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Music TherapyNCT03829813

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

A study testing Music therapy in people with Music Therapy and Pain, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Music Therapy, Pain, Patient Satisfaction
What is being tested?
Music therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteCanada
Study dates
1 Jan 2019to 16 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Non-English speaking participants

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Foothill Medical Centre

    Calgary, Alberta, T2N 2T9

Other trials in Canada

About this study

Official title: Does Music Therapy Improve Patient Mood, Pain, Satisfaction and Caregiver Satisfaction on Adult Inpatient Acute Neurological Units?

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

Read the detailed description

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:
  2. Semi-structured patient +/- family satisfaction questionnaire and interview post music therapy session
  3. Semi-structured inpatient unit staff questionnaire and interview (exploring themes of: self-perceived stress, workload, barriers, relationships, mood, pain)
  4. Focus groups of patients, families, staff addressing above areas
  5. Quantitative measures:
  6. Visual analog scale, mood pre- and post- music therapy session
  7. 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.

Being tested
Music therapy
Medical subject headings
Pain, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music therapyOther

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

Study groups in NCT03829813
Study groupRoleWhat they receive
PatientsExperimentalMusic 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.
Receives: Other: Music therapy
FamilyExperimentalFamily 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.
Receives: Other: Music therapy
Administration and StaffExperimentalStaff/Administration are not participants in music therapy, but rather have observed sessions, or worked as co-treating clinicians with music therapists for patient participants.
Receives: Other: Music therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 1 month following music therapy intervention

Secondary outcomes (3)
  1. Pain Visual Analogue Scale

    Measurement instrument that measures participants subjective perception of pain believed to range across a continuum of values.

    Scale: 0 (minimum, no pain) - 10 (maximum, very severe pain).

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

  2. Mood Visual Analogue Scale

    0 (minimum, not at all happy) - 10 (maximum, very happy).

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

  3. Patient Satisfaction

    Likert Scale:

    1. - Very dissatisfied
    2. - Somewhat dissatisfied
    3. - Neutral
    4. - Somewhat satisfied
    5. - Very satisfied

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2019
  2. Study start1 Jan 2019
  3. Primary completion16 Mar 2020
  4. Study completion16 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Mixed methods study with pre and post intervention surveys and Visual analog scales, combined with focus groups/interviews of patients, family members and staff
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03829813
Sponsor's protocol ID
REB18-1145
Status last verified
Oct 2018
First submitted
26 Oct 2018
Last updated
25 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Music therapy in people with Music Therapy and Pain, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative data from focus groups (time frame: Up to 1 month following music therapy intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.

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