The Effect of Non Invasive Stellate Ganglion Disrupting on Sleep Disturbances on Postmenopausal Female
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change of estradiole plasma level
研究概览
简要总结
The goal of this clinical trial is to asses the effect of non invasive stellate ganglion disrupting on sleep distyrbances on postmenopausal female .
The primary hypothesis:
There is no effect of noninvasive stellate ganglion disrupting on sleep disturbance parameters of postmenopausal women.
There is no effect of noninvasive stellate ganglion disrupting on quality of female's life
Non invasive stellate ganglion disrupting with physical modality TENS will be applied on participants of study group. The participants will be screened for estradiol level and assed for the quality of sleep by specialized questionnaire.
详细描述
This study will be conducted on 32 postmenopausal women referred by physicians having sleep disturbances. They will be recruited from kafr el-zayat General Hospital, El-gharbia Governorate, Egypt.
All participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in this study. The protocol will be sent for approval the ethical committee of the faculty of Physical Therapy kafrelshekh University.
The subjects will be divided randomly into two groups equal in number, study group (group A) and control group (group B):
- Study group (group A): This group will consist of sixteen women complaining from sleep disturbance with post menopause who will receive TENS (Frequency 80 _100 Hz), (Pulse duration: 150-200 μs, Pain-free stimulation intensity), (Duration;30 min).
- Control group (group B): This group will consist of sixteen women complaining from sleep disturbance with post menopause.
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
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women who are firstly have sleep disturbances.
- •Their ages will range from 50- 65 years old.
- •All patients will be medically stable when attending the study.
排除标准
- •Women will be excluded from study if:
- •Women with Impaired consciousness.
- •Inability to communicate with the paramedic because of insufficient language skills.
- •receiving any medication for sleep disturbances.
- •Patients who already have sleep disturbances due to another pathological reason or taking any medications which directly affect sleep.
- •Patients with psychological diseases.
- •Women who have any cancer diseases.
- •Diabetic and patient with cardiovascular disease.
研究组 & 干预措施
Group 1
TENS Application
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Group 1
TENS Application
干预措施: Lactium (Dietary Supplement)
Group 2
Lactium
干预措施: Lactium (Dietary Supplement)
结局指标
主要结局
Change of estradiole plasma level
时间窗: After 3 months of treatment
by biochemical examination of estradiole plasma level
Change of sleep quality
时间窗: After 3 months of treatment
By assesment of the global pittsburgh sleep quality index scores a self-rated sleep questionnaire, were used to measure the quality of sleep. There are seven different parts that add up to a total of 19 questions. The scores range from 0 (no difficulty) to 3 (severe difficulty). The components include subjective sleep quality, sleep latency, length, and normal efficiency of sleep; they also include sleep disruptions, use of sleep medications, and dysfunction during the day. The seven component scores are also added together to create a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. A score of more than 5 indicates a clinical sleep disability.
Change of estradiole plasma level
时间窗: After 3 months of treatment
by biochemical examination of estradiole plasma level
Change of sleep quality
时间窗: After 3 months of treatment
By assesment of the global pittsburgh sleep quality index scores a self-rated sleep questionnaire, were used to measure the quality of sleep. There are seven different parts that add up to a total of 19 questions. The scores range from 0 (no difficulty) to 3 (severe difficulty). The components include subjective sleep quality, sleep latency, length, and normal efficiency of sleep; they also include sleep disruptions, use of sleep medications, and dysfunction during the day. The seven component scores are also added together to create a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. A score of more than 5 indicates a clinical sleep disability.
次要结局
未报告次要终点
研究者
Wafaa Shaaban Hassan Elbeltagy
Senior physical therapist
Kafrelsheikh University