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Visual ImpairmentNCT05243732

Music Listening for Wellbeing in Adults With Acquired Visual Impairment

A study testing Mindful Music Listening and Music Listening in people with Visual Impairment and Low Vision, run by Anglia Ruskin University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A visual impairment (VI) is often associated with reduced psychological wellbeing. Music can be used in a variety of ways to promote psychological wellbeing. Music intervention studies demonstrate that listening to music can provide a distraction from unpleasant thoughts/feelings. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Visual Impairment, Low Vision, Depression
What is being tested?
Mindful Music Listening and Music Listening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited Kingdom
Study dates
15 Jan 2022to 1 Dec 2022
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

  • Age 18+
  • Have an acquired vision loss (someone who was not born with vision loss but lost part or all of their vision later in life)
  • Have an existing account on a online streaming platform to listen to music
  • Own a smartphone/tablet or technology that supports their music streaming platform
  • Have the capacity to consent
  • Have at least mild symptoms on the Depression Anxiety Stress Scale (DASS-21) screening questionnaire; depression (score: 10 or higher on a scale 0-28+) and/or anxiety (score: 8 or higher on a scale 0-20+) and/or stress (score: 15 or higher on a scale 0-34+)

Who cannot join

  • Anyone who has a hearing impairment that renders the individual unable to listen to music or mindfulness instructions and follow a conversation on the telephone.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Department of Vision and Hearing Sciences

    Cambridge, CB1 1PT

Other trials in United Kingdom

About this study

Official title: Music Listening for Psychological and Emotional Wellbeing in Adults With Acquired Visual Impairment: a Feasibility Study

A visual impairment (VI) is often associated with reduced psychological wellbeing. Music can be used in a variety of ways to promote psychological wellbeing. Music intervention studies demonstrate that listening to music can provide a distraction from unpleasant thoughts/feelings. Hence, music may serve as a catalyst to improve mood and relieve feelings of depression, anxiety, and stress.

The purpose of this study is to investigate if it is feasible for people with acquired VI to self-deliver daily music listening (music alone or with mindful music listening instructions) for wellbeing, in participants homes, for four-weeks, and to collect data remotely on efficacy in reducing symptoms of anxiety and depression and treatment fidelity.

Read the detailed description

Detailed Description:

As part of the study participants will be asked to:

  • listen to music online at home (for example streaming music using Apple Music, Spotify or the provider participants have an existing account with) for up to one-hour each day, five days a week for four-weeks.
  • complete a listening diary log each day (10 minutes duration approximately). This provides an opportunity for participants to record their feelings and emotions after every listening exercise.
  • complete surveys to capture evaluative information before and after the four-weeks music listening trial.
  • part take in a series of one-to-one consultations via Zoom/MS Teams (video optional) on creating a personalised playlist for each participant, technical and instructional training and follow up progress.
  • optional one-to-one interview via Zoom/MS Teams (video optional) on feedback and experience of this daily music listening research study (10 minutes duration approximately).
Being tested
Mindful Music Listening, Music Listening
Medical subject headings
Vision Disorders, Vision, Low, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful Music ListeningBehavioural

    Participants will be instructed to self-administer this intervention daily, five days a week, for four weeks, 20 to 60 minutes per day at any time that is convenient for them.

    During the intervention period, participants will be recommended to listen to music in a private setting that is quiet, where they will not be disturbed or distracted so they can fully focus on the music.

    Participants in the mindful listening group will be given specific instructions on how to listen and follow mindfulness.

  • Music ListeningBehavioural

    Participants will be instructed to self-administer this intervention daily, five days a week, for four weeks, 20 to 60 minutes per day at any time that is convenient for them.

