Here is the design of a clinical trial:

Official Title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty

Included conditions:
- Total Knee Arthroplasty

Study Armgroups:
- {'label': 'Immersive VR group', 'type': 'EXPERIMENTAL', 'description': 'Patients in the Immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface.\n\nTo reduce the influence of the anesthesia provider on the determination of sedative requirements, patients will administer their own sedation according to their needs for relaxation and comfort using a patient controlled system.', 'interventionNames': ['Other: Virtual Reality Immersive Relaxation']}
- {'label': 'Music group', 'type': 'ACTIVE_COMPARATOR', 'description': "Patients randomized to the Music group will be equipped with VR headsets but won't view any content. They will also be equipped with noise cancelling headphones in the same fashion as the immersive VR group. A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient. Patients in the Sham VR group will also use patient controlled sedation.", 'interventionNames': ['Other: Immersive Audio Experience']}
- {'label': 'Sham VR + Usual Care Control Group', 'type': 'SHAM_COMPARATOR', 'description': 'Subjects in the control group will wear VR headsets and headphones but will not view any content or listen to any audible content. They will undergo Monitored Anesthesia Care (MAC) according to a prespecified protocol targeting light or moderate sedation with a propofol infusion.', 'interventionNames': ['Other: Sham Virtual Reality Experience']}

Interventions:
- {'type': 'OTHER', 'name': 'Virtual Reality Immersive Relaxation', 'description': 'The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.', 'armGroupLabels': ['Immersive VR group']}
- {'type': 'OTHER', 'name': 'Immersive Audio Experience', 'description': 'A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.', 'armGroupLabels': ['Music group']}
- {'type': 'OTHER', 'name': 'Sham Virtual Reality Experience', 'description': 'Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.', 'armGroupLabels': ['Sham VR + Usual Care Control Group']}

Primary Outcomes:
- {'measure': 'Intraoperative Propofol Dose', 'description': 'Total propofol dose (mg/kg/min) administered intraoperatively', 'timeFrame': 'Duration of the procedure, on average 1 to 3 hours'}

Please estimate the sample size based on the assumption: 
A two-sided t-test with a significance level of 0.025 and 90% power is used for the VR vs. control group comparison. For the VR vs. music group comparison, a two-sided t-test with a significance level of 0.025 and 67% power is used. The estimated mean propofol dose in the control group is 155 (±45) mg h−1. To account for dropout and better estimate secondary outcomes, additional patients will be enrolled, increasing the power of the last hypothesis test to 76%.
Sample size {14}
        The analysis involves two simultaneous comparisons: (1) comparing the VR group to the control group and (2) comparing the VR group to the music group. Data will be analyzed using the Bonferroni correction procedure for multiple comparisons. This is the first trial in the United States to use virtual reality for joint replacement, so no prior data exists to allow us to estimate the anticipated effect size. Therefore, we based our assumptions on clinical judgment. We believe a 33% reduction in propofol dose is clinically significant when comparing the VR to the control group. We will use G*Power 3.1.9.7. to calculate sample size, with a two-sided t-test with a significance level of 0.025, 90% power, and an estimated mean propofol dose of 155 (Â±â45) mg hâ1 in the control group for a sample size of 42 patients in the intervention group and 14 in the control group. Comparing the VR and music groups, a two-sided t-test with a significance level of 0.025, 42 participants per group, with an anticipated 12% decrease of propofol dose in the VR group, we will have 67% power to reject the null hypothesis. To compensate for anticipated dropout and to better estimate infrequent but important secondary outcomes including delirium, we will plan to enroll additional patients to bring the total planned enrollment in each group to 50:50:25, for a total of 125 patients. Accordingly, the power of our last hypothesis test will increase to 76%. Finally, during the pilot phase, six patients will be enrolled. Their data will not contribute to the primary outcome analysis. Thus, this study plans to enroll a total sample of 131 patients.