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Completed

NCT Number: NCT02692768

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

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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Live Music Therapy

Other

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).

Recorded Music Therapy

Other

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).

Control

Other

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 outcomes

  1. Change from baseline in pain scores on the visual analog scale at 6 months

    Time frame: 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 outcomes

  1. Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

April Armstrong

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2016
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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