Arthritis Clinical Trial
Official title:
The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
Verified date | September 2022 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | September 13, 2022 |
Est. primary completion date | September 13, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
April Armstrong |
United States,
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Cohen J. (1988) Statistical Power Analysis for the Behavioral Sciences (2nd ed). Lawrence Erlbaum Associates, Publisher
Dileo, C., Bradt, J. (2005). Medical music therapy: a meta-analysis & agenda for future research. Cherry Hill, NJ: Jeffrey Books.
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Levy JC, Everding NG, Gil CC Jr, Stephens S, Giveans MR. Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Dec;23(12):1872-1881. doi: 10.1016/j.jse.2014.04.014. Epub 2014 Jun 26. — View Citation
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Rafer L, Austin F, Frey J, Mulvey C, Vaida S, Prozesky J. Effects of jazz on postoperative pain and stress in patients undergoing elective hysterectomy. Adv Mind Body Med. 2015 Winter;29(1):6-11. — View Citation
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The Joint Commission. (2014). Clarification of the pain management standard. Joint Commission Perspectives, 34, 11, 11.
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What is music therapy? Retrieved from http://www.musictherapy.org/about/musictherapy/
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in pain scores on the visual analog scale at 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. | 6 months | |
Secondary | Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 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). Anxiety scores will be recorded at each of these times. | 6 months |
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