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Music Listening for Wellbeing in Adults With Acquired Visual Impairment

Primary Purpose

Visual Impairment, Low Vision, Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindful Music Listening
Music Listening
Sponsored by
Anglia Ruskin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Visual Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Vision and Hearing Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindful Music Listening

Music Listening

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Feasibility of the intervention
Feasibility of the intervention will be reported as the percentage of participants who enrol and complete the entire study.
Attrition rate of the intervention
The percentage of recruited participants dropped out from the study prematurely
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 7, 2022
Last Updated
December 5, 2022
Sponsor
Anglia Ruskin University
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1. Study Identification

Unique Protocol Identification Number
NCT05243732
Brief Title
Music Listening for Wellbeing in Adults With Acquired Visual Impairment
Official Title
Music Listening for Psychological and Emotional Wellbeing in Adults With Acquired Visual Impairment: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anglia Ruskin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment, Low Vision, Depression, Anxiety, Stress, Emotional Adjustment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Feasibility and acceptability pre/post-test design
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindful Music Listening
Arm Type
Experimental
Arm Description
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.
Arm Title
Music Listening
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Music Listening
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music Listening
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of the intervention
Description
Feasibility of the intervention will be reported as the percentage of participants who enrol and complete the entire study.
Time Frame
At baseline to Week 5 (Pre to Post intervention)
Title
Attrition rate of the intervention
Description
The percentage of recruited participants dropped out from the study prematurely
Time Frame
Week 5 (Post Intervention)
Title
To understand the reasons for attrition rate of the intervention
Description
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.
Time Frame
Week 5 (Post Intervention)
Title
Acceptability of the intervention
Description
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.
Time Frame
Week 5 (Post Intervention)
Title
Accessibility of the intervention
Description
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.
Time Frame
Week 5 (Post Intervention)
Title
Adherence to submission of a music listening diary log
Description
Adherence to submission of the music listening diary log will be reported as the percentage of the participants who complete the diary log.
Time Frame
Daily (Week 1 to Week 4)
Title
Treatment adherence at 4-weeks from baseline
Description
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.
Time Frame
Week 1 to Week 5 (Pre intervention to Post Intervention)
Title
To identify reasons for motivation or barriers to adherence
Description
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.
Time Frame
Week 1 to Week 5 (Pre intervention to Post Intervention)
Secondary Outcome Measure Information:
Title
Changes in Depression levels
Description
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.
Time Frame
Baseline and Week 5 (Pre and Post Intervention)
Title
Changes in Anxiety levels
Description
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.
Time Frame
Baseline and Week 5 (Pre and Post Intervention)
Title
Changes in Stress levels
Description
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.
Time Frame
Baseline and Week 5 (Pre and Post Intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurbanu Somani, MSc MRes BSc
Organizational Affiliation
Anglia Ruskin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Vision and Hearing Sciences
City
Cambridge
ZIP/Postal Code
CB1 1PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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28636409
Citation
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Music Listening for Wellbeing in Adults With Acquired Visual Impairment

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