    During the intervention period, participants will be recommended to listen to music in a private setting that is quiet, where they will not be disturbed or distracted so they can fully focus on the music. No other specific music listening instructions will be given

Study groups in NCT05243732
Study groupRoleWhat they receive
Mindful Music ListeningExperimentalParticipants in the mindful music listening group, will receive personalised music playlists based on music tracks or albums or genres suggested by the participant in the pre-intervention survey. The playlist will be created on the streaming platform they are subscribed to. In addition to listening to their preferred music daily, they will be emailed a brief mindful music exercise to complete prior to listening to their preferred music playlist (weeks 1-4). The mindful music exercise will have spoken instructions, and focus on key element of mindfulness of paying attention to the present moment. For example, If participants were to notice any thoughts or sensations arising either during the brief exercise or during subsequent music listening, they are to allow them to pass and to gently bring their attention back to the exercise/music.
Receives: Behavioral: Mindful Music Listening
Music ListeningActive comparatorParticipants in the music listening group will receive personalised playlists based on music tracks or albums or genres suggested by the participant in the pre-intervention survey. The playlist will be created on the streaming platform they are subscribed to. In contrast to the mindful-music condition, no specific listening instructions will be given to the music listening only condition.
Receives: Behavioral: Music Listening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the intervention

    Feasibility of the intervention will be reported as the percentage of participants who enrol and complete the entire study.

    Measured: At baseline to Week 5 (Pre to Post intervention)

  2. Attrition rate of the intervention

    The percentage of recruited participants dropped out from the study prematurely

    Measured: Week 5 (Post Intervention)

  3. To understand the reasons for attrition rate of the intervention

    Qualitative methods will be utilised to identify reasons the recruited participants dropped out from the study prematurely via free text comment boxes on the evaluation survey and optional semi-structured interviews.

    Measured: Week 5 (Post Intervention)

  4. Acceptability of the intervention

    Acceptability will be defined as participant's evaluation of the online intervention using both qualitative and quantitative methods. The acceptability of the intervention will be reported as the percentage of participants who evaluated the intervention and score it 5 being "acceptable" in contrast to 1 being "unacceptable" on a 5-point researcher devised Likert scale. Feedback on the overall intervention will be collated through free text comment boxes on the evaluation survey and optional semi-structured interviews.

    Measured: Week 5 (Post Intervention)

  5. Accessibility of the intervention

    Accessibility will be defined as participant's evaluation of the online intervention using both qualitative and quantitative methods. The accessibility of the intervention will be reported as the percentage of participants who evaluated the intervention, and score it 5 being "very easy" in contrast to 1 being "very difficult" to use on a 5-point researcher devised Likert scale. To identify the accessibility barriers, free text comment boxes on the evaluation survey will be utilised and optional semi-structured interviews.

    Measured: Week 5 (Post Intervention)

  6. Adherence to submission of a music listening diary log

    Adherence to submission of the music listening diary log will be reported as the percentage of the participants who complete the diary log.

    Measured: Daily (Week 1 to Week 4)

  7. Treatment adherence at 4-weeks from baseline

    Treatment adherence will be reported as the percentage of the participants who complete all aspects of the study, i.e. diary log submissions, all music exercises.

    Measured: Week 1 to Week 5 (Pre intervention to Post Intervention)

  8. To identify reasons for motivation or barriers to adherence

    Qualitative methods will be utilised to identify reasons for motivation or barriers to adherence using free text comment boxes on the evaluation survey and optional semi-structured interviews.

    Measured: Week 1 to Week 5 (Pre intervention to Post Intervention)

Secondary outcomes (3)
  1. Changes in Depression levels

    Depression will be self-rated by participants using the Hospital Anxiety and Depression Scale (HADS). This is assessed on a scale 0-21, below 7 indicates normal levels, 8-10 means borderline abnormal and 11-21 infers abnormal levels of depression.

    Measured: Baseline and Week 5 (Pre and Post Intervention)

  2. Changes in Anxiety levels

    Anxiety will be self-rated by participants using the Hospital Anxiety and Depression Scale (HADS). This is assessed on a scale 0-21, below 7 indicates normal levels, 8-10 means borderline abnormal and 11-21 infers abnormal levels of anxiety.

    Measured: Baseline and Week 5 (Pre and Post Intervention)

  3. Changes in Stress levels

    Stress will be self-rated by participants using the Perceived Stress Scale (PSS-14). This is assessed on a scale 0 to 40. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.

    Measured: Baseline and Week 5 (Pre and Post Intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start15 Jan 2022
  3. Primary completion30 Aug 2022
  4. Study completion1 Dec 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Feasibility and acceptability pre/post-test design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243732
Sponsor's protocol ID
1021-07
Status last verified
May 2022
First submitted
7 Jan 2022
Last updated
6 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rafaely L, Carmel S, Bachner YG. Subjective well-being of visually impaired older adults living in the community. Aging Ment Health. 2018 Sep;22(9):1223-1231. doi: 10.1080/13607863.2017.1341469. Epub 2017 Jun 21.

