Clinical trial NCT03925168: Music Therapy and Dialysis: A Pilot Investigation Into the Effectiveness of Patient-Selected Music Interventions on Physiological, Psychological, and Quality-of-Life Outcomes
Official title: Music Therapy and Dialysis: A Pilot Investigation Into the Effectiveness of Patient-Selected Music Interventions on Physiological, Psychological, and Quality-of-Life Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Depression
Anxiety
Major Depressive Disorder
Generalized Anxiety Disorder
Compliance, Patient
Compliance, Medication
Mood
Pain
Energy Supply; Deficiency
Quality of Life
Blood Pressure
Heart Rate Fast
Keywords: end stage kidney disease
depression
major depressive disorder
anxiety
generalized anxiety disorder
music therapy
dialysis
quality of life
blood pressure
heart rate
pain
energy
mood
medication compliance
music
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
First posted: 2019-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression
timeFrame: Until 90 days post study
measure: Anxiety
timeFrame: Until 90 days post study
measure: Measuring change in Quality of life using Kidney Disease and Quality of Life 36 patient screening tool (KDQOL36)
timeFrame: Until 90 days post study
measure: Compliance with dialysis
timeFrame: Up to 5 months
measure: Number of hospitalizations
timeFrame: Up to 5 months
Secondary outcomes:
measure: Blood pressure
timeFrame: Up to 5 months
measure: Heart rate
timeFrame: Up to 5 months
measure: Medication compliance questionnaire.
timeFrame: Up to 5 months
measure: Measure change in Pain using the Numeric Rating Scale 11 (NRS11)
timeFrame: Up to 5 months
measure: Participant Energy
timeFrame: Up to 5 months
measure: Mood
timeFrame: Up to 5 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: DCI Canal Street
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Terrytown
country: United States
facility: DCI West Bank
state: Louisiana
Study officials:
affiliation: Tulane University
name: Angelina Dixon, MD
role: PRINCIPAL_INVESTIGATOR
References: