NursesNursiaticNCT06636604
Development of a Decision Support Algorithm (DSA) for Detecting the Sciatic Nerve in Safe Injection Practices
A study testing DSA(Decision Support Algorithm) in people with Nurses and Injection Site, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This project aims to develop an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurses, Injection Site, Sciatic Nerve
- What is being tested?
- DSA(Decision Support Algorithm)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Nov 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant volunteered to take part in the research and is over 18 years of age.
- They have applied to the emergency department for an intramuscular injection and have not experienced any injection-related complications before.
- There is no risk of developing complications during the injection phase, such as bleeding, coagulation disorders, or drug allergy.
- Additionally, there is no scarring or abscess at the injection site.
- There should be no communication barriers, such as a psychological disorder or inability to speak Turkish.
- To participate in this study, it is necessary to be able to read and sign the informed consent form in Turkish.
Who cannot join
- Excluded were individuals who did not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to develop an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.
In the first phase of the project,developed an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.
Read more
In the second phase of the project, with the integration of the Decision Support Algorithm (DSA) on a computer accompanied by a doctor and an engineer, the presence of the sciatic nerve was tested on 30 volunteers. The test resulted in achieving a 100% sciatic nerve image, confirming the reliability of the DSA.
Subsequently, information about the algorithm was provided to volunteers and nurses in the emergency department of Sakarya Training and Research Hospital who applied for intramuscular injection.
Read the detailed description
This project aims to develop an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.
Method This project was conducted between 01-05-2022 and 01-11-2023.
Data Collection Phase In the first phase of the project, approximately 1500 ultrasound images of the sciatic nerve were obtained from 50 volunteers in right and left positions. Subsequently, the sciatic nerve was labeled on these images. The dimensions of the collected data were normalized, noise reduction was applied, histogram equalization was performed, and class imbalance was addressed by balancing the data. The data were further augmented by applying techniques such as rotation, translation, reflection, and zooming. The YOLOv7 model was chosen for model selection. Parameter optimization was performed for YOLOv7, and preprocessing and data augmentation processes were completed for training the model. The hyperparameters of the YOLOv7 model were manually adjusted, followed by the use of automatic hyperparameter tuning tools, significantly enhancing the model's performance.
Integration and Testing Phase of the DSA In the second phase of the project, with the integration of the Decision Support Algorithm (DSA) on a computer accompanied by a doctor and an engineer, the presence of the sciatic nerve was tested on 30 volunteers subjects based on signals received through a USG probe.
Clinical Trial Phase Subsequently, information about the algorithm was provided to volunteers and nurses in the emergency department of Sakarya Training and Research Hospital who applied for intramuscular injection. Under the supervision of volunteer nurses, project coordinators, and researchers, injections were administered to 30 patients using the DSA and to 30 patients using the traditional method. After completing the injections, nurses filled out and signed the "System Usability Scale" (SUS). Additionally, the "Visual Pain Scale" and "Satisfaction Visual Scale for Injections" were used to assess patients' pain after the injection. Pain levels of volunteer patients were compared immediately after injection and 15 minutes later.
Keywords Nurse, sciatic nerve, decision support algorithm.
- Conditions
- Nurses, Injection Site, Sciatic Nerve, Pain, Satisfaction, Patient
- Being tested
- DSA(Decision Support Algorithm)
- Keywords
- Nurse, Sciatic nerve, Decision support algorithm, Intramuscular injection, Pain, Satisfaction, Patients
- Medical subject headings
- Pain, Patient Satisfaction, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSA(Decision Support Algorithm)Other
Intramuscular injection will be given to 30 volunteer patients using the decision support algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group: The effect of the decision support algorithm on pain and satisfaction during intramuscular injection will be examined. Receives: Other: DSA(Decision Support Algorithm) |
| Control Group | No intervention | There is no intervention. Pain and satisfaction during intramuscular injection will be examined. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain conditions of the patients after the injection will be determined.
The patient marks his or her pain on a 10 cm ruler, on one end of which the painlessness is written, and on the other end, the most severe possible pain is written.
Measured: Baseline
Pain conditions of the patients after the injection will be determined.
The patient marks his or her pain on a 10 cm ruler, on one end of which the painlessness is
Measured: 15 minutes
Secondary outcomes (2)
The patients' satisfaction levels after the injection will be determined.
Visual Analog Scale (VAS) was used to evaluate the patients' satisfaction levels with the injection.
Measured: Baseline
The patients' satisfaction levels after the injection will be determined.
