Effect of Foot Reflexology Versus Acupressure on Sleep Disturbance and Hot Flashes in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
World health Organization (WHO) estimates that by 2030, 1.2 billion women will be over 50 years old. With a prevalence of 70%, a hot flash is the most distressing symptoms associated with menopause. Postmenopausal associated sleep disturbances could affect those women social activities and one's daily positive functioning. Therefore, some patients and their providers seek alternative treatments such as relaxation techniques, acupressure, yoga, reflexology, regular exercise, balanced nutrition, herbal supplements, appropriate clothing, and frequent showers, have been shown to be effective in reducing symptoms associated with depression. So, this study will be the first one in this issue. Therefore, it will have valuable benefits in physical therapy field and scientific research.
详细描述
Fifty-four postmenopausal women suffering from moderate to severe hot flashes diagnosed with hot flashes questionnaire, and sleep disturbances diagnosed with Pittsburgh quality sleep index >5. Their age ranged from 45-55 years old with their body mass index ranged from 25 to 30 kilogram per meter square. Outcome measures were Pittsburgh sleep quality index and Hot flashes questionnaire, both were conducted at baseline and after the end of the study program. after recruiting study population, they will be divided into two equal groups randomly. Group A; will received foot reflexology (medical border just above the heel, reflex points associated with adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone), for 15 minutes, 3 sessions per week for 6 weeks. Group B; will received acupressure ((Shenmen point, Sanyinjiao point, Fengchi point; Yintang point), for 21 minutes, 3 sessions per week for 6 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Each participant will have one identification number that will be used to assign participants into two equal groups in number (n=27), sequentially numbered index cards will be secured in opaque envelopes. Another assistant for the researcher will open the sealed envelope and will allocated the participants according to their groups.
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ranged from 45 to 55 years old.
- •Their body mass index ranged from 25 to 3 kilograms per meter square.
- •Postmenopausal women suffering from moderate to sever hot flashes assessed by Hot Flashes Questionnaire.
- •Postmenopausal women suffering from sleep disturbances more than five assessed by Pittsburgh sleep quality index.
排除标准
- •Any emotional stress during at least 6 months.
- •Any pharmacological medicines lead to sleep disturbances.
- •Any mental disorders affect their sleep cycle.
- •Taking hormone replacement therapy for the past six months.
- •Using herbal medicine to improve menopausal symptoms severity.
- •Circular job in particular night shifts.
- •Sensorineural problems in their feet.
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: Pretreatment and immediately Posttreatment.
A reliable, validated, self-reported questionnaire for assessing sleep quality. It is available of validated Arabic form that consists of seven components, namely, subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over a 1-month time interval. It held a good internal consistency, and convergent, also divergent validity. Each component scores are derived, each scored 'zero' means no difficulty, to 'three' means sever difficulty. component scores are summed to gain the whole score range 'zero to twenty-one' Higher scores indicates worse sleep quality.
次要结局
- Hot Flashes Questionnaire(Pretreatment and immediately Posttreatment.)
研究者
Yasmeen Samir Abdelazeem Ali
Physical Therapist Specialist
Cairo University