AspirationNCT05950425
Aspiration Training Given With Different Methods
A study testing Aspiration training in people with Aspiration and Pediatric Intensive Care Unit, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Parents whose children are in intensive care have to cope with many stressors in terms of psychological, physical, economic and social aspects. Especially during the discharge process, many reasons such as the fact that their children have a chronic disease, need for care, parents do not know how to provide the care… 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
- Aspiration, Pediatric Intensive Care Unit
- What is being tested?
- Aspiration training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 30 Jun 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having aspiration application in the treatment of the child
- Parent's ability to read and speak Turkish
- Parent's willingness to participate in the study
- Parent over 18 years of age
- The child has reached the discharge stage
- The mother has not done aspiration before
- Hospitalization of the child in the intensive care unit between the working dates
Who cannot join
- Variation of the child's health status during education
- Parent has a mental illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan Üniversity
Meram, Konya, 42250
About this study
Official title: The Effect of Aspiration Education Given by Different Methods on the Anxiety and Hopelessness Level of Mothers Whose Child is in Intensive Care: A Randomized Controlled Trial
Parents whose children are in intensive care have to cope with many stressors in terms of psychological, physical, economic and social aspects. Especially during the discharge process, many reasons such as the fact that their children have a chronic disease, need for care, parents do not know how to provide the care their children need, the lack of professional health care teams provided by home care in our country, and therefore the care of the children is covered by the families, increase the anxiety levels of the parents. It increases the frequency of hospitalization of children or prolongs the length of stay in the intensive care unit, as appropriate care cannot be provided. In addition, frequent hospitalizations can cause damage to family dynamics. It has been determined that as the child grows, the difficulties experienced in the care of the child, the financial difficulties increase, the worries about the future and the constant relationship with the experts increase the stress of the parents and the stress is in parallel with the level of hopelessness. This is the factor that reinforces the anxiety and hopelessness in the daily life of parents. The fact that mothers whose children are in intensive care do not know the materials used, the procedures performed, the steps of the procedure, and what situations they will encounter at home may increase their stress-anxiety and hopelessness levels. Today, with the rapid development of technology, the use of educational technologies on the basis of learning and teaching has become widespread in health care education in the field of health, as in every field. It is important to address more than one sense organ in order for the education in the field of health to be more effective. Therefore, it is important to reduce the anxiety and hopelessness levels of the parents, to increase the self-confidence of the parents, to see general (physiological and psychological) improvements in children, and to reduce health costs with the training given to mothers with different education methods. The aim of this study is to determine the effect of aspiration training given by different methods on the level of anxiety and hopelessness of mothers whose children are in intensive care.
Read the detailed description
Pediatric Intensive Care Units (PICUs) are units that have the necessary technical equipment and materials in order to maintain the life, care and treatment of children aged 1 month to 18 years who are in need of medical care, with one or more organ failure, and to prevent possible complications. It differs from other pediatric services where professional nursing care is provided with close follow-up and treatment.
Diseases admitted to the PICU include sepsis, status epilepticus, Central Nervous System infection, hepatic coma, animal bites/stings, traumas, intracranial hemorrhage, suffocation, electric shock, and meningococcemia, with the most common pulmonary infection being the most common. Hospitalization of the child for reasons such as illness, accident or injury can cause significant changes in almost the entire life of the family and cause anxiety. The fact that children's illnesses and injuries require hospitalization in intensive care makes the stress more traumatic. Being a member of the intensive care team, nurses, being aware of the stress sources of the parents whose children are hospitalized in the PICU and knowing their reactions can help them to cope with this situation.
There are no professional home care teams in our country to provide home care for children with special needs dependent on medical devices. Therefore, the care needs of these patients are met by their families after discharge. During the rehabilitation process of children with special care needs, the family may have to perform the duties of health professionals such as administering medication or oxygen therapy in general, performing routine maintenance and replacing tracheostomy tubes, maintaining airway patency, maintaining and replacing nasogastric tubes. After discharge, doing these cares takes a large part of the parents' attention, time and costs. It can cause stress, anxiety, and fear. Another factor affecting the anxiety levels of families after discharge is that they do not feel adequately equipped and educated for their children's care at home (aspiration, mechanical ventilator support, etc.), they do not know what to do in an emergency, they do not receive home health care services or they cannot reach enough. These are situations such as fear of being harmed at home because they think that their children are more sensitive and prone to getting sick than other children.
