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CLINICAL TRIAL PROTOCOLRandomized, prospective, sham controlled, blinded, crossover clinical study of the effect of the virtual reality (VR) technology on recovery of the indicators of the autonomic
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To fill out a randomized prospective sham-controlled blinded study, follow these steps: 1. Define the research question and study objectives. 2. Design the study protocol, including the eligibility criteria and randomization process. 3. Recruit participants who meet the eligibility criteria. 4. Randomly assign participants to either the treatment group or the control group, using a sham intervention for blinding purposes. 5. Implement the study interventions according to the assigned groups. 6. Collect and record data from the participants during the study period. 7. Analyze the data using appropriate statistical methods. 8. Interpret the results and draw conclusions from the study findings. 9. Prepare a report or manuscript detailing the study design, methodology, results, and discussion.

Who needs randomized prospective sham-controlled blinded?

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Randomized prospective sham-controlled blinded studies are primarily needed in the field of clinical research. They are commonly used to evaluate the efficacy and safety of new medical interventions or treatments. Researchers, pharmaceutical companies, regulatory authorities, and healthcare professionals may need such studies to assess the effectiveness of interventions, compare different treatments, and make evidence-based decisions regarding patient care and treatment protocols.
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Randomized prospective sham-controlled blinded refers to a type of clinical trial design where participants are randomly assigned to either a treatment group or a sham (placebo) group. The trial is conducted prospectively, meaning data is collected moving forward in time. The term 'blinded' indicates that neither the participants nor the researchers know which group the participants belong to, minimizing bias.
Researchers and institutions conducting clinical trials that meet regulatory requirements for randomized prospective sham-controlled studies are required to file relevant documentation.
To fill out a randomized prospective sham-controlled blinded submission, researchers must complete required forms detailing the study design, objectives, methodology, and participant information as specified by regulatory guidelines.
The purpose is to evaluate the efficacy and safety of a treatment by comparing it against a placebo while eliminating bias through randomization and blinding, thus providing robust and reliable results.
Information required typically includes study design details, objectives, participant demographics, methodology, outcome measures, statistical analysis plans, and ethical considerations.
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