population of the research, Iğdır Dr. Nevruz Erez State Hospital, Plastic Surgery Clinic Patients who underwent rhinoplasty surgery and applied between January 2024 and December 2024 will be created. The sample will consist of 82 patients selected by simple random sampling method and meeting the research criteria.
Method of the research : It was planned as a randomized controlled experimental.
of research Variables : Dependant Variables : Prompt Female Thoughts Scale , Surgery Post Improvement index Independent Variables : surgery pre- education Control Variables : Patient's age , gender , marital status , education level , more before operation being situation , else One health problem being status Data Collection and Initiatives: Research for First of all , Ataturk University Medicine Faculty Ethic From the Board approval And of research will be carried out from hospitals written permissions will be taken . Necessary permissions after receiving After , January 2024- December 2024 between Iğdır Dr. Research at Nevruz Erez State Hospital, Plastic Surgery Clinic to join acceptance who makes And sample being elected to the criteria wake up patients to work including will be . Research of your data "Patient Introduction " in the meeting Form ", " Request Female Thoughts Scale " and " Surgery Post Improvement Index " will be used . Data collecting tools This way Will be implemented : Researcher by surveys face to the face meeting technique using to patients will be filled . Control in the group patients , surgery One day Before Patient Introduction form And Request Female Thoughts scale will be implemented . Operation in the morning Request Female Thoughts scale again will be implemented . Operation post- whereas discharged while being And discharged 1 week after later Operation Post Improvement index will be applied. Patients in the control group will receive routine nursing care.
the experimental group to patients from surgery One day Before Patient Introduction form And Request Female Thoughts scale will be implemented . Later computer in the environment prepared slide with his offering rhinoplasty process pre- And may develop after complications And at home care process with relating to education will be given . Later prepared education booklet to patients will be given . Operation in the morning Request Female Thoughts scale again will be implemented . Operation post- whereas discharged while being And discharged 1 week after later Operation Post Improvement index will be applied.
Data Collection Tools:
Introductory Information Form: It consists of questions containing the demographic characteristics of the patient, prepared by the researchers in line with the literature for the purpose of collecting research data.
Operation Pre Request Female Thoughts scale Operation pre- in patients happened anxiety to research And operation pre- of anxiety fast One way evaluation to ensure For this purpose, Crockett et al. by has developed . of scale Turkish validity And reliability Cakir and by Karabulut has been made . Control loss concern size And process until later related anxiety size to be about into two subdimensions has . out of 20 items formed This each question of the scale for evaluation: (0) never , (1) sometimes , (2) often chic and (3) mostly shaped and 4-point Likert to type has . From scale 0-60 point can be obtained . 15 or more high One score , clinic aspect important to anxiety reaching patients Trustworthy One way detection it does .
Postoperative Recovery Index (PRI): The Postoperative Recovery Index was developed by Butler et al. in 2012 (26) and was validated in Turkish by Cengiz and Aygin (2019) (27). The index consists of 5 sub-dimensions and 25 items. The sub-dimensions include psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-related symptoms. Sub-dimension scores are calculated by summing the relevant item scores and taking their arithmetic mean. The total score is determined by summing all item scores and calculating the arithmetic mean. Higher scores indicate greater difficulties in postoperative recovery, while lower scores suggest easier recovery (27). In the study by Cengiz and Aygin, the Cronbach's alpha coefficient for the PRI was determined to be 0.96 (27).
Evaluation of Data: Statistical Package for the Social Science (SPSS) statistical package will be applied in the coding and statistical analysis of the data. Descriptive statistics, t-test for dependent and independent groups, and correlation tests will be used to evaluate the data.
Ethical Aspect of the Research: In order to conduct the research, Ethics Committee approval will be obtained from Atatürk University Faculty of Medicine Ethics Committee Presidency. In addition, Iğdır Dr. where the research will be carried out . Legal permissions will be obtained from Nevruz Erez State Hospital . Since answers must be given voluntarily in all research that obtains information, importance will be given to the voluntary participation of individuals to be included in the research. In addition, their approval (principle of informed consent) will be obtained verbally after the purpose of the research and the purposes for which the results will be used are explained. The "Respect for Autonomy" principle will be fulfilled by stating that they are free to participate in the research or not, and the "Confidentiality and Protection of Confidentiality" principle will be fulfilled by informing the patients participating in the research that their information will be kept confidential. Since individual rights must be protected in research, the Declaration of Helsinki on human rights will be adhered to during the study.