There are factors that prevent parents with special needs children from coping with the negative emotions they experience while raising their children, and one of them is their hope-level cognition and sensory status. This situation may be the factors that turn his daily life into anxiety and reinforce his hopelessness. Parents need to receive some training from nurses in order to fully care for their children who need special care. It is necessary to inform parents about the development of their child's self-care skills, to increase their ability to manage stress and to solve problems, and to encourage parents with the educational content prepared by determining the functions that the child needs care for.
- Conditions
- Aspiration, Pediatric Intensive Care Unit
- Being tested
- Aspiration training
- Keywords
- Educational Methods, Child, Mother, Anxiety, Hopelessness
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration trainingOther
Pre-test application; All mothers whose children are hospitalized in the PICU will be filled in the questionnaires after verbally expressing and signing the informed consent before being admitted to the intensive care unit and starting the education.
In practice; The mother of the child who is planned to be discharged from the intensive care unit is given training a week before. Aspiration training will be given to the Experimental I group with the video method, and to the Experimental II group with the picture training booklet method. The materials of these trainings will be given to the mothers and they will be asked to look after them when they come to the next care.
Final test application; scales will be filled in the mother on the day of the child's discharge.
| Study group | Role | What they receive |
|---|---|---|
| Experimental I group (video training + standard training) | Experimental | This group will be trained with the aspiration training video shot by the researcher on the model. The video content will include the introduction of the materials used in the aspiration application, how to maintain sterility, the position to be given to the child during aspiration, and the sterile aspiration on the model. After obtaining the consent of the mothers in Experiment I group who participated in the study and were assigned by randomization method, they will be taken to the day room of the service and the training video will be watched on the computer. After the end of the video, if they have any questions, they will be answered and they will be taken to their child's intensive care room after wearing the equipment (bonnet, shoe covers, apron, mask) necessary for the standard education and providing hand hygiene. Receives: Other: Aspiration training |
| Experimental II group (education booklet training + standard training) | Experimental | Aspiration training will be given to this group with a picture training booklet. The training booklet includes the purpose of aspiration, the materials to be used, the position to be given to the child during aspiration, the preservation of sterility, and the application of aspiration. Expert opinion will be taken for the training booklet to be used. After obtaining the consent of the mothers in the Experimental II group, who participated in the study and were assigned with the randomization method, they will be taken to the day room of the service and aspiration training will be given with a picture training booklet. After the training, the questions of the mothers will be answered. At the end of the illustrated training booklet training, mothers will be put in the necessary equipment (bone cap, shoe covers, apron, mask) for standard practice training and hand hygiene will be provided and they will be taken to the intensive care environment to their children's rooms. Receives: Other: Aspiration training |
| Control group | No intervention | The routine standard training given to this group in aspiration training will be used. In this training, one-to-one telling and showing are available. After obtaining the consent of the mothers in the control group who participated in the study and were assigned by randomization method, the necessary equipment (bone cap, shoe covers, apron, mask) will be put on and hand hygiene will be provided and they will be taken to the intensive care unit. After the mother is taken to the room where the child is staying, the equipment and apparatus connected to her child (monitor, infusion pump, NG probe, foley catheter, endotracheal tube, tracheostomy, etc.) will be introduced, equipment used in the treatment process of her child (mechanical ventilator, oxygen valve, aspirator, ambu, aspiration). probe, etc.) will be introduced and physical contact with the child will be supported and ensured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form:
The questionnaire prepared by the researcher considering the literature consists of 22 questions. This form consists of three parts: 10 questions about the child, 7 questions about the parent and family characteristics, and 5 questions about the mother's anxiety.
Measured: 1st day
Secondary outcomes (1)
The Beck Hopelessness Scale:
The scale was prepared by Beck et al. in 1974 with Heimber's anxiety about the future scale and with the help of clinicians. Seber (1991) translated it into Turkish in his associate professorship thesis, and then Seber, Dilbaz, Kaptanoğlu, and Tekin, (1993) and Durak (1994) conducted reliability studies. It is a measurement tool prepared to be applied to adolescents and adults in order to measure the negative expectations of the individual for the future. It is a scale consisting of 20 items and scored between 0-1. The score range is 0-20. High scores; indicates hopelessness and low indicates hope. A score of 0-3 indicates no or minimal hopelessness, a score of 4-8 indicates a low level of hopelessness, a score of 9-14 indicates moderate hopelessness, and a score of 15 and above indicates a high level of hopelessness.
