Sequential Allocation Study of Music Duration

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

Detailed Description
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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.

Official Title
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Sequential Allocation Study of Music Duration

Conditions
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Anxiety, Patient Satisfaction, Music Exposure

Intervention / Treatment
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* Other: Music Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50 Elective scheduled cesarean delivery Able to provide informed consent Exclusion Criteria: Patient refusal Impaired hearing Patient taking at least one anti-anxiolytic medication on a daily basis at baseline No anxiety (a score of 0, on a scale of 0-10 of pre-music exposure anxiety) after consent is given.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Exposure<br>Patient will listen to a specified duration of music. | Other: Music Exposure<br>* Music will be played for participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety through a questionnaire rating anxiety levels on a scale of 0-10 | Investigators will measure the patient's anxiety pre exposure on a scale of 0-10, with 0 being no anxiety and 10 being extreme anxiety. Anxiety will be assessed again on the same scale post musical exposure. | baseline and up to 60 minutes after exposure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Musical Experience | The investigators will ask questions inquiring about the general musical experience for the patient in both the research context and their lives. The questions will include: Overall, how would you rate your experience listening to music pre-operation on a scale of 0-10, with 1 being the worst experience and 10 being the best experience? If you were to have another C-section, would you want to listen to music before hand? Definitely Not Maybe Not Maybe Yes Definitely Yes Would you recommend listening to music before a C-section to friends and family? Definitely Not Maybe Not Maybe Yes Definitely Yes Would you consider yourself as someone who listens to music regularly for enjoyment? Yes No What musical experience, if any, do you have? What level of education do you have in music? Are you currently active in music? | Up to 60 minutes after musical exposure | 
| Change in Heart Rate between baseline and at end of exposure | The investigators will measure the patient's heart rate before and after musical exposure | baseline and up to 60 minutes after exposure. | 
| Change in Blood Pressure between baseline and at the end of exposure | The investigators will measure the patient's blood pressure before and after musical exposure | baseline and up to 60 minutes after exposure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music, Anxiety,