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

Lung Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04975607
• Other study ID #: STU-2019-1409
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in dosage of benzodiazepine medication	Comparing medication dosage between intervention group vs control group.	Changes from baseline to post-surgery day 6
Primary	Change in dosage of pain medication	Comparing medication dosage between intervention group vs control group	Changes from baseline to post-surgery day 6
Primary	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
Primary	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
Primary	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)