Clinical trial NCT02692768: The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
Official title: The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: total shoulder arthroplasty
total shoulder replacement
adult
reverse shoulder arthroplasty
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in pain scores on the visual analog scale at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: April D Armstrong, M.D.
role: PRINCIPAL_INVESTIGATOR
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