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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02692768
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	April Armstrong
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	April D Armstrong, M.D.
Principal Investigator Affiliation	Milton S. Hershey Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Active Comparator: Control

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

Interventions

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).

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).

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hershey, Pennsylvania

Status

Address

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

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