NCT06636604

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

March 1, 2024

Last Update Submit

October 8, 2024

Conditions

NursesInjection SiteSciatic NervePainSatisfaction, Patient

Keywords

NurseSciatic nerveDecision support algorithmIntramuscular injectionPainSatisfactionPatients

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    15 minutes

Secondary Outcomes (2)

  • The patients' satisfaction levels after the injection will be determined.

    Baseline

  • The patients' satisfaction levels after the injection will be determined.

    15 minutes

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group: The effect of the decision support algorithm on pain and satisfaction during intramuscular injection will be examined.

Other: DSA(Decision Support Algorithm)

Control Group

NO INTERVENTION

There is no intervention. Pain and satisfaction during intramuscular injection will be examined.

Interventions

DSA(Decision Support Algorithm)OTHER

Intramuscular injection will be given to 30 volunteer patients using the decision support algorithm.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPatient SatisfactionPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Işık ATASOY, MsC

    Sakarya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2024

First Posted

October 10, 2024

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

November 1, 2023

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

TU(1)