Music Therapy and Dialysis: A Pilot Investigation Into the Effectiveness of Patient-Selected Music Interventions on Physiological, Psychological, and Quality-of-Life Outcomes
Music Therapy and Dialysis: A Pilot Investigation Into the Effectiveness of Patient-Selected Music Interventions on Physiological, Psychological, and Quality-of-Life Outcomes
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.
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.
Inclusion Criteria:

 -  English-speaking, adult (21+) hemodialysis patients who receive dialysis at the one of
 the two outpatient dialysis centers

 Exclusion Criteria:

 -  do not speak English, deafness