ArthritisNCT02692768
The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
A study testing Live Music Therapy and Recorded Music Therapy in people with Arthritis, run by April Armstrong at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Live Music Therapy and Recorded Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Conditions
- Arthritis
- Being tested
- Live Music Therapy, Recorded Music Therapy, Control
- Keywords
- total shoulder arthroplasty, total shoulder replacement, adult, reverse shoulder arthroplasty
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Music TherapyOther
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 TherapyOther
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).
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Recorded Music Therapy |
| Control | Active comparator | This group will receive standard of care with no music therapy intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- April Armstrong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, April Armstrong, Milton S. Hershey Medical Center
- Investigators
- April D Armstrong, M.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692768
- Sponsor's protocol ID
- STUDY00004093
- Status last verified
- Sep 2024
- First submitted
- 23 Feb 2016
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24981553The 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.
Epker J, Block AR. Presurgical psychological screening in back pain patients: a review. Clin J Pain. 2001 Sep;17(3):200-5. doi: 10.1097/00002508-200109000-00003.
PubMed 11587109Rafer 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.
PubMed 25607117Dileo, C., Bradt, J. (2005). Medical music therapy: a meta-analysis & agenda for future research. Cherry Hill, NJ: Jeffrey Books.
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.
PubMed 24163271What is music therapy? Retrieved from http://www.musictherapy.org/about/musictherapy/
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.
PubMed 26753216Robb, 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.
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.
PubMed 18036465Modesti 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.
PubMed 20160655Madson 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.
PubMed 21275333Kleiber 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.
PubMed 22985428Chi 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.
PubMed 21508712
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT02692768
- Acronym / sponsor ID
- STUDY00004093
- Conditions
- Arthritis
- Keywords
- total shoulder arthroplasty, total shoulder replacement, adult, reverse shoulder arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- April ArmstrongUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live Music Therapy | Active comparator | Other: Live Music TherapyLive 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. |
| Recorded Music Therapy | Active comparator | Other: Recorded Music TherapyRecorded 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. |
| Control | Active comparator | Other: ControlThis group will receive standard of care with no music therapy intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Music TherapyPatients 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 | Live Music Therapy |
| Recorded Music TherapyPatients 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 | Recorded Music Therapy |
| ControlPatients 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. | Other | Control |
Primary outcome
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.
1 secondary outcome
Change from baseline in anxiety scores on the PROMIS Emotional Distress-Anxiety-Short Form at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 24981553Levy 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.
- BackgroundThe Joint Commission. (2015). Facts about pain management. Retrieved from http://www.jointcommicssion.org/pain_management on 09.08.2015.
- BackgroundThe Joint Commission. (2014). Clarification of the pain management standard. Joint Commission Perspectives, 34, 11, 11.
- Background: PubMed 11587109Epker J, Block AR. Presurgical psychological screening in back pain patients: a review. Clin J Pain. 2001 Sep;17(3):200-5. doi: 10.1097/00002508-200109000-00003.
- Background: PubMed 25607117Rafer 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.
- BackgroundDileo, C., Bradt, J. (2005). Medical music therapy: a meta-analysis & agenda for future research. Cherry Hill, NJ: Jeffrey Books.
- Background: PubMed 24163271Cepeda 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.
- BackgroundWhat is music therapy? Retrieved from http://www.musictherapy.org/about/musictherapy/
- Background: PubMed 26753216Tan 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.
- BackgroundRobb, 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: PubMed 18036465Stouffer 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.
- Background: PubMed 20160655Modesti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
April D Armstrong, M.D. principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Music Therapy and Recorded Music Therapy in people with Arthritis, run by April Armstrong at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain scores on the visual analog scale at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692768, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.