- Conditions
- Rhinoplasty, Nursing Education
- Being tested
- nursing education
- Keywords
- rhinoplasty, nursing, involuntary thought, quality of recovery, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing educationOther
Nursing training will be given before rhinoplasty surgery. As a result, patients' involuntary thoughts and quality of recovery will be questioned.
| Study group | Role | What they receive |
|---|---|---|
| standard care and nursing education | Experimental | Nursing training will be provided the day before the surgery. Receives: Other: nursing education |
| standard care | Other | Nursing training will not be provided and will only receive standard care in the hospital. Receives: Other: nursing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Intrusive Thoughts Inventory (PITI)
This scale aims to investigate preoperative anxiety in patients and provide a rapid assessment of this anxiety. It consists of two sub-dimensions: concern about loss of control and concern related to post-procedural outcomes. The scale contains 20 items, with responses evaluated on a 4-point Likert scale ranging from (0) never, (1) sometimes, (2) often, to (3) mostly. Scores range from 0 to 60, with a score of 15 or higher reliably identifying patients with clinically significant anxiety.
Measured: surgery day morning (1 day)
Preoperative Intrusive Thoughts Inventory (PITI)
This scale aims to investigate preoperative anxiety in patients and provide a rapid assessment of this anxiety. It consists of two sub-dimensions: concern about loss of control and concern related to post-procedural outcomes. The scale contains 20 items, with responses evaluated on a 4-point Likert scale ranging from (0) never, (1) sometimes, (2) often, to (3) mostly. Scores range from 0 to 60, with a score of 15 or higher reliably identifying patients with clinically significant anxiety.
Time Frame: 1 day
Measured: Day before surgery (1 day)
Secondary outcomes (2)
Postoperative Recovery Index (PRI)
The index consists of five sub-dimensions: psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-related symptoms. Scores range from 25 to 125. The total score for the PRI general survey is calculated by summing all 25 items and taking the arithmetic mean. Higher scores indicate greater difficulties in postoperative recovery, while lower scores suggest an easier recovery process.
Measured: 1st day after surgery
Postoperative Recovery Index (PRI)
The index consists of five sub-dimensions: psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-related symptoms. Scores range from 25 to 125. The total score for the PRI general survey is calculated by summing all 25 items and taking the arithmetic mean. Higher scores indicate greater difficulties in postoperative recovery, while lower scores suggest an easier recovery process.
Time Frame: 1 day and 1 week
Measured: 1st week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies 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
- The population of the research is Iğdır, Dr. Patients who underwent rhinoplasty surgery and applied to Nevruz Erez State Hospital Plastic Surgery Clinic and Ear, Nose and Throat Clinic between January 2024 and December 2024 were included. The sample will consist of 82 patients selected by simple random sampling method and meeting the research criteria. The sample was determined by G-Power.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turgut Sohret, Ataturk University
- Investigators
- Neziha Karabulut, Prof.Dr., Study chair, ResearcherTurgut Şöhret, Lecturer, Study chair, ResearcherYasemin Ay Karadaş, Lecturer, Study chair, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771297
- Sponsor's protocol ID
- AtaturkUniNursing
- Status last verified
- Jan 2025
- First submitted
- 26 Jun 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Patients Undergoing Rhinoplasty Surgery on Involuntary Thoughts and Recovery Quality
- ClinicalTrials.gov ID
- NCT06771297
- Acronym / sponsor ID
- AtaturkUniNursing
- Conditions
- Rhinoplasty, Nursing Education
- Keywords
- rhinoplasty, nursing, involuntary thought, quality of recovery, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Jan 2025 (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.
With planned trainings prepared by taking into account the needs of patients and given by nurses, levels of anxiety and involuntary thoughts can be reduced and the quality of service and recovery can be increased. In this context, this research was planned to determine the effect of preoperative education given to patients undergoing rhinoplasty surgery on involuntary thoughts and recovery quality.
