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

NCT04975607 | Completed

• 1 other identifier: STU-2019-1409
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant; Complications

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• Change in dosage of benzodiazepine medication

  Comparing medication dosage between intervention group vs control group.

  Changes from baseline to post-surgery day 6

• Change in dosage of pain medication

  Comparing medication dosage between intervention group vs control group

  Changes from baseline to post-surgery day 6

• 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

• 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

• 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)

Study Arms (2)

Music Therapy Group

EXPERIMENTAL

Behavioral: Music Therapy

Control Group

NO INTERVENTION

Interventions

Music Therapy BEHAVIORAL

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.

Music Therapy Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Post-lung transplant patients with chests left open directly after OR (before being taken back to the OR and having their chests closed)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75032, United States

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emily Pickett

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Daniel Tague, PhD

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Unit Based Educator for Clinical Care

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 23, 2021
• Study Start: October 1, 2021
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: March 10, 2025

Record last verified: 2025-02

Locations

US (1)