Pain ManagementNCT05523518
Which Technique is Effective in Reducing the Pain of Peripheral Intravenous Catheterization in Pediatric Patients, Infra-Red Light or Buzzy®?
A study testing The Buzzy® and The AccuVein® in people with Pain Management, run by Uludag University.
Trial summary
The aim of this study is to examine the effect on the pain developing from peripheral intravenous catheterization (IV) in pediatric patients of an infra-red vein visualization device, AccuVein®, and Buzzy®, which can simultaneously produce vibration and cold. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Pain Management
- What is being tested?
- The Buzzy® and The AccuVein®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2022to 20 Nov 2022
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being aged 7-12 years
- Themselves and their parents participating voluntarily in the study
- Being able to correctly evaluate the Facial Expressions Pain Rating Scale
- Not having, in the area or extremity in which the implementation will be conducted, anything which could interfere with the intervention, such as symptoms or signs of infection, scar tissue, vein or nerve damage or loss of sensation
- Not having used an analgesic in the previous six hours
- Being able to speak and understand Turkish
Show all 9Show fewer
- Having no visual, auditory or speaking problems
- Not having any condition which could affect the sensation of pain
- Having a peripheral intravenous catheter for the first time in the emergency service
Who cannot join
- Being mentally retarded
- Having a chronic or fatal illness
- Having any psychiatric diagnosis
- Being unconscious or being unable to communicate verbally
- Not having a vein opened for the first time
- Agitation in themselves or their family
Show all 9Show fewer
- Themselves or their parents not wanting to participate in the study, or wishing to withdraw at some point during the study
- Any situation which could affect the sensation of pain
- Being younger than seven or older than 12 years
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to examine the effect on the pain developing from peripheral intravenous catheterization (IV) in pediatric patients of an infra-red vein visualization device, AccuVein®, and Buzzy®, which can simultaneously produce vibration and cold.
The research is planned as a prospective, randomized controlled study with an experimental design. Research data collection will be conducted at the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University. The research sample will consist of children aged 7-12 years who attend the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University for diagnosis or treatment, who have been ordered a peripheral intravenous catheter for intravenous treatment by a doctor, and whose participation is voluntarily accepted by themselves and their parents. It was calculated as a result of power analysis that the minimum sample size is 90 child patients, with 30 in each group, to reach an 80% power level, accepting a type I error level of 5%. Pediatric patients who fit the inclusion criteria of the study will be assigned to implementation and control groups with the use of a computer-generated randomization list, according to their age and gender.
Read more
An Individual Data Collection Form and the Facial Expressions Pain Rating Scale will be used to collect data by face to face interview.
Peripheral intravenous catheterization will be implemented on the veins of either the right or the left arm. The procedural steps of the standard vein entry protocol will be followed with all of the children in the implementation and control groups.
In addition to the standard vein entry protocol, the following interventions will be conducted with the pediatric patients in the implementation groups.
Peripheral intravenous catheterization with pediatric patients in the Buzzy® group: From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.)
Peripheral intravenous catheterization with pediatric patients in the AccuVein® group: In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry.
Peripheral intravenous catheterization with pediatric patients in the control group: With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device.
Immediately after the procedure has been performed, an assistant researcher who is unaware of the catheterization method used will ask the children of all groups to assess their pain levels with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form. While the study is being conducted, the necessary measures will be taken to prevent the children included in the study from influencing each other, such as not allowing them to see the method applied to the other children.
Read the detailed description
The aim of this study is to examine the effect on the pain developing from peripheral intravenous catheterization (IV) in pediatric patients of an infra-red vein visualization device, AccuVein®, and Buzzy®, which can simultaneously produce vibration and cold.
The research is planned as a prospective, randomized controlled study with an experimental design. Research data collection will be conducted at the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University. The research sample will consist of children aged 7-12 years who attend the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University for diagnosis or treatment, who have been ordered a peripheral intravenous catheter for intravenous treatment by a doctor, and whose participation is voluntarily accepted by themselves and their parents.
The size of the study sample was statistically determined with the program G*Power 3.1.7. It was calculated as a result of power analysis that the minimum sample size is 90 child patients, with 30 in each group, to reach an 80% power level, accepting a type I error level of 5%. Pediatric patients who fit the inclusion criteria of the study will be assigned to implementation and control groups with the use of a computer-generated randomization list, according to their age and gender. That is, the study group in which the children are placed will be determined by a randomization method according to a randomization list.
An Individual Data Collection Form and the Facial Expressions Pain Rating Scale will be used to collect data by face to face interview.
Individual Data Collection Form: This form will have questions on the children's age, gender, height, weight, the vein where the catheter is located (left or right), and the duration of catheterization.
Facial Expressions Pain Rating Scale: This scale depends on various different facial expressions depicted visually. It is used in clinical pediatric implementations to measure pain severity. The expression of no pain is generally shown with a smiling face, and the worst pain with a crying face.
