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IRCT20221223056900N1 IRCT 2023-01-01 University of Baghdad Effect of Shot blocker and Cold Spray on Venipuncture Pain among Blood Donors: A Randomised Controlled Trial Effect of Shot blocker and Cold Spray on Venipuncture Pain among Blood Donors: A Randomised Controlled Trial 2023-01-10 anticipated 300 Complete https://irct.ir/trial/67573 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In order to maintain a transparent and scientific-base randomization process, systematic sampling methods be used in assigning participants (individuals: blood donors), to intervention (shotblocker or cold spray) and control group, assuming that each participant has an equal chance of being assigned to any group. firstly, defined will the target population, Then. estimate the sampling interval, is calculated by dividing the population size (1500) by the desired sample size (300) with a fixed periodic interval (5) that considers the starting point. N/A Blood donation required venipuncture performed by inserting a large bore needle (16G or 18G) into a peripheral vein, usually within the antecubital fossa (Myers & Collins ,2022), also Blood donation is one of the most frequent reasons for venipuncture, which is also one of the most frequent invasive medical procedures in general (Simundic et al.,2015) .Venepuncture-related complications can include the pain, development of haematomas, nerve damage, arterial puncture, petechiae, allergies, phobia, infections, fainting , haemorrhaging, and thromboembolism (Buowari,2013). Tee, (2015) stated that venipuncture often performed by nurses, which cause pain to patients. also, other study reported blood donors who undergo venipuncture frequently feel stress and extreme pain (Ialongo & Bernardini, 2016). Pain is an uncomfortable emotion and a physical sensation that might indicate either real or potential tissue injury and Pain not only results from disease itself but may also be derived from invasive diagnosis and treatment interventions (Aydede ,2019). Pain caused by venipuncture become problematic (Shafii et al.,2019), causing high levels of anxiety (McMurtry et al.,2015) and emotional consequences including needle-related phobia (Sokolowski et al.,2010). Therefore, it is essential to control pain throughout medical procedure (Marcy et al., 2017), and it is the primary responsibility of nurses to use the most effective methods to manage pain (Blinderman,2016).. Intervention 1: Intervention group 1: Use shotblocker on skin blood donors during venipuncture and immediately after venipuncture assesses the severity of pain by visual analogue scale . Intervention group 2 : Use cold spray on skin blood donors during venipuncture and immediately after venipuncture to assess pain severity by visual analogue scale. Intervention 2: Control group: For the control group, no intervention will be done (usual care), and assess pain immediately after venipuncture. Yes - There is a plan to make this available What will be shared: The data will be the results of the questionnaire that contains from two-part, the first part is demographic characteristics and the second part is a visual analogue scale to measure blood donors' pain related to venipuncture in both control and intervention groups. When: 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 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. His email is Ali.Hussein2102m@conursing.uobaghdad.edu.iq. How to obtain: Users can ask for the data and permission via email. His email is Ali.Hussein2102m@conursing.uobaghdad.edu.iq. Comments:
public Ali Abdalreda Hussien
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Baqubah Iraq 32001 +964 770 075 2984 Ali.Hussein2102m@conursing.uobaghdad.edu.iq University of Baghdad scientific Ali Abdalreda Hussein
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Baqubah Iraq 32001 +964 770 075 2984 Ali.Hussein2102m@conursing.uobaghdad.edu.iq University of Baghdad Iraq Subjects eligible for inclusion whom male and female adult blood donors (18 years and above). Volunteering to participate in the study and giving a written consent form Read and write There was no sign of (pain, hematoma, necrosis, scar, incision, or infection) on the skin around the venipuncture site, and no analgesic drug for the last six hours. 18 years 65 years Both They were excluded if they refused participation significantly impaired vision altered mental state suffered from skin disease associated with cold intolerance (e.g. Raynaud’s disease) had vision and hearing problems sensory-motor deficit, diabetes, peripheral vascular disease, neuropathy, Wound, burn, scar tissue, etc. on the skin around the venipuncture site. Other Other Intervention group 1: Use shotblocker on skin blood donors during venipuncture and immediately after venipuncture assesses the severity of pain by visual analogue scale . Intervention group 2 : Use cold spray on skin blood donors during venipuncture and immediately after venipuncture to assess pain severity by visual analogue scale. Control group: For the control group, no intervention will be done (usual care), and assess pain immediately after venipuncture. The primary outcome variable is the pain related to Venipuncture in blood donors that can be changed based on shotblocker or cold spray. Timepoint: Immediately after applying a shotblocker or cold pray, pain related to venipuncture measuring by a visual analogue scale. Method of measurement: The visual analogue scale (VAS) will be used to assess the level of pain related to venipuncture. University of Baghdad Approved 2022-11-27 Ethics committee in college of Nursing at university of Baghdad No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town, Baqubaha Dialya Iraq