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

Not Applicable

Active, not recruiting

• Conditions: Lung Transplant; Complications
• Interventions: Behavioral: Music Therapy

• Registration Number: NCT04975607
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-23
• Study Start: 2021-10-01
• Primary Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• All post-lung transplant patients at UTSW Clements University Hospital starting June 1, 2021

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Therapy Group	Music Therapy	-

Primary Outcome Measures

Name	Time	Method
Change in total time of intubation	Intubation prior to surgery until extubation (Post-surgery day 4)	Comparing duration of intubation between intervention group vs control group
Change in Anxiety levels	Changes from baseline to post-surgery day 6	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.
Change in Pain levels (CPOT)	Changes from baseline to post-surgery day 6	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).
Change in dosage of benzodiazepine medication	Changes from baseline to post-surgery day 6	Comparing medication dosage between intervention group vs control group.
Change in dosage of pain medication	Changes from baseline to post-surgery day 6	Comparing medication dosage between intervention group vs control group
Change in Pain levels (Pain number scale)	Changes from baseline to post-surgery day 6	Comparing the scores from the Pain number scale before and after music therapy. Scores ranges between 0 (no pain) to 10 (maximum pain).
Change in length of sleep	Changes from baseline to post-surgery day 6	Comparing Fitbit data on length of sleep between intervention group vs control group
Change in length of stay in ICU and in hospital	Changes from baseline to post-surgery day 6	Comparing length of stay between intervention group vs control group

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States