The pediatric patients to be included in the study and their parents will be informed about the research, and oral approval will be obtained from the children and oral and written approval will be obtained from their parents. After securing their voluntary participation, the children will be assigned to implementation and control groups. After that, the children's descriptive characteristics will be taken, and recorded on the Individual Data Collection Form. Following this, the use of the Facial Expressions Pain Rating Scale will be explained to the children in simple language that they can understand. Peripheral intravenous catheterization will be performed by an experienced nurse working in the pediatric emergency service who is involved in the research. A number 24 peripheral intravenous catheter will be used with all of the pediatric patients. Children in whom the entry to the vein is unsuccessful will not be included in the study. Peripheral intravenous catheterization will be implemented on the veins of either the right or the left arm. The procedural steps of the standard vein entry protocol will be followed with all of the children in the implementation and control groups.
In addition to the standard vein entry protocol, the following interventions will be conducted with the pediatric patients in the implementation groups.
Peripheral intravenous catheterization with pediatric patients in the Buzzy® group: From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.)
Peripheral intravenous catheterization with pediatric patients in the AccuVein® group: In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry.
Peripheral intravenous catheterization with pediatric patients in the control group: With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device.
Immediately after the procedure has been performed, an assistant researcher who is unaware of the catheterization method used will ask the children of all groups to assess their pain levels with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form. While the study is being conducted, the necessary measures will be taken to prevent the children included in the study from influencing each other, such as not allowing them to see the method applied to the other children.
- Conditions
- Pain Management
- Being tested
- The Buzzy®, The AccuVein®
- Keywords
- pain control, nonpharmacological method, AccuVein®, Buzzy®, pediatric patients, peripheral intravenous catheterization
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Buzzy®Device
From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.)
The AccuVein®Device
In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry.
| Study group | Role | What they receive |
|---|---|---|
| The Buzzy® group | Experimental | From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.) Receives: Device: The Buzzy® |
| the AccuVein® group | Experimental | In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry. Receives: Device: The AccuVein® |
| The control group | No intervention | With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Facial Expressions Pain Rating Scale
pain severity in mm
(Immediately after the procedure has been performed, an assistant researcher will ask the children of all groups to assess their pain severity with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form)
Measured: 4 months
Secondary outcomes (4)
weight
weight in kilograms
Measured: 4 months
height
height in meters
Measured: 4 months
body mass index (BMI)
BMI in kg/m^2
Measured: 4 months
duration of catheterization
duration of catheterization in second
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start31 Aug 2022 (estimated)
- Primary completion10 Nov 2022 (estimated)
- Study completion20 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yilmaz, PhD, Uludag University
- Investigators
- Seçil Salarcı, MSc, Study chair, Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523518
- Sponsor's protocol ID
- 2022-10/22
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Technique is Effective in Reducing the Pain of Peripheral Intravenous Catheterization in Pediatric Patients, Infra-Red Light or Buzzy®?
- ClinicalTrials.gov ID
- NCT05523518
- Acronym / sponsor ID
- 2022-10/22
- Conditions
- Pain Management
- Keywords
- pain control, nonpharmacological method, AccuVein®, Buzzy®, pediatric patients, peripheral intravenous catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (estimated)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 20 Nov 2022 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effect on the pain developing from peripheral intravenous catheterization (IV) in pediatric patients of an infra-red vein visualization device, AccuVein®, and Buzzy®, which can simultaneously produce vibration and cold.
The research is planned as a prospective, randomized controlled study with an experimental design. Research data collection will be conducted at the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University. The research sample will consist of children aged 7-12 years who attend the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University for diagnosis or treatment, who have been ordered a peripheral intravenous catheter for intravenous treatment by a doctor, and whose participation is voluntarily accepted by themselves and their parents. It was calculated as a result of power analysis that the minimum sample size is 90 child patients, with 30 in each group, to reach an 80% power level, accepting a type I error level of 5%. Pediatric patients who fit the inclusion criteria of the study will be assigned to implementation and control groups with the use of a computer-generated randomization list, according to their age and gender.
An Individual Data Collection Form and the Facial Expressions Pain Rating Scale will be used to collect data by face to face interview.
Peripheral intravenous catheterization will be implemented on the veins of either the right or the left arm. The procedural steps of the standard vein entry protocol will be followed with all of the children in the implementation and control groups.
In addition to the standard vein entry protocol, the following interventions will be conducted with the pediatric patients in the implementation groups.
Peripheral intravenous catheterization with pediatric patients in the Buzzy® group: From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.)
Peripheral intravenous catheterization with pediatric patients in the AccuVein® group: In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry.
Peripheral intravenous catheterization with pediatric patients in the control group: With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device.
Immediately after the procedure has been performed, an assistant researcher who is unaware of the catheterization method used will ask the children of all groups to assess their pain levels with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form. While the study is being conducted, the necessary measures will be taken to prevent the children included in the study from influencing each other, such as not allowing them to see the method applied to the other children.
Detailed description
The aim of this study is to examine the effect on the pain developing from peripheral intravenous catheterization (IV) in pediatric patients of an infra-red vein visualization device, AccuVein®, and Buzzy®, which can simultaneously produce vibration and cold.
