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

NCT02692768 | Completed

• 1 other identifier: STUDY00004093
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis

Keywords

total shoulder arthroplasty; total shoulder replacement; adult; reverse shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (3)

Live Music Therapy

ACTIVE COMPARATOR

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

Recorded Music Therapy

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

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).

Live Music Therapy

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).

Recorded Music Therapy

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• April Armstrong: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (19)

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  PMID: 24981553 BACKGROUND

• The Joint Commission. (2015). Facts about pain management. Retrieved from http://www.jointcommicssion.org/pain_management on 09.08.2015.

  BACKGROUND

• The Joint Commission. (2014). Clarification of the pain management standard. Joint Commission Perspectives, 34, 11, 11.

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  PMID: 11587109 BACKGROUND

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  PMID: 25607117 BACKGROUND

• Dileo, C., Bradt, J. (2005). Medical music therapy: a meta-analysis & agenda for future research. Cherry Hill, NJ: Jeffrey Books.

  BACKGROUND

• Cepeda MS, Carr DB, Lau J, Alvarez H. WITHDRAWN: Music for pain relief. Cochrane Database Syst Rev. 2013 Oct 25;2013(10):CD004843. doi: 10.1002/14651858.CD004843.pub3.

  PMID: 24163271 BACKGROUND

• What is music therapy? Retrieved from http://www.musictherapy.org/about/musictherapy/

  BACKGROUND

• Tan X, Yowler CJ, Super DM, Fratianne RB. The Interplay of Preference, Familiarity and Psychophysical Properties in Defining Relaxation Music. J Music Ther. 2012 Summer;49(2):150-79. doi: 10.1093/jmt/49.2.150.

  PMID: 26753216 BACKGROUND

• Robb, S., Nichols, R., Rutan, R., Bishop, B., & Parker, J. (1995). The effects of music assisted relaxation on perioperative anxiety. Journal of Music Therapy, 32, 2-21.

  BACKGROUND

• Stouffer JW, Shirk BJ, Polomano RC. Practice guidelines for music interventions with hospitalized pediatric patients. J Pediatr Nurs. 2007 Dec;22(6):448-56. doi: 10.1016/j.pedn.2007.04.011.

  PMID: 18036465 BACKGROUND

• Modesti PA, Ferrari A, Bazzini C, Costanzo G, Simonetti I, Taddei S, Biggeri A, Parati G, Gensini GF, Sirigatti S. Psychological predictors of the antihypertensive effects of music-guided slow breathing. J Hypertens. 2010 May;28(5):1097-103. doi: 10.1097/HJH.0b013e3283362762.

  PMID: 20160655 BACKGROUND

• Madson AT, Silverman MJ. The effect of music therapy on relaxation, anxiety, pain perception, and nausea in adult solid organ transplant patients. J Music Ther. 2010 Fall;47(3):220-32. doi: 10.1093/jmt/47.3.220.

  PMID: 21275333 BACKGROUND

• Kleiber C, Adamek MS. Adolescents' perceptions of music therapy following spinal fusion surgery. J Clin Nurs. 2013 Feb;22(3-4):414-22. doi: 10.1111/j.1365-2702.2012.04248.x. Epub 2012 Sep 18.

  PMID: 22985428 BACKGROUND

• Chi GC, Young A. Selection of music for inducing relaxation and alleviating pain: literature review. Holist Nurs Pract. 2011 May-Jun;25(3):127-35. doi: 10.1097/HNP.0b013e3182157c64.

  PMID: 21508712 BACKGROUND

• Bradt, J. (2010). The effects of music entrainment on postoperative pain perception in pediatric patients. Music and medicine, 2(3):150-57.

  BACKGROUND

• Mitchell LA, MacDonald RA. An experimental investigation of the effects of preferred and relaxing music listening on pain perception. J Music Ther. 2006 Winter;43(4):295-316. doi: 10.1093/jmt/43.4.295.

  PMID: 17348757 BACKGROUND

• Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.

  PMID: 21697139 BACKGROUND

• Cohen J. (1988) Statistical Power Analysis for the Behavioral Sciences (2nd ed). Lawrence Erlbaum Associates, Publisher

  BACKGROUND

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• April D Armstrong, M.D.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator / Sponsor

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: March 1, 2016
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)