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

Not Applicable

Completed

• Conditions: Arthritis

• Registration Number: NCT02692768
• Lead Sponsor: April Armstrong

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.

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-02-26
• Study Start: 2016-03
• Status Verified: 2022-09
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States