Effects of Music Listening on Mood in an Inpatient Rehabilitation

February 23, 2021 updated by: King's College Hospital NHS Trust

A Single Case Experimental Design Study Exploring the Effect of Music in an Inpatient Neuropsychological Rehabilitation Setting

The aim is to examine whether self-selected music can improve mood (as well as cognitive function) in stroke patients at an inpatient rehabilitation unit. Additionally, the feasibility of such an intervention will be assessed.

Hypotheses:

  • The current intervention will be found to have a high feasibility.
  • Stroke patients will exhibit improved mood during the music listening intervention phase compared to their baseline phase.
  • Patients will show improvements in engagement in therapy if non-compliance was a previous issue (as demonstrated by therapist feedback regarding attendance of therapy sessions).
  • Patients will experience improved cognitive (memory) function (i.e. immediate and delayed free recall) during the intervention phase compared to baseline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is one of the leading causes of disability in the world. Research has shown that in the aftermath of a stroke, patients continue to experience various impairments even years after the stroke. For example, research has shown that stroke survivors continue to experience both cognitive impairments (e.g. executive dysfunction) and low mood (e.g. depression) even after more than 5 years since the stroke has passed. A further study was able to link low mood with reduced engagement in therapy, which has been found to lead patients to experience less benefits from the given therapy.

Due to the lack of supporting evidence for pharmacological and psychological treatments, music intervention was introduced with positive results being reported in regards to patients' mood and cognitive abilities. For example, one study found that stroke patients who listened to self-selected music were likely to experience a significant improvement in their mood and cognitive abilities when compared to another group who listened to audiobooks.

The current study aims to build on previous research by utilising a novel study design that has not been previously used to assess the feasibility and effectiveness of music intervention on the mood of patients located at an inpatient rehabilitation unit. The chosen design, single-case experimental design, allows researchers to take into account the individual differences of the patients, which cannot be considered when using an experimental design which needs a group of similar characteristics. In addition, by using a non-concurrent multiple baseline design, the researchers will be able to show that any changes occurring to the target behaviour (mood) will be due to the intervention itself rather than any other extraneous variables found in the environment, as three different time lengths will be used for the baseline phase (5, 10, and 15 days). The aim of the study is to provide data that support the feasibility and effectiveness of music intervention as an inexpensive and simple method for improving mood in stroke patients at an inpatient rehabilitation unit. It also aims to show similar effectiveness in increasing cognitive impairment and therapy engagement.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Good grasp of the English Language
  • Patients at the Frank Cooksey Rehabilitation Unit or transferring to the unit from an acute stroke ward
  • Recent diagnosis of stroke using MRI or CT scans
  • Low mood; will be confirmed by the clinical psychologist on the ward using mood screens as appropriate

Exclusion Criteria:- Severe or global aphasia, which interferes with their ability to understand instructions

  • Have a diagnosis of dementia
  • Patients who lack the capacity to consent

The study will also aim to exclude patients who have severe cognitive impairment, as assessed by the occupational therapists and clinical psychologist on the ward using screens or functional assessment as appropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Baseline
Participants will not listen to music for 5 to 15 days based on the baseline duration they were assigned.
Experimental: Intervention
Participants will listen to music for 3 weeks.
Behavioral: Self-selected music
Participants will be given iPods and headphones to listen to their music

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the CORE-10 mood screen
Time Frame: up to 6 weeks
questionnaire measure of distress, functioning and risk
up to 6 weeks
Change in self-report diary
Time Frame: up to 6 weeks
will assess feasibility by examining how frequently the patients are listening to music
up to 6 weeks
Change in self-report by therapists
Time Frame: up to 6 weeks
Will help to assess patients' engagement in therapy before during and after intervention
up to 6 weeks
Change in the Montreal Cognitive Assessment
Time Frame: up to 6 weeks
Will help to explore changes in cognition before and after the intervention. Minimum value=0, maximum value=30, better scores mean better outcome.
up to 6 weeks
Change in The Brain Injury Rehabilitation Trust Memory and Information Processing Battery (examines memory and information processing. Only the story recall subcategory will be used)
Time Frame: up to 6 weeks
Will help to explore changes in cognition (memory) before and after the intervention Minimum value=0, maximum value=60. Better scores mean better outcome
up to 6 weeks
Change in the Mood Likert Scale
Time Frame: up to 6 weeks
Ad hoc scale made for the study for participants to rate their mood. It is a Likert scale (0 is very relaxed, 10 is very stressed). Higher score thus mean worse outcome.
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College Hospital NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giulia Bellesi, DClinPsy, King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 261210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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