Effects of Music Therapy on Mood, Pain, Patient and Staff Satisfaction on Adult Inpatient Neurological Units

NCT ID: NCT03829813

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objective: Does music therapy improve mood, pain and patient satisfaction on adult inpatient neurological units? Is music therapy an acceptable and feasible intervention in an adult inpatient neurological unit based on patient, family, and care provider satisfaction measures?

Population: Foothills Medical Centre (FMC) acute neurological and neurorehabilitation units (i.e., 111, 112, 101, 58 Neurorehab), ages \>18

Background: Music therapy is the therapeutic application of music to rehabilitate cognitive, motor, and sensory dysfunction due to disease. Its treatment techniques are based upon scientific knowledge of music perception, production and its effects on nonmusical brain and behavior functions like gait, balance, speech, mood and motivation. Music is also known to have a wide range of physiological effects on the human body including changes in heart rate, respiration, blood pressure, skin temperature, and muscle tension. Music provokes emotions mediated via neuro-hormones such as serotonin and dopamine, and is experienced as joyous or rewarding through activity changes in the amygdala, ventral striatum and other parts of the limbic system.

Music therapy has been applied across a broad range of clinical conditions from inpatients to outpatients, cardiac, diabetes and cancer care to surgical and ICU settings, and in pediatric through adult and geriatric populations. The majority of clinical studies focus on neurological patients with sensorimotor, speech and gait impairments, however, music has been shown to improve mental state and functioning in a wide variety of psychiatric disorders including depression, anxiety, and dementia, as well as reducing anxiety in patients with asthma, osteoarthritis, those undergoing dental procedures or perioperative anesthesia. There is some research to support its mood benefits in stroke and brain injury patients.

Music therapy has been found to be an effective complementary treatment for cancer-related pain, lithotripsy, labor, and fibromyalgia. Recent reviews have demonstrated reductions in postoperative pain and anxiety, decreased consumption of sedatives and analgesics and increased patient satisfaction. The reductions in anxiety were equal or greater than midazolam/benzodiazepines. This may be particularly beneficial in neurological patients who may be more susceptible to adverse effects from psychoactive, sedating and analgesic medications. Music can provide a filter for unpleasant, unfamiliar sounds common to the hospital environment and improve sleep quality. These positive effects may greatly assist the common issues of fatigue in cognitively impaired, confused or agitated neurological inpatients. Furthermore, Chlan has recently demonstrated cost-effectiveness of music therapy interventions in reducing anxiety in the ICU.

Music therapy may also have beneficial effects for staff and families. Some studies have demonstrated cost-effectiveness with less staff time required for procedures, administering sedatives and pain medications, and fewer days on mechanical ventilation in the ICU. Perez-Cruz studied patients, relatives, and healthcare workers' preference for background music in patient areas with an average 71% in all three groups. Lower perceived stress level, cortisol, heart rate and mean arterial pressures were also observed in voluntary first-line nurses and students while listening to music.

This study will expand the research base in the inpatient neurological population and explore staff perceptions and satisfaction with music therapy. The aim of this mixed methods study is to explore immediate pre and post music therapy intervention effects on mood, pain, and satisfaction in the inpatient neurological population and to explore perceived caregiver and staff satisfaction with music therapy on inpatient neurological units.

Intervention: 20-40 min treatment sessions 1:1 within acute neurological patient rooms, or private room by qualified music therapist once weekly and/or group music therapy sessions maximum 6-8 patients \< or = 1 hour. This includes a variety of music therapy techniques used to target mood, pain, socialization, expressive speech, attention/cognitive or sensorimotor functional goals.

Methods: Mixed methods study design.

1. Qualitative measures:

1. Semi-structured patient +/- family satisfaction questionnaire and interview post music therapy session
2. Semi-structured inpatient unit staff questionnaire and interview (exploring themes of: self-perceived stress, workload, barriers, relationships, mood, pain)
3. Focus groups of patients, families, staff addressing above areas
2. Quantitative measures:

1. Visual analog scale, mood pre- and post- music therapy session
2. Visual analog scale, pain pre- and post- music therapy session

Recruitment: Patients (and their families when available) referred to Music therapy on Acute Neuro, Neurorehab units would be invited to participate in research study with informed consent obtained prior to interviews, focus groups and data collection. Unit Staff would also be invited to participate in interviews and focus groups with informed consent prior to data collection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Music Therapy Pain Patient Satisfaction Inpatients Affect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Mixed methods study with pre and post intervention surveys and Visual analog scales, combined with focus groups/interviews of patients, family members and staff
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

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.

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

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

Family

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.

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

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

Administration and Staff

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.

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music therapy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Non-English speaking participants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Music Centre Studio Bell

UNKNOWN

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephanie Plamondon

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Foothill Medical Centre

Calgary, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REB18-1145

Identifier Type: -

Identifier Source: org_study_id