Sequential Allocation Study of Music Duration
Condition: Anxiety; Patient Satisfaction; Music Exposure
Study type: Interventional

Summary: 
      The investigators are interested in studying the effects of varying lengths of musical
      exposure on patient anxiety and stress levels.
    

Detailed description: 
      Studies have shown that musical intervention has had an effect on hemodynamic variability,
      postoperative pain and the amount of sedative and analgesic medication needed during
      post-operative periods. These effects extend to beyond post-operative care as musical
      intervention has played a role in pain management for cancer and for the side-effects of
      cancer treatment. However, little information is known whether or not the duration of musical
      exposure plays a direct role in the efficacy of reducing pain, sedative use and other
      unwanted side effects during post-operative recovery. Similarly, it is not known if
      "under-exposure" and "over-exposure" states exist in musical intervention when it comes
      specifically to patient anxiety before and after operations.

      The investigators believe there to be an optimal duration of music exposure (ED50) that will
      have the highest probability of achieving the desired effects of reduced anxiety. In
      understanding the ED50 of musical exposure, there could be various applications that work in
      tandem with other therapies to reduce patient pain and anxiety in medical settings. While the
      investigators do not expect music to be as effective as medical intervention, it holds a
      promising position as a form of supportive therapy.

      The study will utilize a sequential allocation approach where subsequent parameters of the
      study are adjusted based on the accrued data. The sequential allocation method minimizes the
      necessary sample size while still providing accurate effective dose (ED50) measurements. Our
      allocation methods will follow an up-and-down sequential allocation model. Our targeted
      population will be patients awaiting scheduled cesarean sections. This patient population was
      chosen based on a previous study done on patient satisfaction in response to musical
      exposure. Patient accessibility was also a considered factor. Scheduled cesarean section
      patients will usually have access to their own room during pre-operative preparation, lending
      an ideal environment to conduct the musical exposure in.

      Specifically, the study team will start at a musical exposure of 15 minutes for the first
      study subject. The second study subject will have their exposure time "stepped up" by 5
      minutes if the first study subject results in a success, defined as a greater than one point
      reduction in anxiety before and after musical exposure. If there was no change or worsening
      of anxiety in the first study subject, then the second subject will have their exposure time
      reduced by 5 minutes. This will continue until the first 5 minute exposure is achieved. At
      that point, success and failures will increase and decrease the exposure time by increments
      of 1 minute. The minimal musical exposure time will be set at 1 minute and if the effective
      dose is achieved at 1 minute, the study team will start each subsequent patient at 1 minute
      of musical exposure. The patients will all listen to Mozart music played for them from some
      type of music player. The study will terminate once the data shows 6 "cross overs" between up
      and down steps or if 30 participants have been recruited-whichever comes first. Statistical
      analysis and final ED50 determination will be done using methods described by Dixon and
      Massey.
    

Intervention name(s): Music Exposure
Intervention type(s): Other
Intervention description(s): Music will be played for participants.
Intervention model: Single Group Assignment
Intervention model description: The investigators will use a sequential allocation approach where subsequent parameters of the study are adjusted based on the accrued data. Allocation methods will follow an up and down model, where patients musical exposure time will be determined based on the success or failure of the patient immediately preceding them.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Music, Anxiety,