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IRCT20230714058776N1 IRCT 2024-01-21 College of Nursing, University of Baghdad Reducing Pain Associated with Intravenous Cannulation in School Age Children The Effect of ShotBlocker in Reducing Pain Associated with Peripheral Intravenous Cannulation in School Age Children: A Randomized Controlled Trial (RCT) 2023-07-11 anticipated 128 Complete https://irct.ir/trial/74139 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to maintain a transparent & scientific-based randomization process, simple randomization will be used in assigning participants to 2 intervention & control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below & equal to 3 = control, over 3 =treatment). No allocation concealment will be carried out, Blinding description: Blinding description refers to the process of concealing certain information from participants or researchers in a study or experiment. This is typically done to minimize bias and ensure the integrity of the results. In the context of a randomized control trial, blinding refers to keeping participants and/or researchers unaware of certain details, such as the treatment assignment or the group to which participants belong (e.g., experimental group or control group). This helps to ensure that the study's outcomes are not influenced by expectations or preferences, and that the results are more reliable and objective. N/A Pain management related intravenous cannulation. Intervention group: In the beginning, the patient’s consent is taken, and then a lottery is made to choose the intervention, either Shotblocker or ShotBlocker placebo, then a fill questionnaire, and then the intervention is performed by one of the methods, then the pain intensity is measured using Wong-Baker Faces pain scale. Control group: the intravenous cannulation is given using the traditional method, and then the pain intensity is measured using Wong-Baker Faces pain scale .. Yes - There is a plan to make this available What will be shared: The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals When: God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications To whom: All the related files will be shared with any scientific interested parties. Conditions: It may be used after seeking the author's permission and acknowledging his contribution. Where to obtain: The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: salsabeel.alaa2204m@conursing.uobaghdad.edu.iq How to obtain: N/A Comments: Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.
public Salsabeel Alaa Nasser
Twenty Street
Al-Zubaidiyah Iraq 10001 +964 774 023 1025 salsabeel.alaa2204m@conursing.uobaghdad.edu.iq University of Baghdad,College of Nursing scientific Salsabeel Alaa Nasser
Twenty Street
Al-Zubaidiyah Iraq 10001 +964 774 023 1025 salsabeel.alaa2204m@conursing.uobaghdad.edu.iq University of Baghdad,College of Nursing Iraq Consent to volunteer to participate in the study. Being between the ages of 6 and 12 years. Intravenous cannulation will be applied in right and left hand only. No difficulty in communication, including hearing, visual, speech, and language problems. Not receiving oral or parenteral analgesic treatment before administration. Not receiving chemotherapy treatment. 6 years 12 years Both Skin conditions such as burns, rashes, open wounds, abscess or boil, severe local infection or cellulitis at the intended insertion site. Peripheral vascular disease or compromised peripheral circulation at the intended insertion site (e. g. Peripheral neuropathy, diabetes, Peripheral artery disease, Raynaud's disease). Blood clotting disorders or increased risk of bleeding (e.g., hemophilia, thrombocytopenia). Anatomical abnormalities or restrictions that impede proper insertion or cause increased risk of complications. History of injections during the last 3 months. Treatment - Devices Intervention group: In the beginning, the patient’s consent is taken, and then a lottery is made to choose the intervention, either Shotblocker or ShotBlocker placebo, then a fill questionnaire, and then the intervention is performed by one of the methods, then the pain intensity is measured using Wong-Baker Faces pain scale. Control group: the intravenous cannulation is given using the traditional method, and then the pain intensity is measured using Wong-Baker Faces pain scale . Intravenous cannulation related pain (reducing). Timepoint: The patient's response after giving the intravenous cannulation directly to measure the intensity of pain. Method of measurement: Pain scale (Wong-Baker Faces) to measure the intensity of pain as a result of intravenous cannulation. The author of the trial is the funding source Approved 2023-11-22 Research Ethical Approval Committee, at the College of Nursing Twenty Street Al-Zubaidiyah Wasit Iraq Approved 2023-11-22 Research Ethical Approval Committee, at the College of Nursing Twenty Street Al-Zubaidiyah Wasit Iraq