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临床试验/NCT06154798
NCT06154798已完成不适用

Effectiveness of World Digital Detox Program on Psychological Distress, Psychosocial Factors, Menopause Symptoms, and Physical Health Outcome in Women: Pragmatic Randomized Controlled Trial

Innowage Limited1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Menopausal Health-Related Quality of Life

研究概览

简要总结

The concept of a digital detox, involving a deliberate reduction or elimination of digital device usage, has emerged as a potential strategy to mitigate the adverse effects of technology on mental and physical well-being. However, the specific effects of a structured digital detox program on psychological distress, psychosocial factors, menopause symptoms, and overall physical health in a community context remain underexplored.

This study seeks to address this gap by conducting a real-world trial, examining the impact of a digital detox program tailored for women. By delving into the intricacies of how digital technology interacts with the unique challenges faced by women, this research aims to contribute valuable insights into the development of real-world-driven interventions that promote the holistic well-being of women in the digital age.

详细描述

Excessive screen time and social media use during menopause pose multifaceted challenges. Prolonged exposure to screens can disrupt sleep patterns and exacerbate existing sleep disturbances, impacting the hormonal balance crucial for menopausal women. Social media's potential to induce stress, anxiety, and negative self-perception adds an emotional layer, while sedentary screen-related behavior may contribute to physical health concerns such as weight gain and decreased bone density, issues already pertinent to menopausal women. The impact on interpersonal relationships, cognitive function, body image, and time management further complicates the landscape, highlighting the need for mindful strategies to navigate the intersection of menopause and digital habits.

The World Digital Detox Program, developed by the Zep Foundation, takes a comprehensive approach to address challenges associated with increased screen and social media use, extending its focus to encompass the unique challenges faced by women during menopause. The concept of a digital detox, involving a deliberate reduction or elimination of digital device usage, has emerged as a potential strategy to mitigate the adverse effects of technology on mental and physical well-being.

The overarching aim is to enhance the comprehensive well-being of women in the digital era, going beyond addressing broad concerns of prolonged screen usage. The focus is on tailoring interventions to meet the distinct needs of women navigating the complexities of menopause. This involves incorporating practices such as breathwork, exercise, dietary adjustments, and overall well-being strategies, ensuring a holistic approach that considers the unique challenges and requirements of women during this life stage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Menopausal staging: perimenopause or postmenopausal as per STRAW definitions
  • Speak, read, and write in English sufficiently to comprehend materials in group treatment.

排除标准

  • Participants who are severely depressed
  • Need for acute treatment
  • Participants with Psychotic Disorders, or current Substance Dependence.
  • On Hormonal Replacement Therapy or intent to in next 3-months

结局指标

主要结局

Menopausal Health-Related Quality of Life

时间窗: Baseline to 6-weeks post intervention

Menopausal Health-Related Quality of Life -38 items questionnaire score on a 4-point or binary scale covering 4 major domains (physical health, mental health, life satisfaction, and social involvement) of a woman's health during the menopausal transition

次要结局

  • Client Satisfaction Questionnaire (CSQ)(Baseline to 6-weeks post intervention)
  • Clinical Global Impression Scale (CGI)(Baseline to 6-weeks post intervention)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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