The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus Handicap, Psychological Factors, and Sleep Quality in Tinnitus Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Trait Anxiety Scale (TAS)
研究概览
简要总结
The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.
There will be a parallel-group randomized controlled trial study and consists of two groups.
Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application.
详细描述
The aim of this study is to evaluate the effect of 4-7-8 breathing exercise technique on tinnitus handicap, psychological factors and sleep quality. It is also aimed to compare the results of the experimental group and those who received only 1 hour of informative session on tinnitus (Control group).
The study will employ a parallel-group randomized controlled trial design. Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks.
Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory,and perceived stress scale will be applied to all patients before and after the application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
In the study, patients do not know which group they were in. Therefore, blinding is performed among the participants. To prevent bias in the study, blinding is also performed between the researchers. Researchers (S.B. and A.O. from both clinics) make the pre- and post-test evaluations without knowing which group the patients are in.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-65 years with subjective idiopathic tinnitus complaints for at least six months
- •Must be able to speak and read Turkish
- •Must be able to answer the questionnaire questions and perform the 4-7-8 breathing exercises regularly
排除标准
- •Any neuro-otologic, psychiatric, neurologic, or cognitive problems, objective tinnitus, chronic medication use, asthma diagnosis or respiratory distress
- •Receivement of any tinnitus treatment or tinnitus informative session actively
结局指标
主要结局
Trait Anxiety Scale (TAS)
时间窗: Six weeks after baseline evaluation
The trait anxiety subscale of the State-Trait Anxiety Inventory was used to assess the level of anxiety in those with tinnitus. The TAS is a 4-point Likert-type scale consisting of twenty items that aims to determine how the individual feels regardless of the situation and conditions in which they find themselves. A score between 20 and 80 is obtained from this scale. Higher scores indicate higher level of anxiety. A score between 20 and 80 is obtained from this scale. All patients will be assessed six weeks after baseline evaluation.
Visual Analog Scale (VAS)
时间窗: Six weeks after baseline evaluation
Patients will be asked to assess the degree of distress and annoyance associated with their tinnitus, as well as its severity, using a Visual Analog Scale (VAS) from 0 to 10 both before and after the application. An increase in these areas is shown by an increase in the score. Minimum score value is 0 and maximum value is 10. All patients will be assessed six weeks after baseline evaluation.
Tinnitus Handicap Inventory (THI)
时间窗: Six weeks after baseline evaluation
The Tinnitus Handicap Inventory (THI) assesses the catastrophic, emotional, and functional impacts of tinnitus and measures its effects on patients' daily functioning. The THI consists of 25 items. In the inventory, there are 25 items consisting of three options as 'yes', 'no', and 'sometimes'. A 'yes' answer is worth 4 points and a 'no' answer is worth 0 points. A maximum score of 100 points can be obtained from the THI. The higher the score, the greater the perception of the tinnitus as a handicap. Minimum score value is 0 and maximum value is 100. All patients will be assessed six weeks after baseline evaluation.
Insomnia severity index (ISI)
时间窗: Six weeks after baseline evaluation
Sleep quality of the patients was assessed with the insomnia severity index (ISI). It is a questionnaire that evaluates the difficulties experienced in transitioning to and maintaining sleep, the level of stress caused by sleep problems, and impairments in daily functions, and thus determines the level of insomnia. It consists of 7 questions in total. Higher score indicates more insomnia symptoms. Minimum score value is 0 and maximum value is 28. All patients will be assessed six weeks after baseline evaluation.
Perceived stress scale -10 (PSS-10)
时间窗: Six weeks after baseline evaluation
The Perceived Stress Scale-10 (PSS-10) will be administered to assess the stress perceived by tinnitus patients. It was developed to measure the extent to which situations in one's life are considered stressful. It consists of 10 questions. The scores of PSS-10 vary between 0 and 40. Greater perceived stress is indicated by higher scores. The scores of PSS-10 vary between 0 and 40. All patients will be assessed six weeks after baseline evaluation.
次要结局
未报告次要终点