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

• ClinicalTrials.gov Identifier: NCT04975607
• Recruitment Status: Recruiting
• First Posted: July 23, 2021
• Last Update Posted: November 3, 2022
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Emily Pickett, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: July 1, 2021
• First Posted Date: July 23, 2021
• Last Update Posted Date: November 3, 2022
• Actual Study Start Date: October 1, 2021
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2021)

• Change in Anxiety levels [ Time Frame: 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) [ Time Frame: 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 Pain levels (Pain number scale) [ Time Frame: 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 dosage of benzodiazepine medication [ Time Frame: Changes from baseline to post-surgery day 6 ]
  Comparing medication dosage between intervention group vs control group.
• Change in dosage of pain medication [ Time Frame: Changes from baseline to post-surgery day 6 ]
  Comparing medication dosage between intervention group vs control group
• Change in length of sleep [ Time Frame: 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 [ Time Frame: Changes from baseline to post-surgery day 6 ]
  Comparing length of stay between intervention group vs control group
• Change in total time of intubation [ Time Frame: Intubation prior to surgery until extubation (Post-surgery day 4) ]
  Comparing duration of intubation between intervention group vs control group

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Transplant; Complications

Intervention

Behavioral: Music Therapy

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.

Study Arms

• Experimental: Music Therapy Group
  Intervention: Behavioral: Music Therapy
• No Intervention: Control Group

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 14, 2021): 64
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Emily Pickett; 214-633-0900; Emily.Pickett@UTSouthwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04975607
• Other Study ID Numbers: STU-2019-1409
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Emily Pickett, University of Texas Southwestern Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Texas Southwestern Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Emily Pickett; University of Texas Southwestern Medical Center
• Principal Investigator: Daniel Tague, PhD; Southern Methodist University

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: November 2022