NCT03829813

Brief Summary

A study examining the benefits of music therapy on patients, families, and unit staff on acute neurologic or inpatient rehabilitation units.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

November 25, 2020

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

October 26, 2018

Last Update Submit

November 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Qualitative data from focus groups

    Questions within the interview are designed to more deeply explore the areas of music therapy and how this program may influence stress, mood, pain, and the relationships between participants, caregivers, and hospital staff. Interviews will also touch upon barriers to music therapy involvement as experienced.

    Up to 1 month following music therapy intervention

Secondary Outcomes (3)

  • Pain Visual Analogue Scale

    T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment

  • Mood Visual Analogue Scale

    T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment

  • Patient Satisfaction

    T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment

Study Arms (3)

Patients

EXPERIMENTAL

Music therapy sessions. Planned 1:1 within acute neurology/rehabilitation patient rooms, or private rooms by a qualified music therapist once weekly and/or group music therapy sessions maximum 6-8 patients for less than or equal to one hour. Music therapy includes a variety of techniques used to target mood, pain, socialisation, expressive speech, attention/cognitive or sensorimotor functional goals.

Other: Music therapy

Family

EXPERIMENTAL

Family participation in music therapy treatment sessions. Planned 1:1 within acute neurology/rehabilitation patient rooms, or private rooms by a qualified music therapist once weekly and/or group music therapy sessions maximum 6-8 patients for less than or equal to one hour.

Other: Music therapy

Administration and Staff

EXPERIMENTAL

Staff/Administration are not participants in music therapy, but rather have observed sessions, or worked as co-treating clinicians with music therapists for patient participants.

Other: Music therapy

Interventions

20 to 40 minute music therapy treatment session with a qualified music therapist.

Administration and StaffFamilyPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute neurological inpatients and their families at Foothills Medical Centre that are receiving music therapy
  • Unit staff involved in care of patients receiving music therapy as inpatients
  • Age \> 18

You may not qualify if:

  • Non-English speaking participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothill Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

PainPatient Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Stephanie Plamondon

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Mixed methods study with pre and post intervention surveys and Visual analog scales, combined with focus groups/interviews of patients, family members and staff
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

February 4, 2019

Study Start

January 1, 2019

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

November 25, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations