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Two nurse researchers are interested in studying whether a pain assessment tool for critical care patients...

Two nurse researchers are interested in studying whether a pain assessment tool for critical care patients is valid and reliable when applied to a group of patients who cannot communicate verbally due to mechanical ventilation. They design a validation study in which randomly selected patients will be assessed using the tool after a painful procedure (tracheal suctioning) and after a nonpainful procedure (oral care). If patient responses result in higher scores after the painful procedure than after the nonpainful one, then the researchers will conclude that the tool is effective for these patients in differentiating pain responses from responses to nursing procedures in general.

Using the checklist in the text, discuss and draw a conclusion as to whether this study will likely be exempt, expedited, or full review. Would the study be considered ethical? Explain your rationale.

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Nurses play a important role in pain assessment..patient in ICU with mechanical ventilator have low level of consciousness,sedation without verbal communication they point out their pain with fingers or shaking their heads..staff nurse in ICU usually unaware of patient pain when they are in ventilator.prolonged pain can affect their endocrine,cardiovascular,immune,musculoskeletal system and nervous system..it result with chronic pain syndrome and lot of complications..using psychometric properties of Behavioral pain scale(BPS) and Critical care pain observational tool(CPAT) in ICU patient found strongest valid and reliable pain assessment scale..it includes three common parameters like facial expression,body movement and ventilator compliance..in ICU suctioning is the usual procedure to clear secretion and improve air way..
In this study randomly selected patients for pain assessment using painful procedure must have ethical considerations..it need ethics approval consent to participate..Families should be aware of procedure that must have confidentiality of data..Get informed consent after having all their questions answered..The consent form should include the purpose of the study, and significance..Signed consent form are the eligibility form.. procedure should be performed by the trained research assistant or well experience nurse in critical care unit and pain management expert..

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