Lung Transplant; ComplicationsNCT04975607
Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: a Pilot Study
A study testing Music Therapy in people with Lung Transplant; Complications, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 11 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All post-lung transplant patients at UTSW Clements University Hospital starting June 1, 2021
Who cannot join
- Post-lung transplant patients with chests left open directly after OR (before being taken back to the OR and having their chests closed)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75032
About this 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.
- Conditions
- Lung Transplant; Complications
- Being tested
- Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy Group | Experimental | Not described Receives: Behavioral: Music Therapy |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: Changes from baseline to post-surgery day 6
Change in dosage of benzodiazepine medication
Comparing medication dosage between intervention group vs control group.
Measured: Changes from baseline to post-surgery day 6
Change in dosage of pain medication
Comparing medication dosage between intervention group vs control group
Measured: 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
Measured: 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
Measured: Changes from baseline to post-surgery day 6
Change in total time of intubation
Comparing duration of intubation between intervention group vs control group
Measured: Intubation prior to surgery until extubation (Post-surgery day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Oct 2021
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Pickett, University of Texas Southwestern Medical Center
- Investigators
- Emily Pickett, Principal investigator, University of Texas Southwestern Medical CenterDaniel Tague, PhD, Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975607
- Sponsor's protocol ID
- STU-2019-1409
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT04975607
- Acronym / sponsor ID
- STU-2019-1409
- Conditions
- Lung Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Group | Experimental | Behavioral: Music Therapy |
| Control Group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All post-lung transplant patients at UTSW Clements University Hospital starting June 1, 2021
Key exclusion criteria (1 listed)
- Post-lung transplant patients with chests left open directly after OR (before being taken back to the OR and having their chests closed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyThe 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. | Behavioural | Music Therapy Group |
Primary outcome
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.
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).
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).
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.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Related trials for Lung Transplant; Complications
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Pickett principal investigator
University of Texas Southwestern Medical Center
Daniel Tague, PhD principal investigator
Southern Methodist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Lung Transplant; Complications, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety levels (time frame: Changes from baseline to post-surgery day 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.