The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthritis
- Sponsor
- April Armstrong
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Change from baseline in pain scores on the visual analog scale at 6 months
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to determine if music therapy interventions as adjunct to standard surgical care reduces pre- and post-operative pain and anxiety in patients undergoing total shoulder arthroplasty as compared with patients who receive standard of care without music therapy.
Detailed Description
This is a prospective, randomized, non-blinded clinical trial. The primary objective is to measure differences in pain and anxiety scores before and after music therapy interventions as compared to patients who do not receive music therapy.
Investigators
April Armstrong
Principal Investigator / Sponsor
Milton S. Hershey Medical Center
Eligibility Criteria
Inclusion Criteria
- •Age greater than or equal to 18 years of age
- •Body mass: 50-125 kg (inclusive )
- •Elective total or reverse total shoulder arthroplasty surgery by the study investigator
- •Gender: male or female (non-pregnant)
- •American Society of Anesthesiologists physical classification scale 1-3
- •Fluent in written and spoken English
- •Patients capable of giving informed consent
Exclusion Criteria
- •Age less than 18 years of age
- •Non-elective surgery by the study investigator
- •Pregnancy
- •American Society of Anesthesiologists physical classification scale 4-5
- •Non-English speaking persons
- •Diagnosis of cognitive disorder or musicogenic epilepsy
- •Pre-existing hearing problems, defined as inability to independently hear speech or music at average volume
- •Diagnosis of cognitive disorder including psychosis and dementia and/or musicogenic epilepsy
- •Anatomical abnormalities of the shoulder such as cancerous lesions or congenital defects
Outcomes
Primary Outcomes
Change from baseline in pain scores on the visual analog scale at 6 months
Time Frame: 6 months
Patients will be asked to return to the research site a total of six times (pre-operative, pre-surgery, post-surgery, recovery visit (12-24 hours after surgery), two-weeks post-operative visit, and 6 months post-operative visit). Pain scores will be recorded at each of these times.
Secondary Outcomes
- Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 6 months(6 months)