Clinical trial NCT04975607: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant; Complications
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Anxiety levels
timeFrame: Changes from baseline to post-surgery day 6
measure: Change in Pain levels (CPOT)
timeFrame: Changes from baseline to post-surgery day 6
measure: Change in Pain levels (Pain number scale)
timeFrame: Changes from baseline to post-surgery day 6
measure: Change in dosage of benzodiazepine medication
timeFrame: Changes from baseline to post-surgery day 6
measure: Change in dosage of pain medication
timeFrame: Changes from baseline to post-surgery day 6
measure: Change in length of sleep
timeFrame: Changes from baseline to post-surgery day 6
measure: Change in length of stay in ICU and in hospital
timeFrame: Changes from baseline to post-surgery day 6
measure: Change in total time of intubation
timeFrame: Intubation prior to surgery until extubation (Post-surgery day 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Emily Pickett
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Methodist University
name: Daniel Tague, PhD
role: PRINCIPAL_INVESTIGATOR
References: