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

A

April Armstrong

Status

Completed

Conditions

Arthritis

Treatments

Other: Recorded Music Therapy
Other: Live Music Therapy
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT02692768
STUDY00004093

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 3 patient groups

Live Music Therapy
Active Comparator group
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.
Treatment:
Other: Live Music Therapy
Recorded Music Therapy
Active Comparator group
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.
Treatment:
Other: Recorded Music Therapy
Control
Active Comparator group
Description:
This group will receive standard of care with no music therapy intervention
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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