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临床试验/NCT04281225
NCT04281225撤回不适用

Mindfulness Intervention and Symptom Variability in Hearing

Harvard University2 个研究点 分布在 1 个国家开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Hearing Change - subjective preferred volume

研究概览

简要总结

The purpose of this study is to investigate the efficacy of mindfulness and placebo treatments on hearing improvement. More specifically, the researchers will be investigating whether the following variables impact the effectiveness of placebo treatment such as: mindfulness, and attention to variability. Extant research has found the effectiveness of psychological treatment in multiple domains, and the researchers look to further investigate this success in the domain of hearing symptom sensations.

详细描述

The placebo effect, described as "psychological or physiological responses attributed to expectations of an inert substance or procedure, has been demonstrated to have powerful effects in multiple instances (Colloca & Benedetti, 2005). Although research on the placebo effect is prolific, the mechanisms involved can vary based on the context and have been difficult to research with consistent approaches and results (Brown et al., 2013; Holmes et al., 2018). Some researchers have found that the mere perception of a treatment as "new" is enough to elicit a placebo effect, while others have found that the key mechanism may be attention to symptoms - nevertheless, "little evidence exists on the precise mechanisms through which psychological treatments actually work" (Brown et al., 2013; Holmes et al., 2018).

Earlier work suggests the potential for psychological treatments for hearing loss or other forms of hearing disability, including coping techniques (Scott et al, 2009). This study aims to extend the mind-body unity theory as suggested by Dawes et al. (2013) who found in two successive studies that there is a reliable placebo effect in hearing-aid trials. While the objective of these studies was to encourage double-blind methodology (to optimize results), these results suggest that such effects can optimize outcomes and as the audiology field does not typically consider placebo effects. it suggests that hearing improvements can be impacted by (positive) expectations in a "general" sense (not a specific type of hearing aid but simply a "new technology" hearing aid). While this will be of great use clinically in double blind trials, it suggests that the use of a psychological construct, specifically the Langerian attention to variability construct, can function to encourage a placebo effect or a clinical response by encouraging a sense of personal control over the symptoms of the hearing loss. In this study, researchers will look to further investigate one potential mechanism important to the placebo effect - attention to variability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

Research Assistants are blind to the conditions of the participants. Participants do not know which condition they have been assigned to either. Only the main investigators (Deb Phillips, Neha Dhawan, Kris Nichols, and Francesco Pagnini) will know which participant is assigned to a particular intervention.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18 and 80 years of age
  • Eyesight with corrective lenses sufficient enough to read and respond to emails
  • Owns or has access to and is familiar with using a smartphone and/or desk top/laptop with a cellular data plan and email host
  • Able to receive and respond to text messages and emails
  • Able to and access to watch, listen to and operate on a phone or computer a video or recording
  • English speaking and reading at 8th grade level
  • Self-Perceived mild to moderate hearing problem with onset after age 18 (adult onset)

排除标准

  • Under age 18 or over age 80
  • Unable to read and respond to texts or emails
  • No Smartphone or desktop/laptop access
  • Hearing loss onset prior to age 18
  • Co-morbid conditions such as cancer, diabetes, cardiovascular disease diagnosed and under treatment in the past 6 months
  • Pregnancy

结局指标

主要结局

Hearing Change - subjective preferred volume

时间窗: 5 minutes daily for 6 days

Participants will be told to wear the hearing device and listen to a brief audio (ballad of under 3 minutes) twice a day daily for 6 days.The survey will ask them to listen to the audio and record the volume level that they used at the beginning and at the end, and then answer a few questions after. The change in participants subjective preferred volume over the course of the week , compared to T1 at the beginning of the week, will represent hearing change.

次要结局

  • Langer Mindfulness Scale,14-Item scale(5 minutes)
  • Hearing Handicap Inventory for Adults- Screening (HHIA-S)(5 minutes)
  • Perceived Stress Scale (PSS)(5 minutes)
  • Hearing Handicap Inventory for Elderly- Screening (HHIE-S)(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Langer

Professor

Harvard University

研究点 (2)

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