Detailed description
Rhinoplasty , nose shape And function disorders elimination for the purpose of often applied surgical One is the procedure . Higher ego respect , aesthetics your concerns elimination And life of the quality increasing for the purpose of today rhinoplasty And other aesthetic surgical of procedures APPLICATION in frequency increase surgery while being observed to the process connected aspect developing anxiety because of dissatisfaction And pain like negative seeing the experiences frequency increasing . Age , personal features , history experiences And to do to applications connected aspect individual Differences by showing together hospital lying down require , general anesthesia under implementation , specific One duration work vital And social from life far to stay like A lot factor rhinoplasty surgery before And after that individuals anxiety to live From where is happening . Moreover surgical of the procedure aesthetic for purposes being done to have surgery after that get will be conclusion with relating to obscurity sense of And external appearances given high importance patients anxiety levels affecting other factors aspect is shown . To do to transactions aimed at information lack of patients anxiety level affecting -most basis from factors someone is is stated . patients requirements into consideration by taking prepared And nurses by given planned trainings with anxiety And request female thought levels reducing And patients improvement of the quality increasing is intended .
patients requirements into consideration by taking prepared And nurses by given planned trainings with anxiety And request female thought levels can be reduced And service And improvement of the quality can be increased . In this context This research rhinoplasty surgery will be to patients operation pre- given your education request female thoughts And improvement to the quality effect to determine for the purpose of was the plan .
Approach and Methods to be Applied:
of research Place and Time of Making : This research was conducted by Iğdır Dr. It will be carried out at Nevruz Erez State Hospital, Plastic Surgery Clinic between January 2024 and December 2024.
Population and Sample of the Research: Population of the research, Iğdır Dr. Nevruz Erez State Hospital, Plastic Surgery Clinic Patients who underwent rhinoplasty surgery and applied between January 2024 and December 2024 will be created. The sample will consist of 82 patients selected by simple random sampling method and meeting the research criteria.
Method of the research : It was planned as a randomized controlled experimental.
of research Variables : Dependant Variables : Prompt Female Thoughts Scale , Surgery Post Improvement index Independent Variables : surgery pre- education Control Variables : Patient's age , gender , marital status , education level , more before operation being situation , else One health problem being status Data Collection and Initiatives: Research for First of all , Ataturk University Medicine Faculty Ethic From the Board approval And of research will be carried out from hospitals written permissions will be taken . Necessary permissions after receiving After , January 2024- December 2024 between Iğdır Dr. Research at Nevruz Erez State Hospital, Plastic Surgery Clinic to join acceptance who makes And sample being elected to the criteria wake up patients to work including will be . Research of your data "Patient Introduction " in the meeting Form ", " Request Female Thoughts Scale " and " Surgery Post Improvement Index " will be used . Data collecting tools This way Will be implemented : Researcher by surveys face to the face meeting technique using to patients will be filled . Control in the group patients , surgery One day Before Patient Introduction form And Request Female Thoughts scale will be implemented . Operation in the morning Request Female Thoughts scale again will be implemented . Operation post- whereas discharged while being And discharged 1 week after later Operation Post Improvement index will be applied. Patients in the control group will receive routine nursing care.
the experimental group to patients from surgery One day Before Patient Introduction form And Request Female Thoughts scale will be implemented . Later computer in the environment prepared slide with his offering rhinoplasty process pre- And may develop after complications And at home care process with relating to education will be given . Later prepared education booklet to patients will be given . Operation in the morning Request Female Thoughts scale again will be implemented . Operation post- whereas discharged while being And discharged 1 week after later Operation Post Improvement index will be applied.
Data Collection Tools:
Introductory Information Form: It consists of questions containing the demographic characteristics of the patient, prepared by the researchers in line with the literature for the purpose of collecting research data.
Operation Pre Request Female Thoughts scale Operation pre- in patients happened anxiety to research And operation pre- of anxiety fast One way evaluation to ensure For this purpose, Crockett et al. by has developed . of scale Turkish validity And reliability Cakir and by Karabulut has been made . Control loss concern size And process until later related anxiety size to be about into two subdimensions has . out of 20 items formed This each question of the scale for evaluation: (0) never , (1) sometimes , (2) often chic and (3) mostly shaped and 4-point Likert to type has . From scale 0-60 point can be obtained . 15 or more high One score , clinic aspect important to anxiety reaching patients Trustworthy One way detection it does .
