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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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ClinicalTrials.gov Identifier: NCT02692768
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2016
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
April Armstrong, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Arthritis Other: Live Music Therapy Other: Recorded Music Therapy Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Live Music Therapy
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
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).

Active Comparator: Recorded Music Therapy
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
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).

Active Comparator: Control
This group will receive standard of care with no music therapy intervention
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692768


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
April Armstrong
Investigators
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Principal Investigator: April D Armstrong, M.D. Milton S. Hershey Medical Center
Publications:
The Joint Commission. (2015). Facts about pain management. Retrieved from http://www.jointcommicssion.org/pain_management on 09.08.2015.
The Joint Commission. (2014). Clarification of the pain management standard. Joint Commission Perspectives, 34, 11, 11.
Dileo, C., Bradt, J. (2005). Medical music therapy: a meta-analysis & agenda for future research. Cherry Hill, NJ: Jeffrey Books.
What is music therapy? Retrieved from http://www.musictherapy.org/about/musictherapy/
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.
Bradt, J. (2010). The effects of music entrainment on postoperative pain perception in pediatric patients. Music and medicine, 2(3):150-57.
Cohen J. (1988) Statistical Power Analysis for the Behavioral Sciences (2nd ed). Lawrence Erlbaum Associates, Publisher

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Responsible Party: April Armstrong, Principal Investigator / Sponsor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02692768    
Other Study ID Numbers: STUDY00004093
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by April Armstrong, Milton S. Hershey Medical Center:
total shoulder arthroplasty
total shoulder replacement
adult
reverse shoulder arthroplasty
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases