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临床试验/NCT05243732
NCT05243732已完成不适用

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

Anglia Ruskin University2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
Feasibility of the intervention

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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+)

排除标准

  • 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.

结局指标

主要结局

Feasibility of the intervention

时间窗: 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.

To understand the reasons for attrition rate of the intervention

时间窗: 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.

Acceptability of the intervention

时间窗: 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.

Treatment adherence at 4-weeks from baseline

时间窗: 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.

To identify reasons for motivation or barriers to adherence

时间窗: 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.

Attrition rate of the intervention

时间窗: Week 5 (Post Intervention)

The percentage of recruited participants dropped out from the study prematurely

Adherence to submission of a music listening diary log

时间窗: 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.

Accessibility of the intervention

时间窗: 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.

次要结局

  • Changes in Anxiety levels(Baseline and Week 5 (Pre and Post Intervention))
  • Changes in Depression levels(Baseline and Week 5 (Pre and Post Intervention))
  • Changes in Stress levels(Baseline and Week 5 (Pre and Post Intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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