Arthritis
Conditions
Keywords
total shoulder arthroplasty, total shoulder replacement, adult, reverse shoulder arthroplasty
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.
Interventions
OTHERLive Music Therapy
Patients in this arm will meet with the music therapist to indicate preferences for one of three guided imagery scenarios to be included in their music-assisted relaxation routine. Patients will then receive live music relaxation and education for practice using a CD. Once admitted for surgery, patients will be seen immediately prior to going to the OR in the SDU, immediately following surgery in the PACU, and then within 12-24 hours of surgery on the inpatient floor. Pain and anxiety measures will be gathered at routine follow-up appointments following discharge (2 weeks and 6 months post-operatively).
Patients in this arm will meet with the music therapist to indicate preferences for one of three guided imagery scenarios to be included in their music-assisted relaxation routine. Patients will then receive explanation for using the recorded routine on CD. Once admitted for surgery, patients will be seen immediately prior to going to the OR in the SDU, immediately following surgery in the PACU, and then within 12-24 hours of surgery on the inpatient floor. Pain and anxiety measures will be gathered at routine follow-up appointments following discharge (2 weeks and 6 months post-operatively).
OTHERControl
Patients will receive standard of care without any music therapy intervention. These patients will have pain and anxiety measures taken at the same contact points as the music therapy intervention groups.
Sponsors
April Armstrong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain scores on the visual analog scale at 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 6 months | 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. |
Countries
United States
Outcome results
None listed