The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty

Conditions
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Arthritis

Intervention / Treatment
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* Other: Live Music Therapy
* Other: Recorded Music Therapy
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Live Music Therapy<br>Live sedative guitar playing within a limited chord progression will be utilized. Added to this music will be vocal and verbal therapeutic suggestion for active listening, focused breathing, muscle relaxation, and guided imagery. Patients will choose from one of three nature scene options for the guided imagery in order to include patient preference of content. This treatment group will experience this music intervention live, including patient-centered interaction with the music therapist and education for repeated use of the routine on recording. | Other: Live Music Therapy<br>* 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).<br>|
| Active Comparator: Recorded Music Therapy<br>Recorded sedative guitar playing within a limited chord progression will be utilized. Added to this music will be vocal and verbal therapeutic suggestion for active listening, focused breathing, muscle relaxation, and guided imagery. Patients will choose from one of three nature scene options for the guided imagery in order to include patient preference of content. This treatment group will be given a recording of their chosen music relaxation routine for use throughout the study process. | Other: Recorded Music Therapy<br>* 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).<br>|
| Active Comparator: Control<br>This group will receive standard of care with no music therapy intervention | Other: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total shoulder arthroplasty, total shoulder replacement, adult, reverse shoulder arthroplasty