Effect of an Equalizer-modulated Auditory Intervention on the Asymmetry of Interaural Auditory Perception in Groups of Different Emotional States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months
研究概览
简要总结
This study analyzes the effect of an equalizer-modulated auditory intervention on the asymmetry of interaural auditory perception in groups with different emotional states such as well-being, anxiety, depression and mixed anxiety-depression.
详细描述
The present study follows a randomized, double-blind (investigator and outcome assessor), parallel and controlled design. The auditory intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). Participants assigned to the control group are cited to the Health centre, but they do not received any intervention. These subjects follow the same evaluation and data collection process.
Once randomized, all participants will make a first control visit in which a pure-tone audiometry was carry out and completed the various psychiatric evaluation tests to classify into different groups: Goldberg Anxiety and Depression Scale (GADS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Sociodemographic variables (age, gender, nationality, education, working status, noise exposure, use of ear protection, and present or past use of any analgesic, anxiolytic or antidepressant for longer than a week).
The study variables collected at 3 months were pure-tone audiometry (air conduction).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants not received any intervention. The researchers in charge of outcome assessment and statistical analysis are blinded to the allocation of participants
入排标准
- 年龄范围
- 31 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recruited from Health Centre Mejorada del Campo (Madrid, Spain)
排除标准
- •Having significant hearing loss
- •Having acute otological process
- •Having psychotic disease
- •Having epilepsy
- •Having serious illness
- •Having pregnancy
- •Used to try alcohol or drugs
结局指标
主要结局
Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 1000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 1500 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 1500 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 125 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 250 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 250 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 500 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 500 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 750 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 750 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 2000 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 2000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 3000 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 3000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 4000 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 4000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 6000 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 6000 Hz measured in an air conduction pure tone audiometry
Change from Baseline hearing threshold at a frequency of 8000 Hz in an air conduction pure tone audiometry at three months
时间窗: Change from Baseline hearing threshold at 3 months
Minimum number of decibels needed to hear a sound at a frequency of 8000 Hz measured in an air conduction pure tone audiometry
Anxiety and depression level on the Goldberg scale
时间窗: One month
To discriminate between these two entities. The following cut-off points were used: a total Anxiety score \> 4 detects 73% of all cases of anxiety; a total Depression score \>3 detects 82% of all cases of depression
Anxiety level on the Hamilton scale
时间窗: One month
It is a clinician-administered scale on which each item is rated from 0 to 4. It yields a score in the range of 0 to 56. The following cut-off points were used: 0-5 points (No anxiety), \>5 points (Anxiety).
Depression level on the Hamilton scale
时间窗: One month
Each item is rated on a three- or five-point scale, with a score from 0 to 2 or 0 to 4, respectively. It yields a total score in the range of 0 to 52. The following cut-off points were used to assess depression: No depression: 0-7; Depression: \>7
次要结局
- Relationship between the auditory threshold of the right and left ear at the frequency of 125 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 250 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 500 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 750 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 1000 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 1500 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 2000 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 3000 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 4000 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 6000 Hz(Three months between the first and second measure)
- Relationship between the auditory threshold of the right and left ear at the frequency of 8000 Hz(Three months between the first and second measure)
研究者
Francisco Germain
Professor
University of Alcala