Music Interventions for Patients Undergoing Hemodialysis

NCT04959682 | Completed DMC

• 1 other identifier: Music & Hemodialysis
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is found to be one of the most persistent problems among patients in treatment with hemodialysis, and associated with impaired health-related quality of life. A few, non-randomized controlled trials have found positive effects on fatigue by offering pre-recorded music intra-dialytic, however, without conclusive results. So far, no studies have investigated the feasibility of integrating person-tailored live music interventions performed by professional musicians into a hemodialysis setting. This leaves a deficit in knowledge for intervention planning, understanding and effectiveness of live music on fatigue, wellbeing and feelings of meaningfulness in this group of patients. Methods: A pilot randomized controlled trial combined with qualitative methods. The data collection will involve recruitment of 24 patients from an outpatient clinic over a six-week period. The patients will be randomized into either an intervention group or a control group. Patients in the intervention group will be offered a 30-minute session of patient-tailored live music intervention per week for six consecutive weeks. Patients in the control group will receive standard care. Quantitative analysis on immediate post-dialysis fatigue (VAS), and long-term fatigue (MFI-20), anxiety, depression (HADS) and treatment satisfaction (VAS) will show the potential effectiveness of intervention. Qualitative analysis of informal-interviews (patients/staff), observational data (patients) and focus group interviews (staff/musicians) will explore an in-depth understanding of whether music will improve wellbeing and create feelings of meaningfulness among this group of patients as well as to assess feasibility acceptability among patients, musicians and staff. Perspectives: This trial will ensure a firm methodological approach for the development of a future definitive randomized controlled trial of music intervention for fatigue reduction and wellbeing among hemodialysis patients.

Conditions

Renal Failure

Keywords

Music intervention; Feasibility; Kidney failure; Mixed method; Renal dialysis; Randomized Controlled Pilot Study

Outcome Measures

Primary Outcomes (3)

• Immediate fatigue

  Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue

  Change from baseline immediate fatigue at 8 weeks. VAS is measured at baseline (visit 1), after visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and at follow-up (visit 8).

• Longterm fatigue

  Multidimensional Fatigue Inventory (MFI-20). Higher MFI-20 score means higher levels of fatigue

  Change from baseline longterm fatigue at 8 weeks. MFI-20 is measured at baseline (visit 1) and at follow-up (visit 8)

• Post-dialysis fatigue-diary

  Visual Analogue Scale (VAS). Higher VAS score means higher levels of fatigue

  Change from baseline post dialysis fatigue at 8 weeks. Post-dialysis fatigue is measured the day after visit 2, visit, 3, visit 4, visit 5, visit, 6

Secondary Outcomes (4)

• Relaxation

  Change from baseline relaxation at 8 weeks. VAS is measured at baseline (visit 1), after visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and at followup (visit 8)

• Anxiety and Depression

  Change from baseline anxiety and depression at 8 weeks. HADS is measured at baseline (visit 1) and follow-up (visit 8)

• Treatment satisfaction

  Change from baseline treatment satisfaction at 8 weeks. VAS is measured at baseline (visit 1) and at follow-up (visit 8)

• Work engagement (staff)

  Change from baseline work engagement at 8 weeks. UWES is measured at baseline (visit 1) and at follow-up (visit 8)

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group will receive 30 minutes of patient-tailored instrumental music in the beginning of one weekly hemodialysis treatment for a period of six weeks

Other: Music Intervention

Control group

NO INTERVENTION

The procedure in the control group is the same as in the intervention group, except that they don't listen to music

Interventions

Music Intervention OTHER

After rating levels of fatigue and relaxation, the professional health care musicians will play 30 minutes of patient-tailored, pleasant instrumental music with a combination of relaxing (on average 60-80 bpm) and lively, slightly more up-beat tempo to regulate arousal-levels

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Scheduled to receive hemodialysis treatment
• Able to understand written and spoken Danish

You may not qualify if:

• Deafness
• Severe mental illness

Sponsors & Collaborators

• University of Southern Denmark: lead
• The Royal Academy of Music Aarhus/Aalborg: collaborator
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator
• Hanze University of Applied Sciences Groningen: collaborator
• University of Music and Performing Arts, Vienna: collaborator
• University Hospital of Southern Denmark: collaborator

Study Sites (1)

Margrethe Langer Bro

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pia Dreyer, PhD

  Institute of Public Health, University of Aarhus

  STUDY CHAIR

• Bibi Gram, PhD

  Regional Health Research, University of Southern Denmark

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: July 13, 2021
• Study Start: April 21, 2021
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)