Music Listening for Wellbeing in Adults With Acquired Visual Impairment

NCT05243732 | Completed

• 1 other identifier: 1021-07
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Visual Impairment; Low Vision; Depression; Anxiety; Stress; Emotional Adjustment

Outcome Measures

Primary Outcomes (8)

• Feasibility of the intervention

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

  At baseline to Week 5 (Pre to Post intervention)

• Attrition rate of the intervention

  The percentage of recruited participants dropped out from the study prematurely

  Week 5 (Post Intervention)

• 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.

  Week 5 (Post Intervention)

• 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.

  Week 5 (Post Intervention)

• 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.

  Week 5 (Post Intervention)

• 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.

  Daily (Week 1 to Week 4)

• 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.

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

• 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.

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

Secondary Outcomes (3)

• Changes in Depression levels

  Baseline and Week 5 (Pre and Post Intervention)

• Changes in Anxiety levels

  Baseline and Week 5 (Pre and Post Intervention)

• Changes in Stress levels

  Baseline and Week 5 (Pre and Post Intervention)

Study Arms (2)

Mindful Music Listening

EXPERIMENTAL

Participants 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.

Behavioral: Mindful Music Listening

Music Listening

ACTIVE COMPARATOR

Participants 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.

Behavioral: Music Listening

Interventions

Mindful Music Listening BEHAVIORAL

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.

Mindful Music Listening

Music Listening BEHAVIORAL

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

Music Listening

Eligibility Criteria

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

You may qualify if:

• 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+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anglia Ruskin University: lead

Study Sites (1)

Department of Vision and Hearing Sciences

Cambridge, CB1 1PT, United Kingdom

Location

Related Publications (13)

• 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.

  PMID: 28636409 BACKGROUND

• 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.

  PMID: 17655930 BACKGROUND

• 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.

  PMID: 12407148 BACKGROUND

• 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.

  PMID: 28057201 BACKGROUND

• 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.

  PMID: 21402645 BACKGROUND

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

  PMID: 11994218 BACKGROUND

• 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.

  PMID: 18497531 BACKGROUND

• 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.

  PMID: 31005495 BACKGROUND

• 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.

  PMID: 23541122 BACKGROUND

• 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.

  PMID: 21704068 BACKGROUND

• 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.

  PMID: 26142566 BACKGROUND

• 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.

  PMID: 11573015 BACKGROUND

• 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.

  PMID: 40071281 DERIVED

MeSH Terms

Conditions

Vision Disorders; Vision, Low; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Nurbanu Somani, MSc MRes BSc

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants will be randomised into two groups, mindful music or music listening in a 1:1 ratio using a randomisation software (https://www.randomizer.org/) and block randomisation to ensure equal distribution of groups between age and number of years living with a visual impairment. The researchers who are managing and running the study will not be blinded to the assignment of the groups. The participants will not be blinded to their allocated group, as participants would clearly know if they listened to their own preferred music alone or with mindfulness instructions. However, the researchers will blind the participants from the study hypothesis and which listening group is the control condition to minimise risk of bias.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility and acceptability pre/post-test design

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 17, 2022
• Study Start: January 15, 2022
• Primary Completion: August 30, 2022
• Study Completion: December 1, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)