Measured: 1st and 8th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start10 Jul 2023
- Primary completion1 May 2024
- Study completion30 Jun 2024
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 AspirationStudies 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
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra Kose, Necmettin Erbakan University
- Investigators
- Semra KÖSE, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950425
- Sponsor's protocol ID
- NEUSKose2
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision to share the study results will be made during the study period or when it is concluded
Publications
Ağdaş D. (2008) Opinions of mothers of children hospitalized in the pediatric service of Cumhuriyet University Hospital regarding patient admission procedures and their expectations from nurses (Master's Thesis). Cumhuriyet University Institute of Health Sciences, Sivas. Ak, B. (2018). Child and nursing approach with chronic and life-threatening/fatal disease. Z. Conk, Z. Başbakkal, H. Bal Yılmaz, B. Bolışık (Ed.) in Pediatric Nursing (pp. 901- 936). Ankara: Academician Bookstore. Akşit S. & Cimete G. (2001) The effect of nursing care applied to mothers on the anxiety level of mothers when the child is admitted to the intensive care unit. C. U. Journal of the School of Nursing. 5(2): 25-36. Asatekin Yazgu, H. (2022). The Effect of Perceived Social Support on Anxiety and Anxiety Levels of Mothers with Their Baby in the Neonatal Intensive Care Unit [Unpublished master's thesis]. Istanbul University. Ayar, G., Şahin, S. , Yazıcı, M. U. , Coşkun, R. , Yakut, H. İ. & Demirel, F. (2015). Evaluation of Home Care Services in Pediatric Patients. Turkish Journal of Pediatrics, 9 (1) , 12-17 Aykanat Girgin, B. & Balcı, S. (2015). Home Care Needs of Physically Handicapped Children and Their Families. Gumushane University Journal of Health Sciences, 4 (2), 305-317 Biket, A. P., & Tönük, S. (2012). Examining the history of pediatric intensive care units and the current situation in Turkey with examples. Sigma, 4, 64-76. Bolışık, B. Z., Akçay Didişen, N., & Yavuz, B. (2014). Investigation of Use of Wet Wipes in Care of Mothers with Inpatient Children in Children's Hospital. Journal of Ege University Faculty of Nursing, 30(1), 91-100. Caicedo, C. (2014). Families With Special Needs Children. Journal of the American Psychiatric Nurses Association, 20(6), 398-407. https://doi.org/10.1177/1078390314561326
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aspiration Education Given by Different Methods on the Anxiety and Hopelessness Level of Mothers Whose Child is in Intensive Care: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05950425
- Acronym / sponsor ID
- NEUSKose2
- Conditions
- Aspiration, Pediatric Intensive Care Unit
- Keywords
- Educational Methods, Child, Mother, Anxiety, Hopelessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 18 Jul 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.
Parents whose children are in intensive care have to cope with many stressors in terms of psychological, physical, economic and social aspects. Especially during the discharge process, many reasons such as the fact that their children have a chronic disease, need for care, parents do not know how to provide the care their children need, the lack of professional health care teams provided by home care in our country, and therefore the care of the children is covered by the families, increase the anxiety levels of the parents. It increases the frequency of hospitalization of children or prolongs the length of stay in the intensive care unit, as appropriate care cannot be provided. In addition, frequent hospitalizations can cause damage to family dynamics. It has been determined that as the child grows, the difficulties experienced in the care of the child, the financial difficulties increase, the worries about the future and the constant relationship with the experts increase the stress of the parents and the stress is in parallel with the level of hopelessness. This is the factor that reinforces the anxiety and hopelessness in the daily life of parents. The fact that mothers whose children are in intensive care do not know the materials used, the procedures performed, the steps of the procedure, and what situations they will encounter at home may increase their stress-anxiety and hopelessness levels. Today, with the rapid development of technology, the use of educational technologies on the basis of learning and teaching has become widespread in health care education in the field of health, as in every field. It is important to address more than one sense organ in order for the education in the field of health to be more effective. Therefore, it is important to reduce the anxiety and hopelessness levels of the parents, to increase the self-confidence of the parents, to see general (physiological and psychological) improvements in children, and to reduce health costs with the training given to mothers with different education methods. The aim of this study is to determine the effect of aspiration training given by different methods on the level of anxiety and hopelessness of mothers whose children are in intensive care.