The research is planned as a prospective, randomized controlled study with an experimental design. Research data collection will be conducted at the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University. The research sample will consist of children aged 7-12 years who attend the Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University for diagnosis or treatment, who have been ordered a peripheral intravenous catheter for intravenous treatment by a doctor, and whose participation is voluntarily accepted by themselves and their parents.
The size of the study sample was statistically determined with the program G*Power 3.1.7. It was calculated as a result of power analysis that the minimum sample size is 90 child patients, with 30 in each group, to reach an 80% power level, accepting a type I error level of 5%. Pediatric patients who fit the inclusion criteria of the study will be assigned to implementation and control groups with the use of a computer-generated randomization list, according to their age and gender. That is, the study group in which the children are placed will be determined by a randomization method according to a randomization list.
An Individual Data Collection Form and the Facial Expressions Pain Rating Scale will be used to collect data by face to face interview.
Individual Data Collection Form: This form will have questions on the children's age, gender, height, weight, the vein where the catheter is located (left or right), and the duration of catheterization.
Facial Expressions Pain Rating Scale: This scale depends on various different facial expressions depicted visually. It is used in clinical pediatric implementations to measure pain severity. The expression of no pain is generally shown with a smiling face, and the worst pain with a crying face.
The pediatric patients to be included in the study and their parents will be informed about the research, and oral approval will be obtained from the children and oral and written approval will be obtained from their parents. After securing their voluntary participation, the children will be assigned to implementation and control groups. After that, the children's descriptive characteristics will be taken, and recorded on the Individual Data Collection Form. Following this, the use of the Facial Expressions Pain Rating Scale will be explained to the children in simple language that they can understand. Peripheral intravenous catheterization will be performed by an experienced nurse working in the pediatric emergency service who is involved in the research. A number 24 peripheral intravenous catheter will be used with all of the pediatric patients. Children in whom the entry to the vein is unsuccessful will not be included in the study. Peripheral intravenous catheterization will be implemented on the veins of either the right or the left arm. The procedural steps of the standard vein entry protocol will be followed with all of the children in the implementation and control groups.
In addition to the standard vein entry protocol, the following interventions will be conducted with the pediatric patients in the implementation groups.
Peripheral intravenous catheterization with pediatric patients in the Buzzy® group: From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.)
Peripheral intravenous catheterization with pediatric patients in the AccuVein® group: In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry.
Peripheral intravenous catheterization with pediatric patients in the control group: With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device.
Immediately after the procedure has been performed, an assistant researcher who is unaware of the catheterization method used will ask the children of all groups to assess their pain levels with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form. While the study is being conducted, the necessary measures will be taken to prevent the children included in the study from influencing each other, such as not allowing them to see the method applied to the other children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Buzzy® group | Experimental | Device: The Buzzy®From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.) |
| the AccuVein® group | Experimental | Device: The AccuVein®In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry. |
| The control group | No intervention | –With the pediatric patients in the control group, no intervention will be performed before or during the procedure, and routine IV catheterization will be carried out without the use of any device. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Being aged 7-12 years
- Themselves and their parents participating voluntarily in the study
- Being able to correctly evaluate the Facial Expressions Pain Rating Scale
- Not having, in the area or extremity in which the implementation will be conducted, anything which could interfere with the intervention, such as symptoms or signs of infection, scar tissue, vein or nerve damage or loss of sensation
- Not having used an analgesic in the previous six hours
Key exclusion criteria (9 listed)
- Being mentally retarded
- Having a chronic or fatal illness
- Having any psychiatric diagnosis
- Being unconscious or being unable to communicate verbally
- Not having a vein opened for the first time
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 |
|---|---|---|
| The Buzzy®From one minute before the location of the catheter and until the end of the procedure, the researchers will place the Buzzy® device approximately 5cm above the area where the procedure will take place, with its wings under it. The gel in its wings will have been previously frozen solid in a refrigerator. In this way, vibration and cold will be applied, and immediately afterwards, vein entry will be performed. (For the children's safety, a piece of thin sterile gauze will be placed on the area in order to prevent direct contact between the ice wings and the skin.) | Device | The Buzzy® group |
| The AccuVein®In this group, the veins in the area where the entry is to be performed will be visualized with the AccuVein® infrared vein visualization device, and the standard catheter implementation will be performed in the vein which is decided on for entry. | Device | the AccuVein® group |
Primary outcome
Pain Scores on the Facial Expressions Pain Rating Scale
Time frame: 4 months
pain severity in mm (Immediately after the procedure has been performed, an assistant researcher will ask the children of all groups to assess their pain severity with the Facial Expressions Pain Rating Scale, and the scores indicated will be recorded on the data collection form)
4 secondary outcomes
weight
Time frame: 4 months
height
Time frame: 4 months
body mass index (BMI)
Time frame: 4 months
duration of catheterization
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- 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.
Seçil Salarcı, MSc study chair
Pediatric Emergency Service of the Health Research and Application Center of Bursa Uludağ University
Questions about this trial
What is this clinical trial studying?
A study testing The Buzzy® and The AccuVein® in people with Pain Management, run by Uludag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Yılmaz, PhD (05073580330, dilekk@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Facial Expressions Pain Rating Scale (time frame: 4 months). 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 31 Aug 2022.