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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04975607
Enrollment
89
Registered
2021-07-23
Start date
2021-10-01
Completion date
2023-04-11
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplant; Complications

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.

Interventions

BEHAVIORALMusic 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.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Anxiety levelsChanges from baseline to post-surgery day 6Comparing 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 6Comparing 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)Changes from baseline to post-surgery day 6Comparing 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 medicationChanges from baseline to post-surgery day 6Comparing medication dosage between intervention group vs control group.
Change in dosage of pain medicationChanges from baseline to post-surgery day 6Comparing medication dosage between intervention group vs control group
Change in length of sleepChanges from baseline to post-surgery day 6Comparing Fitbit data on length of sleep between intervention group vs control group
Change in length of stay in ICU and in hospitalChanges from baseline to post-surgery day 6Comparing length of stay between intervention group vs control group
Change in total time of intubationIntubation prior to surgery until extubation (Post-surgery day 4)Comparing duration of intubation between intervention group vs control group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026