Visual Analog Scale (VAS) was used to evaluate the patients' satisfaction levels with the injection.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Işık ATASOY, MsC, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636604
- Sponsor's protocol ID
- IŞIK ATASOY
- Acronym
- Nursiatic
- Status last verified
- Oct 2024
- First submitted
- 1 Mar 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Decision Support Algorithm (DSA) for Detecting the Sciatic Nerve in Safe Injection Practices
- ClinicalTrials.gov ID
- NCT06636604
- Acronym / sponsor ID
- Nursiatic / IŞIK ATASOY
- Conditions
- Nurses, Injection Site, Sciatic Nerve, Pain, Satisfaction, Patient
- Keywords
- Nurse, Sciatic nerve, Decision support algorithm, Intramuscular injection, Pain, Satisfaction, Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to develop an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.
In the first phase of the project,developed an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.
In the second phase of the project, with the integration of the Decision Support Algorithm (DSA) on a computer accompanied by a doctor and an engineer, the presence of the sciatic nerve was tested on 30 volunteers. The test resulted in achieving a 100% sciatic nerve image, confirming the reliability of the DSA.
Subsequently, information about the algorithm was provided to volunteers and nurses in the emergency department of Sakarya Training and Research Hospital who applied for intramuscular injection.
Detailed description
This project aims to develop an artificial intelligence-based decision support algorithm (DSA) for the detection of the sciatic nerve in safe intramuscular injection applications.
Method This project was conducted between 01-05-2022 and 01-11-2023.
Data Collection Phase In the first phase of the project, approximately 1500 ultrasound images of the sciatic nerve were obtained from 50 volunteers in right and left positions. Subsequently, the sciatic nerve was labeled on these images. The dimensions of the collected data were normalized, noise reduction was applied, histogram equalization was performed, and class imbalance was addressed by balancing the data. The data were further augmented by applying techniques such as rotation, translation, reflection, and zooming. The YOLOv7 model was chosen for model selection. Parameter optimization was performed for YOLOv7, and preprocessing and data augmentation processes were completed for training the model. The hyperparameters of the YOLOv7 model were manually adjusted, followed by the use of automatic hyperparameter tuning tools, significantly enhancing the model's performance.
Integration and Testing Phase of the DSA In the second phase of the project, with the integration of the Decision Support Algorithm (DSA) on a computer accompanied by a doctor and an engineer, the presence of the sciatic nerve was tested on 30 volunteers subjects based on signals received through a USG probe.
Clinical Trial Phase Subsequently, information about the algorithm was provided to volunteers and nurses in the emergency department of Sakarya Training and Research Hospital who applied for intramuscular injection. Under the supervision of volunteer nurses, project coordinators, and researchers, injections were administered to 30 patients using the DSA and to 30 patients using the traditional method. After completing the injections, nurses filled out and signed the "System Usability Scale" (SUS). Additionally, the "Visual Pain Scale" and "Satisfaction Visual Scale for Injections" were used to assess patients' pain after the injection. Pain levels of volunteer patients were compared immediately after injection and 15 minutes later.
Keywords Nurse, sciatic nerve, decision support algorithm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: DSA(Decision Support Algorithm)Experimental Group: The effect of the decision support algorithm on pain and satisfaction during intramuscular injection will be examined. |
| Control Group | No intervention | –There is no intervention. Pain and satisfaction during intramuscular injection will be examined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The participant volunteered to take part in the research and is over 18 years of age.
- They have applied to the emergency department for an intramuscular injection and have not experienced any injection-related complications before.
- There is no risk of developing complications during the injection phase, such as bleeding, coagulation disorders, or drug allergy.
- Additionally, there is no scarring or abscess at the injection site.
- There should be no communication barriers, such as a psychological disorder or inability to speak Turkish.
Key exclusion criteria (1 listed)
- Excluded were individuals who did not meet the inclusion criteria.
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 |
|---|---|---|
| DSA(Decision Support Algorithm)Intramuscular injection will be given to 30 volunteer patients using the decision support algorithm. | Other | Experimental Group |
Primary outcome
Pain conditions of the patients after the injection will be determined.
Time frame: Baseline
The patient marks his or her pain on a 10 cm ruler, on one end of which the painlessness is written, and on the other end, the most severe possible pain is written.
Pain conditions of the patients after the injection will be determined.
Time frame: 15 minutes
The patient marks his or her pain on a 10 cm ruler, on one end of which the painlessness is
2 secondary outcomes
The patients' satisfaction levels after the injection will be determined.
Time frame: Baseline
The patients' satisfaction levels after the injection will be determined.
Time frame: 15 minutes
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 10 Oct 2024.
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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.
Işık ATASOY, MsC principal investigator
Sakarya 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 DSA(Decision Support Algorithm) in people with Nurses and Injection Site, run by Sakarya 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 6 inclusion and 1 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 10 Oct 2024. 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?
Pain conditions of the patients after the injection will be determined. (time frame: Baseline). 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 10 Oct 2024.