Detailed description
Pediatric Intensive Care Units (PICUs) are units that have the necessary technical equipment and materials in order to maintain the life, care and treatment of children aged 1 month to 18 years who are in need of medical care, with one or more organ failure, and to prevent possible complications. It differs from other pediatric services where professional nursing care is provided with close follow-up and treatment.
Diseases admitted to the PICU include sepsis, status epilepticus, Central Nervous System infection, hepatic coma, animal bites/stings, traumas, intracranial hemorrhage, suffocation, electric shock, and meningococcemia, with the most common pulmonary infection being the most common. Hospitalization of the child for reasons such as illness, accident or injury can cause significant changes in almost the entire life of the family and cause anxiety. The fact that children's illnesses and injuries require hospitalization in intensive care makes the stress more traumatic. Being a member of the intensive care team, nurses, being aware of the stress sources of the parents whose children are hospitalized in the PICU and knowing their reactions can help them to cope with this situation.
There are no professional home care teams in our country to provide home care for children with special needs dependent on medical devices. Therefore, the care needs of these patients are met by their families after discharge. During the rehabilitation process of children with special care needs, the family may have to perform the duties of health professionals such as administering medication or oxygen therapy in general, performing routine maintenance and replacing tracheostomy tubes, maintaining airway patency, maintaining and replacing nasogastric tubes. After discharge, doing these cares takes a large part of the parents' attention, time and costs. It can cause stress, anxiety, and fear. Another factor affecting the anxiety levels of families after discharge is that they do not feel adequately equipped and educated for their children's care at home (aspiration, mechanical ventilator support, etc.), they do not know what to do in an emergency, they do not receive home health care services or they cannot reach enough. These are situations such as fear of being harmed at home because they think that their children are more sensitive and prone to getting sick than other children.
There are factors that prevent parents with special needs children from coping with the negative emotions they experience while raising their children, and one of them is their hope-level cognition and sensory status. This situation may be the factors that turn his daily life into anxiety and reinforce his hopelessness. Parents need to receive some training from nurses in order to fully care for their children who need special care. It is necessary to inform parents about the development of their child's self-care skills, to increase their ability to manage stress and to solve problems, and to encourage parents with the educational content prepared by determining the functions that the child needs care for.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| Experimental I group (video training + standard training) | Experimental | Other: Aspiration trainingThis group will be trained with the aspiration training video shot by the researcher on the model. The video content will include the introduction of the materials used in the aspiration application, how to maintain sterility, the position to be given to the child during aspiration, and the sterile aspiration on the model. After obtaining the consent of the mothers in Experiment I group who participated in the study and were assigned by randomization method, they will be taken to the day room of the service and the training video will be watched on the computer. After the end of the video, if they have any questions, they will be answered and they will be taken to their child's intensive care room after wearing the equipment (bonnet, shoe covers, apron, mask) necessary for the standard education and providing hand hygiene. |
| Experimental II group (education booklet training + standard training) | Experimental | Other: Aspiration trainingAspiration training will be given to this group with a picture training booklet. The training booklet includes the purpose of aspiration, the materials to be used, the position to be given to the child during aspiration, the preservation of sterility, and the application of aspiration. Expert opinion will be taken for the training booklet to be used. After obtaining the consent of the mothers in the Experimental II group, who participated in the study and were assigned with the randomization method, they will be taken to the day room of the service and aspiration training will be given with a picture training booklet. After the training, the questions of the mothers will be answered. At the end of the illustrated training booklet training, mothers will be put in the necessary equipment (bone cap, shoe covers, apron, mask) for standard practice training and hand hygiene will be provided and they will be taken to the intensive care environment to their children's rooms. |
