Effects of Music Listening on Mood in an Inpatient Rehabilitation

NCT ID: NCT04431362

Last Updated: 2021-02-24

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants first complete a baseline phase before starting the intervention phase.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The measures will be completed by the clinical psychologist while the diary and checklist will be done by the patients with assistance from the research student or activity coordinators.

Study Groups

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Baseline

Participants will not listen to music for 5 to 15 days based on the baseline duration they were assigned.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants will listen to music for 3 weeks.

Group Type EXPERIMENTAL

Self-selected music

Intervention Type BEHAVIORAL

Participants will be given iPods and headphones to listen to their music

Interventions

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Self-selected music

Participants will be given iPods and headphones to listen to their music

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giulia Bellesi, DClinPsy

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Central Contacts

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Giulia Bellesi, DClinPsy

Role: CONTACT

01689866391

References

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Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004 Jul-Aug;13(4):171-7. doi: 10.1016/j.jstrokecerebrovasdis.2004.06.003.

Reference Type BACKGROUND
PMID: 17903971 (View on PubMed)

Dallery J, Cassidy RN, Raiff BR. Single-case experimental designs to evaluate novel technology-based health interventions. J Med Internet Res. 2013 Feb 8;15(2):e22. doi: 10.2196/jmir.2227.

Reference Type BACKGROUND
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Hammond MF, O'Keeffe ST, Barer DH. Development and validation of a brief observer-rated screening scale for depression in elderly medical patients. Age Ageing. 2000 Nov;29(6):511-5. doi: 10.1093/ageing/29.6.511.

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Koorenhof L, Baxendale S, Smith N, Thompson P. Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: a preliminary report. Seizure. 2012 Apr;21(3):178-82. doi: 10.1016/j.seizure.2011.12.001. Epub 2011 Dec 23.

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Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

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Ouellet MC, Morin CM. Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. Arch Phys Med Rehabil. 2007 Dec;88(12):1581-92. doi: 10.1016/j.apmr.2007.09.006.

Reference Type BACKGROUND
PMID: 18047872 (View on PubMed)

Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Aphasiology. 2016 Jul 2;30(7):862-876. doi: 10.1080/02687038.2016.1178022. Epub 2016 Apr 29.

Reference Type BACKGROUND
PMID: 27279674 (View on PubMed)

Tunnard C, Wilson BA. Comparison of neuropsychological rehabilitation techniques for unilateral neglect: an ABACADAEAF single-case experimental design. Neuropsychol Rehabil. 2014;24(3-4):382-99. doi: 10.1080/09602011.2013.872041. Epub 2014 Jan 13.

Reference Type BACKGROUND
PMID: 24410191 (View on PubMed)

Ayerbe L, Ayis S, Wolfe CD, Rudd AG. Natural history, predictors and outcomes of depression after stroke: systematic review and meta-analysis. Br J Psychiatry. 2013 Jan;202(1):14-21. doi: 10.1192/bjp.bp.111.107664.

Reference Type RESULT
PMID: 23284148 (View on PubMed)

Baylan S, McGinlay M, MacDonald M, Easto J, Cullen B, Haig C, Mercer SW, Murray H, Quinn TJ, Stott D, Broomfield NM, Stiles C, Evans JJ. Participants' experiences of music, mindful music, and audiobook listening interventions for people recovering from stroke. Ann N Y Acad Sci. 2018 May 4. doi: 10.1111/nyas.13618. Online ahead of print.

Reference Type RESULT
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Baylan S, Swann-Price R, Peryer G, Quinn T. The effects of music listening interventions on cognition and mood post-stroke: a systematic review. Expert Rev Neurother. 2016 Nov;16(11):1241-1249. doi: 10.1080/14737175.2016.1227241. Epub 2016 Aug 29.

Reference Type RESULT
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Cumming TB, Churilov L, Linden T, Bernhardt J. Montreal Cognitive Assessment and Mini-Mental State Examination are both valid cognitive tools in stroke. Acta Neurol Scand. 2013 Aug;128(2):122-9. doi: 10.1111/ane.12084. Epub 2013 Feb 21.

Reference Type RESULT
PMID: 23425001 (View on PubMed)

Maclean N, Pound P, Wolfe C, Rudd A. Qualitative analysis of stroke patients' motivation for rehabilitation. BMJ. 2000 Oct 28;321(7268):1051-4. doi: 10.1136/bmj.321.7268.1051.

Reference Type RESULT
PMID: 11053175 (View on PubMed)

McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24.

Reference Type RESULT
PMID: 21441153 (View on PubMed)

Sarkamo T, Tervaniemi M, Laitinen S, Forsblom A, Soinila S, Mikkonen M, Autti T, Silvennoinen HM, Erkkila J, Laine M, Peretz I, Hietanen M. Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain. 2008 Mar;131(Pt 3):866-76. doi: 10.1093/brain/awn013.

Reference Type RESULT
PMID: 18287122 (View on PubMed)

Skidmore ER, Whyte EM, Holm MB, Becker JT, Butters MA, Dew MA, Munin MC, Lenze EJ. Cognitive and affective predictors of rehabilitation participation after stroke. Arch Phys Med Rehabil. 2010 Feb;91(2):203-7. doi: 10.1016/j.apmr.2009.10.026.

Reference Type RESULT
PMID: 20159122 (View on PubMed)

Related Links

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Other Identifiers

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261210

Identifier Type: -

Identifier Source: org_study_id

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