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

Primary Purpose

Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Live Music Therapy
Recorded Music Therapy
Control
Sponsored by
April Armstrong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring total shoulder arthroplasty, total shoulder replacement, adult, reverse shoulder arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Live Music Therapy

Recorded Music Therapy

Control

Arm Description

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.

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.

This group will receive standard of care with no music therapy intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 23, 2016
Last Updated
September 13, 2022
Sponsor
April Armstrong
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1. Study Identification

Unique Protocol Identification Number
NCT02692768
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
April Armstrong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
total shoulder arthroplasty, total shoulder replacement, adult, reverse shoulder arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Live Music Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Recorded Music Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will receive standard of care with no music therapy intervention
Intervention Type
Other
Intervention Name(s)
Live Music Therapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Recorded Music Therapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in pain scores on the visual analog scale at 6 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 6 months
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April D Armstrong, M.D.
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty

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