Postoperative Recovery Index (PRI): The Postoperative Recovery Index was developed by Butler et al. in 2012 (26) and was validated in Turkish by Cengiz and Aygin (2019) (27). The index consists of 5 sub-dimensions and 25 items. The sub-dimensions include psychological symptoms, physical activities, general symptoms, bowel symptoms, and desire-related symptoms. Sub-dimension scores are calculated by summing the relevant item scores and taking their arithmetic mean. The total score is determined by summing all item scores and calculating the arithmetic mean. Higher scores indicate greater difficulties in postoperative recovery, while lower scores suggest easier recovery (27). In the study by Cengiz and Aygin, the Cronbach's alpha coefficient for the PRI was determined to be 0.96 (27).
Evaluation of Data: Statistical Package for the Social Science (SPSS) statistical package will be applied in the coding and statistical analysis of the data. Descriptive statistics, t-test for dependent and independent groups, and correlation tests will be used to evaluate the data.
Ethical Aspect of the Research: In order to conduct the research, Ethics Committee approval will be obtained from Atatürk University Faculty of Medicine Ethics Committee Presidency. In addition, Iğdır Dr. where the research will be carried out . Legal permissions will be obtained from Nevruz Erez State Hospital . Since answers must be given voluntarily in all research that obtains information, importance will be given to the voluntary participation of individuals to be included in the research. In addition, their approval (principle of informed consent) will be obtained verbally after the purpose of the research and the purposes for which the results will be used are explained. The "Respect for Autonomy" principle will be fulfilled by stating that they are free to participate in the research or not, and the "Confidentiality and Protection of Confidentiality" principle will be fulfilled by informing the patients participating in the research that their information will be kept confidential. Since individual rights must be protected in research, the Declaration of Helsinki on human rights will be adhered to during the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The population of the research is Iğdır, Dr. Patients who underwent rhinoplasty surgery and applied to Nevruz Erez State Hospital Plastic Surgery Clinic and Ear, Nose and Throat Clinic between January 2024 and December 2024 were included. The sample will consist of 82 patients selected by simple random sampling method and meeting the research criteria. The sample was determined by G-Power.
| Arm | Type | Receives |
|---|---|---|
| standard care and nursing education | Experimental | Other: nursing educationNursing training will be provided the day before the surgery. |
| standard care | Other | Other: nursing educationNursing training will not be provided and will only receive standard care in the hospital. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Experienced planned nose surgery for the first time,
- Volunteer to participate in the research,
- 18 years and above,
- Mental status is healthy,
- Having no vision, hearing or speech problems,
Key exclusion criteria (3 listed)
- Having had nose surgery before,
- Communication is a problem,
- Patients who do not want to participate in the study voluntarily will not be included.
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 |
|---|---|---|
| nursing educationNursing training will be given before rhinoplasty surgery. As a result, patients' involuntary thoughts and quality of recovery will be questioned. | Other | standard care, standard care and nursing education |
Primary outcome
Preoperative Intrusive Thoughts Inventory (PITI)
Time frame: surgery day morning (1 day)
This scale aims to investigate preoperative anxiety in patients and provide a rapid assessment of this anxiety. It consists of two sub-dimensions: concern about loss of control and concern related to post-procedural outcomes. The scale contains 20 items, with responses evaluated on a 4-point Likert scale ranging from (0) never, (1) sometimes, (2) often, to (3) mostly. Scores range from 0 to 60, with a score of 15 or higher reliably identifying patients with clinically significant anxiety.
Preoperative Intrusive Thoughts Inventory (PITI)
Time frame: Day before surgery (1 day)
This scale aims to investigate preoperative anxiety in patients and provide a rapid assessment of this anxiety. It consists of two sub-dimensions: concern about loss of control and concern related to post-procedural outcomes. The scale contains 20 items, with responses evaluated on a 4-point Likert scale ranging from (0) never, (1) sometimes, (2) often, to (3) mostly. Scores range from 0 to 60, with a score of 15 or higher reliably identifying patients with clinically significant anxiety. Time Frame: 1 day
2 secondary outcomes
Postoperative Recovery Index (PRI)
Time frame: 1st day after surgery
Postoperative Recovery Index (PRI)
Time frame: 1st week after surgery
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 17 Jan 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Neziha Karabulut, Prof.Dr. study chair
Researcher
Turgut Şöhret, Lecturer study chair
Researcher
Yasemin Ay Karadaş, Lecturer study chair
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nursing education in people with Rhinoplasty and Nursing Education, run by Ataturk Training and Research 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 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. 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?
Preoperative Intrusive Thoughts Inventory (PITI) (time frame: surgery day morning (1 day)). The study lists 2 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 17 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.