Investigation of the Physical and Psychosocial Status and Quality of Life of People With Meniere's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Evaluation of the range of motion (ROM) in the cervical region muscles with the "Cervical Range of Motion" (CROM) device
研究概览
简要总结
The aim of our study is to determine the severity of the disease in people with Meniere's Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy volunteers.
详细描述
Meniere's disease (MD) is an inner ear disease characterized by independent attacks and lasting for at least 20 minutes, dizziness, recurrent hearing loss during seizures, tinnitus, fullness in the ear, and a feeling of headache. After the diagnosis of the disease, the most disturbing situation for the patient is the uncertainty of the progression of the disease and the deterioration of the quality of life. It is very difficult to know and predict how the disease will progress. Quality of life is impaired by current symptoms and may be further reduced by uncertainty about when another attack may occur and activity restriction due to fear of provoking symptoms with exertion or stress.
When the studies on MD are examined, it is seen that the symptoms affect not only certain physical conditions but also psychological conditions. It has been observed that psychological factors play a more important role than is commonly realized in terms of their impact on patients' quality of life. MD has a negative impact on the person's daily life, and the person avoids certain daily activities or situations because of the illness. Looking at the literature, it is not known whether the severity of disease symptoms or whether the psychological state precedes the physical state.
In light of all this information, MD appears to be a multifaceted condition that can have major and often alarming effects on the lives of affected individuals. Therefore, it is important to evaluate individuals with MD with a holistic approach.
The aim of our study is to determine the severity of the disease in people with Meniere's Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •Having been diagnosed with Meniere's disease as a result of clinical and audiological evaluation by an ENT specialist
- •ability to read and write
- •be between the ages of 18-65
- •Not having an acute attack and not receiving acute attack treatment during the study period,
- •Having given consent to participate in the study as a result of the information
- •A minimum score of 24 on the Mini Mental Test (MMDT)
- •Study group
排除标准
- •Known neurological disease (head trauma, spinal trauma, multiple sclerosis, intracranial tumor, etc.) Having an anatomical problem or disease related to the outer and middle ear
- •Peripheral and central vestibular pathology other than Meniere's disease
- •Sensorineural hearing loss due to other causes
- •Other neurological, orthopedic, circulatory system or vision problems that may cause vertigo, dizziness and balance disorder
- •Control group Inclusion Criteria:
- •ability to read and write
- •be between the ages of 18-65
- •Not having an acute attack and not receiving acute attack treatment during the study period,
- •Having given consent to participate in the study as a result of the information
- •A minimum score of 24 on the Mini Mental Test (MMDT)
- •without vertigo
- •Control group Exclusion Criteria:
- •suffering from vertigo
- •Known neurological disease (head trauma, spinal trauma, multiple sclerosis, intracranial tumor, etc.) Having an anatomical problem or disease related to the outer and middle ear
- •Peripheral and central vestibular pathology other than Meniere's disease
- •Sensorineural hearing loss due to other causes
- •Other neurological, orthopedic, circulatory system or vision problems that may cause vertigo, dizziness and balance disorder
结局指标
主要结局
Evaluation of the range of motion (ROM) in the cervical region muscles with the "Cervical Range of Motion" (CROM) device
时间窗: March 2023-May 2023
"Cervical Range of Motion" (CROM) device was used to evaluate the range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
Evaluation of the anterior tilt angle of the head
时间窗: March 2023- May 2023
Anterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7.
Evaluating the sense of proprioception with the "Cervical Range of Motion" (CROM) device
时间窗: March 2023- May 2023
"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
Evaluation of postural balance with the Freemed pressure platform
时间窗: March 2023- May 2023
Postural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable.
Static balance assessment with tandem stance test
时间窗: March 2023- May 2023
In our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed.
Dynamic balance assessment with tandem gait test
时间窗: March 2023- May 2023
In our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open.
Temporomandibular joint range of motion assessment
时间窗: March 2023- May 2023
In our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation.
Posture evaluation with New York posture analysis
时间窗: March 2023- May 2023
The New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65.
Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
时间窗: March 2023- May 2023
In our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides.
Evaluation of quality of life with short form-12 (SF-12)
时间窗: March 2023- May 2023
The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life.
Headache presence and severity assessment
时间窗: March 2023- May 2023
The participant was asked to mark the places where the headache occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Evaluation of anxiety-depression status with hospital anxiety and depression scale
时间窗: March 2023- May 2023
The Hospital Anxiety and Depression Scale was used to evaluate the anxiety and depression status of the individuals participating in our study. The participant answers with a four-point (0-3 point) response option for each item. Therefore, according to the answers given, the possible score probabilities are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, and the cut-off point for the depression subscale is 7 points. The higher the total score, the higher the level of depression and anxiety.
Craniocervical pain presence and severity assessment
时间窗: March 2023-May 2023
The participant was asked to mark the areas of craniocervical pain from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Temporomandibular pain presence and severity assessment
时间窗: March 2023-May 2023
The participant was asked to mark the places where temporomandibular pain occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.
Evaluation of sleep quality with the Pittsburgh sleep quality index
时间窗: March 2023- May 2023
The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality and discomfort of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant answers each item between 0-3 points according to the frequency. The total score (0-21 points) from these components indicates whether the sleep quality is good or not. As the total score increases, sleep quality decreases and sleep disorder status increases. A total score of 5 or more indicates poor sleep quality.
Evaluation of fatigue with the fatigue severity scale
时间窗: March 2023- May 2023
The Fatigue Severity Scale was used to evaluate the fatigue status of the individuals participating in our study. The Fatigue Severity Scale uses a scoring system ranging from 1-7, starting with disagree (1 point) and gradually increasing to agree (7 points). It consists of 9 items in total and people mark the option that suits them. Possibilities of total points that can be taken vary between 9-63 points. A score of 36 and above indicates that the level of fatigue is severe. The higher the score, the higher the level of fatigue.
the International Fall Efficiency Scale
时间窗: March 2023- May 2023
The International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 to 64.
次要结局
- A feeling of fullness and/or pressure in the ear(March 2023- May 2023)
- Tinnitus disability scale(March 2023- May 2023)
- Dizziness intensity and frequency(March 2023- May 2023)
- International physical activity questionnaire-measurement of physical activity level with short(March 2023- May 2023)
- Assessment of muscle strength(March 2023- May 2023)
- Dizziness disability inventory(March 2023- May 2023)
- Vertigo symptom scale-short form(March 2023- May 2023)
- Hearing Impairment Scale(March 2023- May 2023)
- Evaluation of muscle endurance(March 2023- May 2023)
研究者
Gülistan Örenç
Physiotherapist (Student in Graduate School of Health Sciences)
Hacettepe University