Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The 12-item short form survey
研究概览
简要总结
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage due to increased intraocular pressure. Currently, it is the leading cause of irreversible blindness worldwide1. In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe visual impairment and blindness respectively induced by glaucoma1. However, these predictions are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression2.
There is a convincing body of evidence suggesting that there is a linear relationship between visual impairment and decreased quality of life (QOL) among glaucoma patients3. Furthermore, evidence from The National Health and Aging Trends Study suggests that this relationship may be bidirectional where older adults with visual impairment are more likely to suffer from mental illness and older adults with mental illness are more likely to suffer from visual impairment4. Mindfulness-based meditation is a promising non-pharmacological treatment that has been shown to reduce intraocular pressure and improve QOL in patients with glaucoma5.
A feasibility study will be conducted using a mixed-method design to assess the feasibility of delivering a meditation intervention online to enhance the QOL and mental health of glaucoma patients. Participants will be recruited and randomized in blocks of 10 and will undergo 1:1 randomization to the intervention arm or usual care arm. The purpose of this block randomization technique is to minimize the wait time between patient recruitment and study initiation. Participants in each arm will complete online questionnaires at patient recruitment, weeks 1, 3, 6, and 12 to measure self-reported health, depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI).
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with mild glaucoma.
- •Patients aged 65-
- •Being able to provide valid informed consent to participate in the research study.
- •Being able to read and understand English.
- •Having no significant self-reported or physician-diagnosed mental health disorder.
- •Able to independently access a computer to participate in virtual meditation 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.
- •Severe depression as confirmed by a CES-D ≥
- •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.
研究组 & 干预措施
Meditation to Remove Stress and Create A Proper System in Mind
The study intervention will be administered to participants randomized to the intervention arm. The meditation intervention will be delivered virtually via the hospital-approved Microsoft Teams platform. Participants will be taught an evidence-based meditation technique which includes two online sessions (60 minutes/day) with a trained, experienced, and certified teacher of Prasanna Wellness, a non-profit service organization. Participants will learn how to respond to experiences that arise in meditation, will discuss what enhances or detracts from effective meditation, and review methods for meditating at home. The participants in the intervention arm will complete 60-minute follow-up sessions with the Prasanna Wellness staff which will include 33 minutes of guided meditation practice, and then a discussion of participants' experiences with meditation during the week, additional observations, and a review of relevant knowledge to support their home practice.
干预措施: Meditation to Remove Stress and Create A Proper System in Mind (Behavioral)
Usual Care
Participants will continue with their usual care.
结局指标
主要结局
The 12-item short form survey
时间窗: Week 1, week 3, week 6, week 12
The 12-Item Short Form Survey (SF-12) is a questionnaire that measures self-reported health. Scores are calculated by converting the sum of responses to a scale from 0 to 100 where a higher score indicates superior health. In addition, results can be summarised using the physical component summary (PCS) score and the mental component summary (MCS) score.
次要结局
- Sleep quality(Week 1, week 3, week 6, week 12)
- Depression(Week 1, week 3, week 6, week 12)
- Anxiety(Week 1, week 3, week 6, week 12)
研究者
Monali Malvankar
Assistant Professor
Lawson Health Research Institute