Get the free Open-label Randomized Controlled Trial to Assess Preoperative Acupuncture

This document outlines a prospective, open-label, randomized controlled trial designed to evaluate the efficacy and safety of preoperative acupuncture for reducing preoperative anxiety and postoperative pain in high-anxiety patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) at the Bone-and-Joint Institute at Hartford Hospital. The study aims to demonstrate how acupuncture can improve surgical outcomes and patient satisfaction while potentially decreasing opioid...

How to fill out open-label randomized controlled trial

How to fill out open-label randomized controlled trial

1. Define the objectives of the trial.
2. Select a suitable study population and set inclusion/exclusion criteria.
3. Randomly assign participants to different treatment groups without blinding.
4. Prepare and provide the intervention(s) to participants.
5. Ensure all ethical approvals and informed consent are obtained.
6. Collect data on outcomes as per the predefined study protocol.
7. Analyze the data using appropriate statistical methods.
8. Report the findings in accordance with clinical trial reporting guidelines.

Who needs open-label randomized controlled trial?

1. Researchers studying the effectiveness of a treatment where participant awareness of the treatment is necessary.
2. Clinical trial sponsors looking to assess direct patient responses to treatments.
3. Healthcare providers interested in real-world efficacy of treatments.
4. Regulatory bodies evaluating the safety and effectiveness of new therapies.

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What is open-label randomized controlled trial?

An open-label randomized controlled trial is a type of clinical study where participants are randomly assigned to different treatment groups, and both the researchers and participants are aware of the treatment assignments. This design is often used to assess the effectiveness and safety of new interventions.

Who is required to file open-label randomized controlled trial?

Researchers and organizations conducting clinical trials involving human subjects, particularly those seeking regulatory approval for new treatments or drugs, are required to file open-label randomized controlled trials.

How to fill out open-label randomized controlled trial?

Filling out an open-label randomized controlled trial typically involves submitting a detailed protocol that includes study objectives, design, methodology, participant selection criteria, and ethical considerations to an institutional review board or regulatory authority.

What is the purpose of open-label randomized controlled trial?

The purpose of an open-label randomized controlled trial is to evaluate the effectiveness, safety, and tolerability of a new treatment or intervention under conditions where both participants and researchers know the treatment being administered.

What information must be reported on open-label randomized controlled trial?

Key information that must be reported includes the study design, randomization method, participant enrollment statistics, treatment details, primary and secondary outcomes, and any adverse events observed during the trial.