Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient reported hot flashes questionnaire
研究概览
简要总结
The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes.
详细描述
There are several conflicting reports surrounding the efficacy of acupuncture for hot flashes, and several reviews exist. For example, in 2009 there were 2 reviews of acupuncture for hot flashes was performed. One evaluated 6 randomized controlled trials conducted in women without cancer. The second evaluated 6 randomized controlled trials performed in women with breast cancer.
Conclusions in 2 reviews were that existing studies suffered from methodological weaknesses, major limitation of our study due to the small size of the group, the psycho physiological, social and culture level of each woman. and there was an overall lack of supporting evidence for the use of acupuncture for the treatment of hot flashes in these population.
From previous studies , there was lack studies about effect of acupuncture on postmenopausal hot flashes.
So this study end to investigate the effect of high power laser acupuncture on postmenopausal hot flashes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sixty post menopausal women suffering from hot flashes.
- •Their age will range from 50 to 60 years.
- •Their body mass index (BMI) will range(> 30kg/m2).
排除标准
- •Breast cancer.
- •Myocardial infarction.
- •Pulmonary embolism.
研究组 & 干预措施
High power laser acupuncture + Paced respiration exercise
This group will consist of 30 postmenopausal women, who will receive High power laser acupuncture and paced respiration exercise for 15 minutes/sessions, 3 times/week for 4 weeks.
干预措施: High power laser acupuncture (Device)
High power laser acupuncture + Paced respiration exercise
This group will consist of 30 postmenopausal women, who will receive High power laser acupuncture and paced respiration exercise for 15 minutes/sessions, 3 times/week for 4 weeks.
干预措施: Paced Respiration Exercise (Other)
Placebo High power laser acupuncture + Paced respiration exercise
This group will consist of 30 post menopausal women, who will receive placebo High power laser acupuncture and paced respiration exercise for 15 minutes /sessions, 3 times/ week for 4 weeks.
干预措施: Placebo High power laser acupuncture (Other)
Placebo High power laser acupuncture + Paced respiration exercise
This group will consist of 30 post menopausal women, who will receive placebo High power laser acupuncture and paced respiration exercise for 15 minutes /sessions, 3 times/ week for 4 weeks.
干预措施: Paced Respiration Exercise (Other)
结局指标
主要结局
Patient reported hot flashes questionnaire
时间窗: 4 weeks
It will be used to determine the level of the hot flashes for each post menopausal women before starting as well as after the end of the study. Patient reported hot flashes questionnaire used to measure hot flashes frequency during the day and night .Hot flashes questionnaire score ranged from 0 (Not at all) to 10(very much). The numbers from 0 to 10 indicate the average amount of hot flashes which bothers the patient. This questionnaire include questions about number of hot flashes during day, number of hot flashes during night and duration of single hot flashes episode.
次要结局
- Follicular stimulating hormone analysis(4 weeks)
研究者
Eman Saeed Mohamed Elgohary
Principal Investigator
Cairo University