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临床试验/NCT06303297
NCT06303297已完成不适用

Combined Effects of Reflexology and Generalized Stretching on Insomnia, Vasomotor Symptoms and Quality of Life in Postmenopausal Females

Riphah International University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Menopause Rating Scale

研究概览

简要总结

To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females

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
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI less than 30 kg/m2
  • Residents of rural areas
  • Stable vital signs
  • Participants with natural cessation of menstrual periods for at least 12 months
  • Moderate and severe hot flash

排除标准

  • Participants with history of hysterectomy surgical menopause females
  • Participants with orthopedic disorder
  • Participants taking sleeping pills
  • Women suffer from pathological conditions for example cardiac disease, cancer impaired skin integrity
  • Participants with history of recent bone fracture
  • Severe pathology(eczema) of feet

研究组 & 干预措施

REFLEXOLOGY

Experimental

干预措施: REFLEXOLOGY (Other)

GENERALIZED STRETCHING

Active Comparator

干预措施: GENERALIZED STRETCHING (Other)

结局指标

主要结局

Menopause Rating Scale

时间窗: 3rd week

Menopause Rating Scale is a 11 items questionnaire which is use to assess vasomotor symptoms like hot flush, palpitations, sleep problem, bladder symptoms and other symptoms. Its score range is from 0 to 4, where 0 shows no complain and 4 shows severe symptoms. Its total score range is from 9 to 21, where higher the score higher are the symptoms. It has good validity and reliability. It has Cronbach alpha value of 0.86 and internal consistency of 0.81.

Insomnia severity index score

时间窗: 3rd week

This questionnaire is a 7 items questionnaire which is used to assess sleep problems. It scoring is done through Likert type scale ranging from 0 to 4, where higher score represents higher sleep problem. Its score is range from 0 to 28 where 0 to 7 shows no clinically significant insomnia, 8 to 14 shows subthreshold insomnia, 15 to 21 shows moderate severity of insomnia and 22 to 28 shows severe severity of insomnia. It is a reliable and valid tool with internal consistency of 0.74 and correlation ranging from 0.36 to 0.54.

Menopause Specific Quality of Life

时间窗: 3rd week

Menopause specific quality of life (MENQOL) questionnaire is a 29 items questionnaire which is used to assess quality of life among menopausal women. It has further four domains vasomotor (item 1 to 3), sexual (item 27-29), psychosocial (item 4-10) and physical (item 11 to 26). It is a reliable and valid tool with Cronbach value of 0.70 and internal consistency of 0.45.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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