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IRCT20240413061475N1 IRCT 2024-07-14 Sabzevar University of Medical Sciences Comparison of the effect of Acupressure and Buzzy on First insertion success and pain related insertion of intravenous catheter (Angiocath) Comparison of the effect of Acupressure and Buzzy on First insertion success and pain related insertion of intravenous catheter (Angiocath) in 3-6 year old children referred to the emergency department 2024-08-22 anticipated 84 Complete https://irct.ir/trial/77779 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Convenience sampling will be used for this study. This means that any individual who enters the treatment center and meets the study's inclusion criteria will be eligible to participate. With a sample size of 84, we aim to recruit 28 participants in each group. We also intend to ensure an equal distribution of girls and boys in each experimental group. Therefore, we will employ a blocked randomization method. We will use blocks of 12 participants each, assigning 4 to the Buzzy group, 4 to the Acupressure group, and 4 to the Control group. There will be three blocks of 12 for girls and three blocks of 12 for boys. Additionally, we will use two additional blocks of 6 to enroll an additional 12 girls and boys. In each block of 6, 2 participants will be assigned to the Acupressure group, 2 to the Buzzy group, and 2 to the Control group. Random allocation will be conducted using the "Random Allocation Software". Each child who comes to the clinic for angiocatheter placement and meets the study's inclusion criteria will be placed in one of these blocks based on gender and will be randomly assigned to one of the interventions From the start of the vascular access process and angiocatheter placement, the research assistant measures the time to vascular access using a stopwatch and records it along with the number of attempts to access the vessels in the clinical data collection checklist. Simultaneously, by carefully observing the child, the assistant enters scores for facial expression, leg movement, activity level, crying, and consolability to assess the pain score in the aforementioned checklist. All interventions are performed outside the venipuncture room and the research assistant is blinded to the type of intervention performed. N/A Condition 1: pain related insertion of intravenous catheter (Angiocath). Condition 2: first insertion success of intravenous catheter (Angiocath). Intervention 1: Intervention group:The first intervention group : Acupressure. Intervention 2: Intervention group:The second intervention group: buzzy. Intervention 3: Control group: Control group. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The start of the access period after the publication of the article To whom: All people Conditions: The data can be used with the permission of Dr. Ali Asghar Jesemi Marghzar. Where to obtain: Send an email to Dr. Ali Asghar Jesemi Marghzar Email address: jesmiaa@gmail.com How to obtain: By sending an email to Dr. Ali Asghar Jasemi Marghzar after his approval, the data will be provided to the individual. Comments:
public Ali Asghar Jesmi Marghzar
Sabzevar, Shohadaye Hasteiee Boulevard, Sabzevar University of Medical Science
sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 1300 jesmiaa@gmail.com Sabzevar University of Medical Sciences scientific Ali Asghar Jesmi Marghzar
Sabzevar, Shohadaye Hasteiee Boulevard, Sabzevar University of Medical Science
sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 1300 jesmiaa@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) There is a need and a doctor's order to insert the IV catheter The child is 3 to 6 years of age Parents have given informed consent. This is the child's first IV catheterization experience at this case of admission The child is fully alert The child does not have acute or chronic pain, and the child's FLACC pain scale score is zero upon admission 3 years 6 years Both IV catheter to be inserted in a place other than the back of the hand Usage of sedatives or topical or oral pain relievers within 48 hours before insertion There is bruising, inflammation, wound or fracture near the IV catheterization place or the massage point. The child has a history of chemotherapy and dialysis. The child has cognitive disorders. Specific medical conditions: (blood disorders, thyroid disorders, epilepsy, peripheral vascular disease, diabetes, peripheral neuropathy, edema, blood diseases, mental health problems, hearing and vision problems, motor problems in the lower extremities) Hearing and vision impairments Inability to communicate verbally Intellectual disability or cerebral palsy Diagnosed mental health problem Rehabilitation Rehabilitation N/A Intervention group:The first intervention group : Acupressure Intervention group:The second intervention group: buzzy Control group: Control group FLACC instrument pain score. Timepoint: During the intervention. Method of measurement: FLACC instrument pain score(faces, legs, activity, cry, consolability ). Number of successful angiocath placement attempts. Timepoint: During the intervention. Method of measurement: Counting the number of times of angiocath placement. Time of successful angiocath placement attempts. Timepoint: During the intervention. Method of measurement: stopwatch. Sabzevar University of Medical Sciences Approved 2024-07-06 Ethics committees of Sabzevar University of Medical Sciences Sohadaye hastei boulevard - Sabzevar university of medical Sciences Campus sabzevar Razavi Khorasan Iran (Islamic Republic of)