    PubMed 28636409
  • Freeman EE, Munoz B, West SK, Jampel HD, Friedman DS. Glaucoma and quality of life: the Salisbury Eye Evaluation. Ophthalmology. 2008 Feb;115(2):233-8. doi: 10.1016/j.ophtha.2007.04.050. Epub 2007 Jul 26.

    PubMed 17655930
  • Broman AT, Munoz B, Rodriguez J, Sanchez R, Quigley HA, Klein R, Snyder R, West SK. The impact of visual impairment and eye disease on vision-related quality of life in a Mexican-American population: proyecto VER. Invest Ophthalmol Vis Sci. 2002 Nov;43(11):3393-8.

    PubMed 12407148
  • Matthews K, Nazroo J, Whillans J. The consequences of self-reported vision change in later-life: evidence from the English Longitudinal Study of Ageing. Public Health. 2017 Jan;142:7-14. doi: 10.1016/j.puhe.2016.09.034. Epub 2016 Nov 10.

    PubMed 28057201
  • Brown RL, Barrett AE. Visual impairment and quality of life among older adults: an examination of explanations for the relationship. J Gerontol B Psychol Sci Soc Sci. 2011 May;66(3):364-73. doi: 10.1093/geronb/gbr015. Epub 2011 Mar 14.

    PubMed 21402645
  • Rovner BW, Casten RJ. Activity loss and depression in age-related macular degeneration. Am J Geriatr Psychiatry. 2002 May-Jun;10(3):305-10.

    PubMed 11994218
  • Mojon-Azzi SM, Sousa-Poza A, Mojon DS. Impact of low vision on well-being in 10 European countries. Ophthalmologica. 2008;222(3):205-12. doi: 10.1159/000126085. Epub 2008 May 22.

    PubMed 18497531
  • Senra H, Macedo AF, Nunes N, Balaskas K, Aslam T, Costa E. Psychological and Psychosocial Interventions for Depression and Anxiety in Patients With Age-Related Macular Degeneration: A Systematic Review. Am J Geriatr Psychiatry. 2019 Aug;27(8):755-773. doi: 10.1016/j.jagp.2019.03.001. Epub 2019 Mar 7.

    PubMed 31005495
  • Chanda ML, Levitin DJ. The neurochemistry of music. Trends Cogn Sci. 2013 Apr;17(4):179-93. doi: 10.1016/j.tics.2013.02.007.

    PubMed 23541122
  • Bernatzky G, Presch M, Anderson M, Panksepp J. Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. Neurosci Biobehav Rev. 2011 Oct;35(9):1989-99. doi: 10.1016/j.neubiorev.2011.06.005. Epub 2011 Jun 16.

    PubMed 21704068
  • Linnemann A, Ditzen B, Strahler J, Doerr JM, Nater UM. Music listening as a means of stress reduction in daily life. Psychoneuroendocrinology. 2015 Oct;60:82-90. doi: 10.1016/j.psyneuen.2015.06.008. Epub 2015 Jun 21.

    PubMed 26142566
  • Blood AJ, Zatorre RJ. Intensely pleasurable responses to music correlate with activity in brain regions implicated in reward and emotion. Proc Natl Acad Sci U S A. 2001 Sep 25;98(20):11818-23. doi: 10.1073/pnas.191355898.

    PubMed 11573015
  • Somani N, Street A, Beukes EW, Zhang J, Allen PM. Music listening for psychological well-being in adults with acquired vision impairment: a feasibility randomised controlled trial. Front Psychiatry. 2025 Feb 25;16:1505283. doi: 10.3389/fpsyt.2025.1505283. eCollection 2025.

    PubMed 40071281

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Music Listening and Music Listening in people with Visual Impairment and Low Vision, run by Anglia Ruskin University at 1 site in United Kingdom.

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 6 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 6 Dec 2022. 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 United Kingdom. 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?

Feasibility of the intervention (time frame: At baseline to Week 5 (Pre to Post intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243732, which also lists 13 linked publications.

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 6 Dec 2022.

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