| Control group | No intervention | –The routine standard training given to this group in aspiration training will be used. In this training, one-to-one telling and showing are available. After obtaining the consent of the mothers in the control group who participated in the study and were assigned by randomization method, the necessary equipment (bone cap, shoe covers, apron, mask) will be put on and hand hygiene will be provided and they will be taken to the intensive care unit. After the mother is taken to the room where the child is staying, the equipment and apparatus connected to her child (monitor, infusion pump, NG probe, foley catheter, endotracheal tube, tracheostomy, etc.) will be introduced, equipment used in the treatment process of her child (mechanical ventilator, oxygen valve, aspirator, ambu, aspiration). probe, etc.) will be introduced and physical contact with the child will be supported and ensured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having aspiration application in the treatment of the child
- Parent's ability to read and speak Turkish
- Parent's willingness to participate in the study
- Parent over 18 years of age
- The child has reached the discharge stage
Key exclusion criteria (2 listed)
- Variation of the child's health status during education
- Parent has a mental 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 |
|---|---|---|
| Aspiration trainingPre-test application; All mothers whose children are hospitalized in the PICU will be filled in the questionnaires after verbally expressing and signing the informed consent before being admitted to the intensive care unit and starting the education. In practice; The mother of the child who is planned to be discharged from the intensive care unit is given training a week before. Aspiration training will be given to the Experimental I group with the video method, and to the Experimental II group with the picture training booklet method. The materials of these trainings will be given to the mothers and they will be asked to look after them when they come to the next care. Final test application; scales will be filled in the mother on the day of the child's discharge. | Other | Experimental I group (video training + standard training), Experimental II group (education booklet training + standard training) |
Primary outcome
Introductory Information Form:
Time frame: 1st day
The questionnaire prepared by the researcher considering the literature consists of 22 questions. This form consists of three parts: 10 questions about the child, 7 questions about the parent and family characteristics, and 5 questions about the mother's anxiety.
1 secondary outcome
The Beck Hopelessness Scale:
Time frame: 1st and 8th day
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 4 Sep 2026.
- BackgroundAğdaş D. (2008) Opinions of mothers of children hospitalized in the pediatric service of Cumhuriyet University Hospital regarding patient admission procedures and their expectations from nurses (Master's Thesis). Cumhuriyet University Institute of Health Sciences, Sivas. Ak, B. (2018). Child and nursing approach with chronic and life-threatening/fatal disease. Z. Conk, Z. Başbakkal, H. Bal Yılmaz, B. Bolışık (Ed.) in Pediatric Nursing (pp. 901- 936). Ankara: Academician Bookstore. Akşit S. & Cimete G. (2001) The effect of nursing care applied to mothers on the anxiety level of mothers when the child is admitted to the intensive care unit. C. U. Journal of the School of Nursing. 5(2): 25-36. Asatekin Yazgu, H. (2022). The Effect of Perceived Social Support on Anxiety and Anxiety Levels of Mothers with Their Baby in the Neonatal Intensive Care Unit [Unpublished master's thesis]. Istanbul University. Ayar, G., Şahin, S. , Yazıcı, M. U. , Coşkun, R. , Yakut, H. İ. & Demirel, F. (2015). Evaluation of Home Care Services in Pediatric Patients. Turkish Journal of Pediatrics, 9 (1) , 12-17 Aykanat Girgin, B. & Balcı, S. (2015). Home Care Needs of Physically Handicapped Children and Their Families. Gumushane University Journal of Health Sciences, 4 (2), 305-317 Biket, A. P., & Tönük, S. (2012). Examining the history of pediatric intensive care units and the current situation in Turkey with examples. Sigma, 4, 64-76. Bolışık, B. Z., Akçay Didişen, N., & Yavuz, B. (2014). Investigation of Use of Wet Wipes in Care of Mothers with Inpatient Children in Children's Hospital. Journal of Ege University Faculty of Nursing, 30(1), 91-100. Caicedo, C. (2014). Families With Special Needs Children. Journal of the American Psychiatric Nurses Association, 20(6), 398-407. https://doi.org/10.1177/1078390314561326
- Individual participant dataSharing planned: No. The decision to share the study results will be made during the study period or when it is concluded
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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.
Semra KÖSE study director
Necmettin Erbakan 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 Aspiration training in people with Aspiration and Pediatric Intensive Care Unit, run by Necmettin Erbakan 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 7 inclusion and 2 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 4 Sep 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?
Introductory Information Form: (time frame: 1st day). 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 NCT05950425, 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 4 Sep 2026.