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.
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.
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.
- Qualitative measures:
- Semi-structured patient +/- family satisfaction questionnaire and interview post music therapy session
- Semi-structured inpatient unit staff questionnaire and interview (exploring themes of: self-perceived stress, workload, barriers, relationships, mood, pain)
- Focus groups of patients, families, staff addressing above areas
- Quantitative measures:
- Visual analog scale, mood pre- and post- music therapy session
- 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
- Music Therapy, Pain, Patient Satisfaction, Inpatients, Affect
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
Patient Satisfaction
Likert Scale:
- - Very dissatisfied
- - Somewhat dissatisfied
- - Neutral
- - Somewhat satisfied
- - 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.
- First posted4 Feb 2019
- Study start1 Jan 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- National Music Centre Studio Bell
- Responsible party
- Sponsor
- Investigators
- Stephanie Plamondon, Principal investigator, University of Calgary
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Music Therapy Improve Patient Mood, Pain, Satisfaction and Caregiver Satisfaction on Adult Inpatient Acute Neurological Units?
- ClinicalTrials.gov ID
- NCT03829813
- Acronym / sponsor ID
- REB18-1145
- Conditions
- Music Therapy, Pain, Patient Satisfaction, Inpatients, Affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- National Music Centre Studio Bell
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study examining the benefits of music therapy on patients, families, and unit staff on acute neurologic or inpatient rehabilitation units.
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.
- Qualitative measures:
- Semi-structured patient +/- family satisfaction questionnaire and interview post music therapy session
- Semi-structured inpatient unit staff questionnaire and interview (exploring themes of: self-perceived stress, workload, barriers, relationships, mood, pain)
- Focus groups of patients, families, staff addressing above areas
- Quantitative measures:
- Visual analog scale, mood pre- and post- music therapy session
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Music therapyMusic 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. |
| Family | Experimental | Other: Music therapyFamily 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. |
| Administration and Staff | Experimental | Other: Music therapyStaff/Administration are not participants in music therapy, but rather have observed sessions, or worked as co-treating clinicians with music therapists for patient participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Non-English speaking participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy20 to 40 minute music therapy treatment session with a qualified music therapist. | Other | Administration and Staff, Family, Patients |
Primary outcome
Qualitative data from focus groups
Time frame: Up to 1 month following music therapy intervention
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.
3 secondary outcomes
Pain Visual Analogue Scale
Time frame: T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment
Mood Visual Analogue Scale
Time frame: T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment
Patient Satisfaction
Time frame: T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Music Therapy
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Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit
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The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns
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Musical Group Intervention for Children in Shelters
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Relational Music Therapy Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Plamondon principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
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.