Pilot Study to Identify the Impact of OnabotulinumtoxinA (BOTOX®) on Patient Perceived Stress.
The purpose of this prospective single-center, blinded*, randomized, proof-of-concept study is to determine whether OnabotulinumtoxinA (BOTOX®) injections will change the level of stress perceived by generally healthy adult female participants. It is hypothesized that BOTOX® injections will be associated with decreases in perceived stress levels, measured by scores on the Perceived Stress Scale (PSS) questionnaire. The primary outcome measure is a chronological decrease in PSS scores between any two points of the study period.
Comparison of the placebo- and BOTOX®-treated participant scores will either support or disprove the study hypothesis.
Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment.
The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve:
* vital signs and Body Mass Index (BMI) measurements
* basic/interval history and physical
* 2 Perceived Stress Scale (PSS) questionnaires
* injection of 64 units of either BOTOX® or sterile salt solution
* stay for 60-minutes after treatment for monitoring and to complete study tasks
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