Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: A Pilot Study

Study Overview
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Brief Summary
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The purpose of this prospective pilot study is to determine if live music therapy reduces patients' perception of pain and anxiety, reduces benzodiazepine use and pain medication use, length of stay in the ICU, and length of stay in hospital, and improves sleep in post-lung transplant patients. The purpose and objectives of the study are the following: To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived anxiety in post-lung transplant patients. To determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived pain in post-lung transplant patients. To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's use of benzodiazepine medication for anxiety. To determine if music therapist delivered patient preferred live music and therapeutic intervention three times in post-lung transplant patients will reduce participant's use of pain medication. To determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's total time of intubation, length of stay in ICU, and length of stay in the hospital. To determine if music therapist delivered patient preferred live music and therapeutic intervention will improve the quality and length of sleep in post-lung transplant patients.

Official Title
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Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: A Pilot Study

Conditions
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Lung Transplant; Complications

Intervention / Treatment
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* Behavioral: Music Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All post-lung transplant patients at UTSW Clements University Hospital starting June 1, 2021 Exclusion Criteria: Post-lung transplant patients with chests left open directly after OR (before being taken back to the OR and having their chests closed)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy Group<br> | Behavioral: Music Therapy<br>* The three live music therapy sessions will be provided after lung transplant. All three music therapy sessions will employ a variety of data-based interventions to address pain, anxiety, and improve relaxation. Music therapy interventions may include patient preferred live music, active music listening, singing or other active music-making, and guided breathing and relaxation.<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety levels | Comparing the scores from the Hamilton Anxiety Rating Scale (HAM-A) scale before and after music therapy. Scores range between 0-56 where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | Changes from baseline to post-surgery day 6 | 
| Change in Pain levels (CPOT) | Comparing the scores from the Critical Care Pain Observation Tool (CPOT) scale before and after music therapy. Scores ranges between 0 (no pain) to 8 (maximum pain). | Changes from baseline to post-surgery day 6 | 
| Change in Pain levels (Pain number scale) | Comparing the scores from the Pain number scale before and after music therapy. Scores ranges between 0 (no pain) to 10 (maximum pain). | Changes from baseline to post-surgery day 6 | 
| Change in dosage of benzodiazepine medication | Comparing medication dosage between intervention group vs control group. | Changes from baseline to post-surgery day 6 | 
| Change in dosage of pain medication | Comparing medication dosage between intervention group vs control group | Changes from baseline to post-surgery day 6 | 
| Change in length of sleep | Comparing Fitbit data on length of sleep between intervention group vs control group | Changes from baseline to post-surgery day 6 | 
| Change in length of stay in ICU and in hospital | Comparing length of stay between intervention group vs control group | Changes from baseline to post-surgery day 6 | 
| Change in total time of intubation | Comparing duration of intubation between intervention group vs control group | Intubation prior to surgery until extubation (Post-surgery day 4) |