Clincosm LogoSign in Get a demo

Music Listening for Wellbeing in Adults With Acquired Visual Impairment

Sponsor
Anglia Ruskin University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05243732
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
6.5
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindful Music Listening
  • Behavioral: Music Listening
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Feasibility and acceptability pre/post-test designFeasibility and acceptability pre/post-test design
Masking:
Single (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.
Primary Purpose:
Other
Official Title:
Music Listening for Psychological and Emotional Wellbeing in Adults With Acquired Visual Impairment: a Feasibility Study
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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.

Behavioral: Mindful Music Listening
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.

Behavioral: Music Listening
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

Outcome Measures

Primary Outcome Measures

  1. Feasibility of the intervention [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 [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 [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 [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 [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 [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 [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 [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 Outcome Measures

  1. Changes in Depression levels [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Vision and Hearing Sciences Cambridge United Kingdom CB1 1PT

Sponsors and Collaborators

  • Anglia Ruskin University

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Anglia Ruskin University
ClinicalTrials.gov Identifier:
NCT05243732
Other Study ID Numbers:
  • 1021-07
First Posted:
Feb 17, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vision Disorders
Vision, Low

Study Results

No Results Posted as of May 19, 2022