Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03925168 |
| Other study ID # |
2017-866 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 8, 2019 |
| Est. completion date |
January 1, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Tulane University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to determine the effect of music therapy during dialysis on:
depression, anxiety, quality of life, blood pressure, heart rate, medication compliance,
compliance with dialysis treatment, number of hospitalizations, pain level, and energy level.
Description:
This study will be a cluster-randomized clinical trial. In order to limit contamination bias,
dialysis sessions at each site will be randomized to the experimental group or the wait-list
control group. For example, patients receiving MWF first-session dialysis may be randomized
to the experimental group while patients receiving TTS second-session dialysis may be
randomized to the control group. Due to this randomization scheme, patients will be able to
receive individualized music therapy while sitting in an open dialysis unit. The subject
population includes English-speaking, adult (21+) hemodialysis patients who receive dialysis
at the one of the two outpatient dialysis centers included in this study. Subjects will be
excluded if they do not speak English or if they are deaf as these patient populations would
not be likely to benefit from music therapy administered in English. Up to 100 patients will
be enrolled in this study.
Patients receiving dialysis at DCI, Inc, who consent to participate and are randomized to the
experimental group will receive 30-minute music therapy sessions over the course of several
months. Music therapy will be administered by certified music therapists and music therapy
students according to the Eyre (2008) decision tree model. According to this model, the
patient chooses his or her preferred musical intervention at the beginning of each session.
Choices include: sing songs, compose a song, listen to songs, play instruments, have an
imagery experience, listen to music, improvise, and use music for relaxation. If the patient
is unwilling or unable to make a decision, then the music therapist will choose an
intervention based on the patient's perceived needs. For example, if the perceived need is
expression of emotions, then the music therapist may suggest song composition, song choice,
song singing, or improvisation. The music therapist will continue to assess the client's
perceived needs based on their physical, verbal, and emotional responses to the chosen
musical interventions, and the therapist will adjust their musical interventions accordingly
(the complete Eyre Decision Tree Model is attached). The instruments utilized in music
therapy will include a classic guitar, gato box (a small, drum-like instrument), and a
3-piece egg shaker set. All of these instruments can be played loudly enough to provide music
therapy to the patient but softly enough as to not disturb the adjacent patients in the
dialysis unit. In fact, these instruments are frequently used to provide music therapy to
patients in open neonatal intensive care units.
The primary variables in this study include depression, anxiety, and quality of life. The
median time to recovery for a major depressive episode is 20 weeks; therefore, patients
randomized to the control group will receive music therapy for approximately 20 weeks.
Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9), anxiety will be
measured using the Generalized Anxiety Disorder-7 (GAD-7), and quality of life will be
measured using the Kidney Disease and Quality of Life (KDQOL™-36) questionnaire. These tools
are self-administered questionnaires that will be provided by the music therapists to both
the experimental and control groups once a month during the study. Any patient with a PHQ-9
score greater than 10 (moderate depression) or a GAD-7 score greater than 10 (moderate
anxiety) will additionally be given resources for available mental health providers in the
area. While these tools are validated to be utilized every two weeks, they will be utilized
every month during this study to limit testing fatigue. In addition, the PHQ-9, GAD-7, and
KDQOL™-36 will be administered 30, 60, and 90 days after the experimental group receives
their last music therapy session to both the experimental and control groups to assess for
recurrent episodes. Among patients with major depressive disorder, recurrent episodes occur
in approximately 50 percent. The risk of reoccurrence appears to be greatest in the first few
months after cessation of depressive therapy.
The secondary variables in this study include blood pressure, heart rate, medication
compliance, compliance with dialysis treatment, number of hospitalizations, pain level, and
energy level. The music therapists will record the heart rate (HR) and blood pressure (BP) of
each patient at the beginning of dialysis as well as at the beginning and end of music
therapy (or a 30-minute period during which music therapy would have been administered).
These HRs and BPs will be recorded using nursing vitals. Prior to the start of each session,
the music therapist will provide self-administered questionnaires that ask patients to rate
their pain (utilizing the Numeric Rating Scale [NRS-11]), mood, anxiety, and energy level.
The patients will rate their pain, mood, anxiety, and energy level at the end of the session
as well. The music therapist will record if the patient stayed for their entire treatment, or
if they asked to stop dialysis early (the complete weekly and monthly data collection forms
are attached). Music therapy sessions will be audio recorded using a condenser microphone and
iPad Pro, and any subjective feedback from dialysis patients about music therapy sessions
will be recorded as well.
