Music Listening for Wellbeing in Adults With Acquired Visual Impairment

December 5, 2022 updated by: Anglia Ruskin University

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cambridge, United Kingdom, CB1 1PT
        • Department of Vision and Hearing Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindful Music Listening

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.

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.

Active Comparator: Music Listening
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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline to Week 5 (Pre to Post intervention)
Attrition rate of the intervention
Time Frame: Week 5 (Post 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
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.
Week 5 (Post Intervention)
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.
Week 5 (Post Intervention)
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.
Week 5 (Post Intervention)
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.
Daily (Week 1 to Week 4)
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.
Week 1 to Week 5 (Pre intervention to Post Intervention)
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.
Week 1 to Week 5 (Pre intervention to Post Intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 5 (Pre and Post Intervention)
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.
Baseline and Week 5 (Pre and Post Intervention)
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.
Baseline and Week 5 (Pre and Post Intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nurbanu Somani, MSc MRes BSc, Anglia Ruskin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Mindful Music Listening

3
Subscribe