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IRCT20240127060820N1 IRCT 2024-02-21 University of Kerbala Comparing the Effect of Using Lidocaine Spray and ShotBlocker on Pain Level During Intramuscular Injection: A Clinical Trial RCT Comparing the Effect of Using Lidocaine Spray and ShotBlocker on Pain Level During Intramuscular Injection: A Randomized Control Trial 2023-12-01 anticipated 150 Complete https://irct.ir/trial/75385 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to maintain a transparent and scientifically based randomization process, stratified randomization will be used in assigning participants (Patients receiving intramuscular injections {diclofenac sodium} who are admitted to the emergency department) to intervention (shotblocker and lidocaine spray) and control groups. This method ensures that each participant has an equal chance of being assigned to any group. The process will involve a simple randomization procedure wherein participants will select a color from a sealed envelope containing three colors: blue, yellow, and green. Each color corresponds to a group (blue for the ShotBlocker group, yellow for the lidocaine spray group, and green for the control group), and participants will be allocated randomly among these three groups, Blinding description: the single-blind technique, was employed as the researcher needs to know how the subjects will be treated. Therefore, the study was done whereas the participants were unaware of the interventional group. With the use of this blinding technique, the study results are well shielded from the subject knowledge of the treatment assignment . There have been (153) patients in the sample. Both the intervention groups and the control group obtained an equal number of these subjects . N/A Patients receiving intramuscular injections {diclofenac sodium} who are admitted to the emergency department. Intervention group: The study included adult patients who were chosen based on the aforementioned criteria. The study was carried out in the emergency departments with patients who had been prescribed diclofenac sodium by their physicians. To reassure the participants, the researcher explained the study's aims, duration, and technique in terms of information confidentiality. Following that, the oral and written consents of the patients who will participate in the sample were obtained, as they were randomly divided into three groups (Total 153). This method ensures that each participant has an equal chance of being assigned to any group. The process will involve a simple randomization procedure wherein participants will select a color from a sealed envelope containing three colors: blue, yellow, and green. Each color corresponds to a group (blue for the ShotBlocker group, yellow for the lidocaine spray group, and green for the control group), and participants will be allocated randomly among these three groups .The injection procedure and the randomization method for selecting one of the groups are discussed with participations. The researcher introduced the patients to the Visual Analog Scale (VAS) pain intensity scale before administering the injection, placing a check in front of the number denoting the degree of the pain.. Yes - There is a plan to make this available What will be shared: The data will be the results of Patients receiving intramuscular injections {diclofenac sodium} who are admitted to the emergency department for both intervention and control groups, When: God Willing, once the article is published, the data will be available after 6 months of publication. If the article will be published in a subscribed journal, the data will be available after one year because of the policy of the subscribed journals. To whom: with academic nurses and any researcher who is interested in the data Conditions: The data could be used after getting permission via email. Also, users need to acknowledge the owner. Where to obtain: Users can ask for the data and permission via email. Hameed Muslim is the corresponding author. He will contact whoever he requests the information from. His email is hameed.muslim@s.uokerbala.edu.iq Hameed Muslim works at the Imam Al-Sadiq General Hospital . The address is Al-Hussein neighborhood district, Karbala, Iraq. What processes are involved for a request to access data/document How to obtain: Users can ask for the data and permission via email. Hameed Muslim is the corresponding author. He will contact whoever he requests the information from. His email is hameed.muslim@s.uokerbala.edu.iq Comments:
public Hameed Muslim Hashem
Al-Hussein neighborhood
Karbala Iraq 56001 +964 781 864 0782 hameed.muslim@s.uokerbala.edu.iq University of Kerbala scientific Hameed Muslim Hashem
Al-Hussein neighborhood
Karbala Iraq 56001 +964 781 864 0782 hameed.muslim@s.uokerbala.edu.iq University of Kerbala Iraq Adult participants between the ages of 18 – 60 years old; did not receive analgesics/sedatives during the past 24 hours; voluntary participated in the study; patient did not have fibrosis, wound, infection and tenderness in the injection site: patients who entered the Emergency Department and were prescribed analgesics by the physicians: have no problems communicating and are fully conscious: patient not have diseases Gastric Ulcers and Asthma. 18 years 60 years Both Patients who refused to participate in the study; individuals with communication difficulties or unconsciousness, those with fibrosis, wounds, or infections at the injection site, individuals involved in Road Traffic Accidents (RTA), stab wounds, or bleeding injuries. Patients receiving medication (such as antibiotics or analgesics) intravenously or intramuscularly, pregnant women, and individuals experiencing side effects of Diclofenac Sodium like gastric ulcers and asthma were also excluded from the study Treatment - Other Intervention group: The study included adult patients who were chosen based on the aforementioned criteria. The study was carried out in the emergency departments with patients who had been prescribed diclofenac sodium by their physicians. To reassure the participants, the researcher explained the study's aims, duration, and technique in terms of information confidentiality. Following that, the oral and written consents of the patients who will participate in the sample were obtained, as they were randomly divided into three groups (Total 153). This method ensures that each participant has an equal chance of being assigned to any group. The process will involve a simple randomization procedure wherein participants will select a color from a sealed envelope containing three colors: blue, yellow, and green. Each color corresponds to a group (blue for the ShotBlocker group, yellow for the lidocaine spray group, and green for the control group), and participants will be allocated randomly among these three groups .The injection procedure and the randomization method for selecting one of the groups are discussed with participations. The researcher introduced the patients to the Visual Analog Scale (VAS) pain intensity scale before administering the injection, placing a check in front of the number denoting the degree of the pain. The primary outcome variable is the level of pain during intramuscular injection that can be changed based on using shotblocker and lidocaine spray. Timepoint: immediate after intervention (intramuscular injection ) using visual analog scale and after three weeks to measurement of the primary outcome. Method of measurement: measurement pain level after intramuscular injection by using visual analog scale. The author of the trial is the funding source Approved 2023-11-19 Ethics committee in College of Nursing at University of Karbala Al Iskan Street, Al Hussein District Karbala, Iraq