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Completed

NCT Number: NCT05243732

Music Listening for Wellbeing in Adults With Acquired Visual Impairment

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.

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Key information

Conditions

Visual Impairment Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Emotional Adjustment Eye Diseases Low Vision Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stress Vision Disorders Vision, Low

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vision and Hearing Sciences

Cambridge, CB1 1PT, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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+)

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. Feasibility of the intervention

    Time frame: At baseline to Week 5 (Pre to Post intervention)

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

  2. Attrition rate of the intervention

    Time frame: Week 5 (Post Intervention)

    The percentage of recruited participants dropped out from the study prematurely

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

    Time frame: Week 5 (Post 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.

  4. Acceptability of the intervention

    Time frame: Week 5 (Post 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.

  5. Accessibility of the intervention

    Time frame: Week 5 (Post 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.

  6. Adherence to submission of a music listening diary log

    Time frame: Daily (Week 1 to Week 4)

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

  7. Treatment adherence at 4-weeks from baseline

    Time frame: Week 1 to Week 5 (Pre intervention to Post Intervention)

    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.

  8. To identify reasons for motivation or barriers to adherence

    Time frame: Week 1 to Week 5 (Pre intervention to Post Intervention)

    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.

Secondary outcomes

  1. Changes in Depression levels

    Time frame: Baseline and Week 5 (Pre and Post Intervention)

    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.

  2. Changes in Anxiety levels

    Time frame: Baseline and Week 5 (Pre and Post Intervention)

    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.

  3. Changes in Stress levels

    Time frame: Baseline and Week 5 (Pre and Post Intervention)

    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.

Sponsors and collaborators

Lead sponsor

Anglia Ruskin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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