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IRCT20240511061742N1 IRCT 2024-06-27 College of Nursing, University of Baghdad Reducing Pain Associated with Intravenous Cannulation in School Age Children Buzzy Device Versus Distraction Cards in Reducing Peripheral Intravenous Cannulation Related-Pain Among School Age Children: A Comparative Randomized Controlled Trial 2024-07-01 anticipated 192 Complete https://irct.ir/trial/76794 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using the lottery method, which is considered one of the oldest and most ancient methods of selecting a sample randomly, the sample was selected for the study. The names of the three groups were written separately on scraps of paper with a number from 1-64 written on them for each of the three groups and placed inside a container. Then the participating child himself draws a paper from the container containing the name of one of the groups and a serial number from 1-64. The paper is not returned to the container after it is selected. N/A Pain management related intravenous cannulation. Intervention 1: After obtaining the patient's consent and explaining the device's operation to him, the device is applied one minute before insertion of the IV cannula over the place where the cannula will be formed, with the cooling wings placed under the device. Then the device is turned on while it is tied to the patient's hand before insertion of the IV cannula. After one minute, the nurse assisting the researcher forms the cannula. After completing the procedure, the researcher turns off the device and removes it from the child's hand. Then the researcher measures the pain level with the Wong-Baker Faces pain scale. Intervention 2: Control group: The intravenous catheter was given using the (standard procedure) followed in the hospital without any intervention or application of any other method by the researcher, only the emergency nurse performed the standard procedure followed, and then the pain intensity was measured using the Wong-Baker pain faces scale by the researcher. Intervention 3: The purpose of the study is explained in a simple way to the child’s parents and to the child as well, and then the distraction card is shown to the child by the researcher before starting to insert the intravenous cannula, and the child is asked about the details on the distraction card (differences or puzzles). While the child is busy concentrating on the distraction card, the intravenous cannula is inserted by the specialist nurse. After completion, the pain level is measured. 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: mohammed.ata2204p@conursing.uobaghdad.edu.iq How to obtain: N/A Comments: The IRCT members deserve sincere gratitude for their sincere efforts to support researchers in achieving their academic goals.
public Mohammed Ataallah Ahmed
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Mosul Iraq 41001 +964 770 744 4568 mohammed.ata2204p@conursing.uobaghdad.edu.iq University of Baghdad, College of Nursing scientific Mohammed Ataallah Ahmed
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Mosul Iraq 41001 +964 770 744 4568 mohammed.ata2204p@conursing.uobaghdad.edu.iq University of Baghdad, Collège 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 IV injections during the last 3 months. Treatment - Devices N/A Prevention After obtaining the patient's consent and explaining the device's operation to him, the device is applied one minute before insertion of the IV cannula over the place where the cannula will be formed, with the cooling wings placed under the device. Then the device is turned on while it is tied to the patient's hand before insertion of the IV cannula. After one minute, the nurse assisting the researcher forms the cannula. After completing the procedure, the researcher turns off the device and removes it from the child's hand. Then the researcher measures the pain level with the Wong-Baker Faces pain scale. Control group: The intravenous catheter was given using the (standard procedure) followed in the hospital without any intervention or application of any other method by the researcher, only the emergency nurse performed the standard procedure followed, and then the pain intensity was measured using the Wong-Baker pain faces scale by the researcher. The purpose of the study is explained in a simple way to the child’s parents and to the child as well, and then the distraction card is shown to the child by the researcher before starting to insert the intravenous cannula, and the child is asked about the details on the distraction card (differences or puzzles). While the child is busy concentrating on the distraction card, the intravenous cannula is inserted by the specialist nurse. After completion, the pain level is measured Intravenous cannulation related pain (reducing). Timepoint: The patient's response is measured immediately after the intravenous cannulation to measure the intensity of pain only once. Method of measurement: Pain scale (Wong-Baker Faces) to measure the intensity of pain as a result of intravenous cannulation intravenous cannulation. The author of the trial is the funding source Approved 2024-04-25 Research Ethical Approval Committee, at the College of Nursing Nirgal St. Al-Mosul Nirgal Iraq