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临床试验/CTRI/2025/10/096550
CTRI/2025/10/096550
尚未招募
不适用

Impact of Menopausal Transition and Postmenopause on Physical and Mental Health and Its Association with the Quality of Life: A Cross-Sectional Study.

School of Physiotherapy1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年11月8日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
School of Physiotherapy
入组人数
90
试验地点
1
主要终点
Psychological, somato-vegetative, and urogenital sub-scale.

概览

简要总结

Menopause is permanent cessation of menses for a year due to loss of ovarian follicular activity due to estrogen deficiency and not associated to any pathology. Premenopause is a period of regular or irregular menses before menopause or perimenopause when the female is still capable of reproduction. Perimenopause is a period from immediately prior to menopause (when biological, endocrinological & clinical features begin) to at least one year after menopause. Postmenopause is the period after the menopause. Menopause transition is a period starting from first irregular menses or skipped menstrual period to final menstrual period. Menopause Transition is associated with a lot of changes: Hormonal changes, particularly the decline in estrogen, are linked to symptoms such as hot flashes, fatigue, musculoskeletal pain, anxiety, depression, and sleep disturbances, and other changes like reproductive status, appearance, bodily functions, expectations, social circumstances, & relationships. These, in turn, can affect a woman’s quality of life (QOL)  The menopause transition is roughly divided into 2 phases, which are initially based on menstrual patterns. The early transition is characterized by a small increase in prevalence of common menstrual symptoms, but perturbation of cycles is minimal, with women having at least 1 menstrual cycle within past 3 months. A woman has entered the early menopausal transition when she experiences a >7days difference, when the interval of amenorrhea > 60 days she has entered the late menopause transition & when 12 months have passed since a woman’s last menses is the early postmenopause .Physical Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity [4]. Postmenopausal musculoskeletal pain is generally associated with reduction of the ovarian function, where there is decline in the production of mainly estrogen hormone. Estrogen deficiency leads to increased cartilage wear and tear and joint surface erosion, reduction in bone mineral density, loss of muscle mass and strength, decrease in the collagen content of connective tissues which further leads to impairment in the muscle performance and functional capacity.The current study seeks to evaluate the physical and mental health status of women during the menopausal transition and postmenopause and explore its association with quality of life using validated assessment tools. The study will also examine factors like physical activity levels and body mass index (BMI) that may modify these associations.

Aim of the study: To assess the physical and mental health status of women during the menopausal transition and postmenopause and determine its association with quality of life.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • 1.Women aged 40-55 years.
  • 2.Pre, Perimenopausal and postmenopausal women as defined by STRAW+10 criteria.
  • 3.Willingness to provide informed consent.

排除标准

  • 1.Women who have undergone HRT/ surgical menopause in last 6 months 2.History of psychiatric illness.
  • 3.Women with major medical conditions (e.g., cancer, stroke) affecting QOL.
  • 4.Women who are unable to complete the questionnaires.

结局指标

主要结局

Psychological, somato-vegetative, and urogenital sub-scale.

时间窗: Only one time assessment using the scales

2.Participation Scale (Short Version)

时间窗: Only one time assessment using the scales

3.Menopause Quality of Life

时间窗: Only one time assessment using the scales

4.IPAQ (International Physical Activity Questionnaire)

时间窗: Only one time assessment using the scales

1.Menopause rating Scale: Three independent dimensions are assessed:

时间窗: Only one time assessment using the scales

次要结局

未报告次要终点

研究者

发起方
School of Physiotherapy
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anu Arora

School of Physiotherapy, D.Y.Patil Deemed to be University, Nerul

研究点 (1)

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