Effects of Music Listening on Mood in an Inpatient Rehabilitation

NCT04431362 | Unknown

• 1 other identifier: 261210
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• Change in the CORE-10 mood screen

  questionnaire measure of distress, functioning and risk

  up to 6 weeks

• Change in self-report diary

  will assess feasibility by examining how frequently the patients are listening to music

  up to 6 weeks

• Change in self-report by therapists

  Will help to assess patients' engagement in therapy before during and after intervention

  up to 6 weeks

• Change in the Montreal Cognitive Assessment

  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)

  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

  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

Study Arms (2)

Baseline

NO INTERVENTION

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

Intervention

EXPERIMENTAL

Participants will listen to music for 3 weeks.

Behavioral: Self-selected music

Interventions

Self-selected music BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Related Publications (16)

• 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.

  PMID: 17903971 BACKGROUND

• 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.

  PMID: 23399668 BACKGROUND

• 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.

  PMID: 11191243 BACKGROUND

• 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.

  PMID: 22197200 BACKGROUND

• 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.

  PMID: 29253607 BACKGROUND

• 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.

  PMID: 18047872 BACKGROUND

• 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.

  PMID: 27279674 BACKGROUND

• 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.

  PMID: 24410191 BACKGROUND

• 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.

  PMID: 23284148 RESULT

• 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.

  PMID: 29727009 RESULT

• 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.

  PMID: 27548875 RESULT

• 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.

  PMID: 23425001 RESULT

• 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.

  PMID: 11053175 RESULT

• 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.

  PMID: 21441153 RESULT

• 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.

  PMID: 18287122 RESULT

• 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.

  PMID: 20159122 RESULT

Related Links

• Neuro-rehabilitation beds open
• Assessing capacity
• Frank Cooksey Rehabilitation Unit
• Stroke

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Giulia Bellesi, DClinPsy

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Bellesi, DClinPsy

CONTACT

01689866391; giulia.bellesi@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants first complete a baseline phase before starting the intervention phase.

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: June 16, 2020
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share