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

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692768
• Other study ID #: STUDY00004093
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 13, 2022

Study information

• Verified date: September 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis

Intervention

Other:
• Live Music Therapy
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
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
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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
April Armstrong

Country where clinical trial is conducted

United States, 

References & Publications (19)

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

Cepeda MS, Carr DB, Lau J, Alvarez H. WITHDRAWN: Music for pain relief.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

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. Review. — View Citation

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

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

Epker J, Block AR. Presurgical psychological screening in back pain patients: a review. Clin J Pain. 2001 Sep;17(3):200-5. Review. — View Citation

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. — View Citation

Levy JC, Everding NG, Gil CC Jr, Stephens S, Giveans MR. Speed of recovery after shoulder arthroplasty: a comparison of reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2014 Dec;23(12):1872-1881. doi: 10.1016/j.jse.2014.04.014. Epub 2014 Jun 26. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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®): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21. — View Citation

Rafer L, Austin F, Frey J, Mulvey C, Vaida S, Prozesky J. Effects of jazz on postoperative pain and stress in patients undergoing elective hysterectomy. Adv Mind Body Med. 2015 Winter;29(1):6-11. — View Citation

Robb SL. Music assisted progressive muscle relaxation, progressive muscle relaxation, music listening, and silence: a comparison of relaxation techniques. J Music Ther. 2000 Spring;37(1):2-21. — View Citation

Stouffer JW, Shirk BJ, Polomano RC. Practice guidelines for music interventions with hospitalized pediatric patients. J Pediatr Nurs. 2007 Dec;22(6):448-56. Review. — View Citation

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. — View Citation

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

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

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

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 months