Effect of Health Promotion on Allergic Rhinitis by Infrared-C Ray Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- The amounts of the immunoglobulin E (IgE) level reduced after the assignment
研究概览
简要总结
Allergic rhinitis is one of the chronic illnesses. At present, the major treatments for allergic rhinitis are avoiding allergens, medical treatment and surgery. However, inadequate effects, and possible side effects of these treatments are still problems to these patients. Therefore, to find an effective non-medical and non-surgical treatment will be of great help in treating patients with allergic rhinitis.
Infrared-C (far-infrared) ray irradiation is able to promote normal operation of autonomic nervous system, to improve blood circulation and thereby assumed to relieve discomfort symptoms of patients with vascular, specific or non-specific allergic rhinitis. Consequently, infrared-C ray irradiation is expected to be effective for the treatment of allergic rhinitis.
The investigators aimed to probe the adjunct effects of infrared-C ray irradiation in terms of infrared-C hot compress in improving allergy symptoms like sneezing, rhinorrhea, nasal obstruction, nose and conjunctiva itching during a medical treatment for patients with allergic rhinitis. Moreover, the impact of infrared-C irradiation on health and life quality enhancement will also be studied.
详细描述
This is a quasi-experimental design. The study subjects are recruited from patients visited to a Ear-Nose-Throat Out Patient Department in a regional teaching hospital in south Taiwan. The sampling method is purposive sampling. The inclusion criteria are adults between 20 and 50 year-old with a definite clinical diagnosis of allergic rhinitis. Subjects were randomly divided into experimental and control groups. Thirty persons in the experimental group received both medical and infrared-C ray irradiation by hot compress as intervention. On the other hand, twenty persons in the control group took only medical treatment. Patients in experimental group received anti-histamine, steroid nasal spray and infrared-C ray irradiation for 40 minutes each time, and more than three times per week. The regions for hot compress included head, neck and shoulder, back and lower back, which covered many acupuncture points frequently used by traditional Chinese medicine for the treatment of allergic rhinitis, including point Dazhui (GV14), Dingchuan (EX-B1) , Dazhu (BL11), Fengmen (BL12), Feishu (BL13), Pishu (BL20), and Shenshu (BL23). In addition, patients also received infrared-C hot compress over face, eyes and nose during acute stage of allergic rhinitis. The investigators used a questionnaire as a pre-test to collect basic information of the subjects, and Taiwan's Sino-Nasal Outcome Test-20 (SNOT-20) nose and sinusitis evaluation form as pre-middle and post-test to evaluate the effect of the interventions. World Health Organization Quality of Life Instruments (WHOQOL-BREF) and Taiwan's concise edition of WHOQOL II questionnaire were also used as basic data collection tools for allergic rhinitis. Furthermore, blood tests for patient's serum Immunoglobulin E (IgE) and eosinophil cationic protein levels were determined before and after experiment. Pre-test for the experimental and control group was carried out before the intervention, the first post-test was performed 4 weeks later, and the second post-test was carried out 12 weeks later. Data was analyzed by SPSS 22.0 software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults that age 20 above and 50 below
- •Clinical diagnosis confirmed as allergic rhinitis
- •Conscious, no mental or cognitive impairment
- •Able to read, write or communicate in Mandarin, Taiwanese or Hakka, and agreed to participate
排除标准
- •Inflammatory skin wounds on the back of the shoulder, neck or lower back
- •Polyposis
- •Acute and chronic sinusitis
- •Vasomotor rhinitis
研究组 & 干预措施
experimental group
Received infrared-C ray irradiation by hot compress with a powered heating compress and an eye mask for 40 minutes/time/day Treated regions: eyes and nose region, back region of head, shoulder neck and low back.
Received medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
干预措施: infrared-C ray irradiation (Device)
experimental group
Received infrared-C ray irradiation by hot compress with a powered heating compress and an eye mask for 40 minutes/time/day Treated regions: eyes and nose region, back region of head, shoulder neck and low back.
Received medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
干预措施: eye mask (Device)
experimental group
Received infrared-C ray irradiation by hot compress with a powered heating compress and an eye mask for 40 minutes/time/day Treated regions: eyes and nose region, back region of head, shoulder neck and low back.
Received medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
干预措施: Xyzal Oral Product (Drug)
experimental group
Received infrared-C ray irradiation by hot compress with a powered heating compress and an eye mask for 40 minutes/time/day Treated regions: eyes and nose region, back region of head, shoulder neck and low back.
Received medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
干预措施: Fluticasone Furoate (Drug)
Control group
received only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
干预措施: Xyzal Oral Product (Drug)
Control group
received only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
干预措施: Fluticasone Furoate (Drug)
结局指标
主要结局
The amounts of the immunoglobulin E (IgE) level reduced after the assignment
时间窗: Baseline to 3 months
An immunoglobulin E (IgE) test measures the level of IgE, higher amounts of IgE antibodies found can be a sign that the body overreacts to allergens. This can lead to an allergic reaction. The level reduced means the assignment is effectively improve the symptoms of allergic rhinitis.
the Eosinophil Cationic Protein (ECP) level reduced after the assignment
时间窗: Baseline to 3 months
Measuring Eosinophil Cationic Protein (ECP) levels has been used to evaluate eosinophil-mediated allergic inflammation, asthma, and rhinitis. Levels may reflect current allergen exposure. The level reduced means the assignment is effectively improve the symptoms of allergic rhinitis.
Change in the WHOQOL-BREF questionnaire, Taiwan version
时间窗: Baseline to 3 months
To measure the following broad domains: physical health, psychological health, social relationships, and environment. Score will increase after 3 months of the assignment.
Score reduce in Taiwan's SNOT-20 nose and sinusitis evaluation form
时间窗: Baseline to 3 months
Measure of outcome in sino-nasal disorders such as sinusitis. Score will reduced after 3 months of the assignment.
次要结局
未报告次要终点