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

NCT03925168 | Completed DMC

• 1 other identifier: 2017-866
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (5)

• Depression

  Measured by Patient Health Questionnaire 9 (PHQ-9). The PHQ-9 measures depression symptoms. Scores range from 0 to 27. A score of 0 to 4 indicates no depression symptoms, 5 to 9 indicates mild symptoms, 10 to 14 indicates moderate symptoms, 15 to 19 indicates moderately severe symptoms, and 20 to 27 indicates severe symptoms.

  Until 90 days post study

• Anxiety

  Measured by Generalized Anxiety Disorder 7 patient screening tool (GAD-7). The GAD-7 measures anxiety symptoms. Scores range from 0 to 21. A score of 5 or higher indicates mild anxiety, 10 or higher indicates moderate anxiety, and 15 or higher indicates severe anxiety.

  Until 90 days post study

• Measuring change in Quality of life using Kidney Disease and Quality of Life 36 patient screening tool (KDQOL36)

  Measured by Kidney Disease and Quality of Life 36 patient screening tool. The KDQOL36 measures quality of life for kidney disease patients. Scores range from 36 to 172. Lower scores indicate greater quality of life. Appropriate scores vary by age.

  Until 90 days post study

• Compliance with dialysis

  Self-reported

  Up to 5 months

• Number of hospitalizations

  Self-reported

  Up to 5 months

Secondary Outcomes (6)

• Blood pressure

  Up to 5 months

• Heart rate

  Up to 5 months

• Medication compliance questionnaire.

  Up to 5 months

• Measure change in Pain using the Numeric Rating Scale 11 (NRS11)

  Up to 5 months

• Participant Energy

  Up to 5 months

Study Arms (2)

Experimental

EXPERIMENTAL

Music therapy

Behavioral: Music therapy

Control

NO INTERVENTION

No music therapy

Interventions

Music therapy BEHAVIORAL

Music therapy will be administered 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.

Experimental

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• do not speak English, deafness

Sponsors & Collaborators

• Tulane University: lead
• National Kidney Foundation, United States: collaborator

Study Sites (3)

DCI Canal Street

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

DCI West Bank

Terrytown, Louisiana, 70056, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Depression; Anxiety Disorders; Depressive Disorder, Major; Generalized Anxiety Disorder; Patient Compliance; Medication Adherence; Pain; Tachycardia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Depressive Disorder; Mood Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Neurologic Manifestations; Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Angelina Dixon, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized clinical trial

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 24, 2019
• Study Start: March 8, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)