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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04975607
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Emily Pickett, University of Texas Southwestern Medical Center

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Lung Transplant; Complications Behavioral: Music Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: A Pilot Study
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Music Therapy Group 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.
No Intervention: Control Group


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975607


Contacts
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Contact: Emily Pickett 214-633-0900 Emily.Pickett@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75032
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Emily Pickett University of Texas Southwestern Medical Center
Principal Investigator: Daniel Tague, PhD Southern Methodist University
More Information
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Responsible Party: Emily Pickett, Unit Based Educator for Clinical Care, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04975607    
Other Study ID Numbers: STU-2019-1409
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No