Music interventions in hyperacute and acute stroke patients
| ISRCTN | ISRCTN13104282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13104282 |
- Submission date
- 04/11/2024
- Registration date
- 12/11/2024
- Last edited
- 12/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Music and sounds have been shown to have beneficial effects on pain, anxiety and blood pressure in various settings. However, music and sound have not been studied specifically in patients with acute stroke. It is possible music or pleasant sounds may help control pain, anxiety or blood pressure abnormalities which may occur immediately following a stroke. This may supplement or negate the need for pharmacological medications which are commonly used but have known side effects.
Who can participate?
Patients aged 18 to 100 years old who are hospitalized within 24 hours from the onset of a suspected stroke
What does the study involve?
This study involves participants being randomly allocated, like a coin Filip, to listen to music or pleasant sounds for up to 12 hours following the onset of a stroke or to standard stroke care alone (without listening to music).
What are the possible benefits and risks?
There may be less pain or anxiety in those listening to music as compared to no music. Additionally, there may be less variability in blood pressure which is possibly harmful to stroke patients. Risks may include a patient not liking the use of music resulting in agitation or confusion.
Where is the study run from?
The University of Michigan Health-West, USA
When is the study starting and how long is it expected to run for?
January 2019 to September 2024
Who is funding the study?
The University of Michigan Health-West, USA
Who is the main contact?
Dr Jeffrey Fletcher, Jeffrey.fletcher@umhwest.org, jflet10121@aol.com
Contact information
Public, Scientific, Principal Investigator
9636 Waterstone Dr SE
Byron Center, Michigan
49315
United States of America
| Phone | +1 7348458698 |
|---|---|
| Jeffrey.fletcher@umhwest.org |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Do music interventions, as compared to no music, reduce systolic blood pressure variability, pain and anxiety in hyperacute stroke |
| Study acronym | MIHAS |
| Study objectives | Patients or their legally authorized representatives will be highly supportive of music interventions in hyperacute stroke. Music interventions will reduce pain, anxiety and systolic blood pressure variability in hyperacute stroke patients. |
| Ethics approval(s) |
Approved 30/01/2020, University of Michigan Health-West Institutional Review Board (University of Michigan Health-West Professional Building, 2122 Health Dr. SW, Suite 233, Wyoming, MI 49519, United States of America; +1 616 252 5026; irb@umhwest.org), ref: 2020-010 |
| Health condition(s) or problem(s) studied | Treatment of pain, anxiety and systolic blood pressure variability in patients hospitalized with acute stroke |
| Intervention | Eligible patients (or their legally authorized representative) were approached in the emergency department or obtained on admission to the inpatient ward and electronic consent. Staff not involved in the study implementation used a computer random number generator to generate a randomization sequence and allocation concealment was obtained by sealed opaque envelopes. Excluding the randomization process and use of the music or sound intervention (in the intervention group), all medical care of participants followed usual, disease-specific, care plans. Participants randomized to the intervention arm had 19 relaxation or pleasant sound stations to ambiently listen to on their in-room televisions. They also had options to listen to various music genres. Participants were asked to listen ambiently to music or sounds for the first hour of the trial and encouraged to listen to it frequently for the duration of the trial period however, there was not a specific time requirement. The trial period was a minimum of 6 hours with trial termination when the patient was discharged from the stroke unit, or neurological ICU, or after a maximum of 12 hours of data collection. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. The percentage of eligible patients approached for consent who were recruited into the trial measured using data collected in study records at one timepoint 2. The percentage of enrolled patients who completed the 6-hour trial data collection measured using data collected in study records at one timepoint |
| Secondary outcome measures | 1. The systolic blood pressure variability (SBPV) in the first 6 hours of the trial period, defined by the standard deviation of the SBP in the treatment arms, measured using cuff blood pressure measurements hourly 2. Secondary exploratory outcomes included the effect of treatment arm assignment (intention to treat) on the visual analog pain scale (0-10) and anxiety (visual analog scale 0-100) burden at 6 hours from enrollment |
| Overall study start date | 03/01/2019 |
| Completion date | 15/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 30 |
| Key inclusion criteria | Patients with acute stroke of any subtype admitted to the hospital within 24 hours of ictus |
| Key exclusion criteria | 1. Patients who refused consent 2. Patients at the end of life 3. Patients expected to have an operation or procedure |
| Date of first enrolment | 15/06/2024 |
| Date of final enrolment | 15/09/2024 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Wyoming
49519
United States of America
Sponsor information
Hospital/treatment centre
University of Michigan Health-West, 5900 Byron Center Ave
Wyoming
49519
United States of America
| Phone | +1-616-252-5020 |
|---|---|
| Research@umhwest.org | |
| Website | https://uofmhealthwest.org/ |
"ROR" |
https://ror.org/01zcpa714 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- MEDICINE AT MICHIGAN, Michigan Medicine, MM
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The dataset generated during the study will be available upon request from Dr Jeffrey Fletcher, Jeffrey.fletcher@umhwest.org, jflet10121@aol.com. Data will be stored for 7 years from publication date. The type of data that will be shared is anonymized individualized-level patient data. |
Editorial Notes
05/11/2024: Study's existence of the University of Michigan Health-West, Michigan Medicine, Institutional Review Board.
