Music Interventions for Patients Undergoing Hemodialysis

NCT ID: NCT04959682

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2021-08-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Music Intervention

Intervention Type: 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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Intervention

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Deafness
• Severe mental illness

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Royal Academy of Music Aarhus/Aalborg

UNKNOWN

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Hanze University of Applied Sciences Groningen

OTHER

Sponsor Role: collaborator

University of Music and Performing Arts, Vienna

UNKNOWN

Sponsor Role: collaborator

University Hospital of Southern Denmark

UNKNOWN

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pia Dreyer, PhD

Role: STUDY_CHAIR

Institute of Public Health, University of Aarhus

Bibi Gram, PhD

Role: STUDY_CHAIR

Regional Health Research, University of Southern Denmark

Locations

Margrethe Langer Bro

Odense, , Denmark

Countries

Denmark

Other Identifiers

Music & Hemodialysis

Identifier Type: -

Identifier Source: org_study_id