Impact of Breathing Exercises and Meditation on Reducing Stress and Improving Quality of Life of Glaucoma Patients: An Electronic Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in consideration of future consequences
研究概览
简要总结
The goal of this electronic feasibility clinical trial study is to evaluate the effects of breathing and meditation techniques on stress levels in patients with glaucoma.
The main questions it aims to answer are:
- Does breathing and meditation decrease the level of stress in glaucoma patients?
- Does breathing and meditation improve disease specific quality of life in glaucoma patients
- Does breathing and meditation affect the importance that in glaucoma patients place on future consequences? Participants will participate in online session where they will be taught proper breathing and meditation technique to practice. They will also be completing online questionnaires following independent practice sessions over time.
Researchers will compare the breathing and meditation group to the usual care group to see if the outcomes are different.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with glaucoma. Being able to provide valid informed consent to participate in the research study.
- •Patients aged 40-
- •Being able to read and understand English. Having no significant self-reported or physician-diagnosed mental health disorder.
- •Independent access to a computer to participate in virtual sessions. Must be able to sit comfortably for 30-35 minutes without any major pain or discomfort, can hear well enough to follow verbal instructions when the eyes are closed, and be in good general physical health.
排除标准
- •Inability to provide valid informed consent. Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
- •Having a lifetime diagnosis of self-reported other serious mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
- •Self-reported substance abuse or dependence within the past 3 months. Having acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
- •Having irreversible vision loss that prevents one from completing the questionnaires.
- •Participation in a study involving similar techniques.
结局指标
主要结局
Change in consideration of future consequences
时间窗: Baseline visit, Week 1, Week 3, Week 6, Week 12
Consideration of Future Consequences scale (CFC-10). The total score can range from 10 to 50, with higher scores indicating a stronger consideration of future consequences in decision-making and a greater tendency to prioritize long-term outcomes over short-term rewards, while lower scores suggest a weaker consideration of future consequences and a greater focus on immediate gratification and short-term benefits.
Change in Perceived Stress
时间窗: Baseline visit, Week 1, Week 3, Week 6, Week 12
Perceived stress refers to an individual's subjective assessment of the level of stress they experience in response to various life events or circumstances.10-item Perceived Stress Scale (PSS-10). The total score can range from 0 to 40, with higher scores indicating higher perceived stress levels and greater psychological distress, while lower scores indicate lower perceived stress levels and less psychological distress.
Change in Quality of Life (QoL)
时间窗: Baseline visit, Week 1, Week 3, Week 6, Week 12
QoL helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. QoL will be measured using the 15-item Glaucoma Quality of Life (GQL-15) survey. The total score can range from 15 to 75, with higher scores indicating a poorer quality of life and a greater impact of glaucoma on one's well-being, and lower scores indicating a better quality of life and less impact of glaucoma on one's well-being.
次要结局
未报告次要终点