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Completed

NCT Number: NCT04975607

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

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.

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Key information

Conditions

Lung Transplant; Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2021
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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