Impact of Breathing Exercises and Meditation on Improving Quality of Life in 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
- 50
- 试验地点
- 1
- 主要终点
- Change in health-related quality of life (HRQoL)
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, often due to increased intraocular pressure. Glaucoma is currently the leading cause of irreversible blindness worldwide.1 In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe glaucoma-induced visual impairment and blindness, respectively.1 However, these figures are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression.2 The relaxation response evoked by mind-body interventions, such as breathing exercises and meditation, is known to reduce stress and improve quality of life (QOL). In a recent study, mindfulness-based meditation was found to reduce intraocular pressure and improve QOL in patients with glaucoma.3 A feasibility study will be conducted using a mixed-method design to assess the feasibility of the online delivery of an intervention titled Breathing Exercises followed by Meditation for potentially enhancing the QOL and mental health of glaucoma patients. Upon recruitment, participants will undergo blocked randomization to either the intervention arm or usual care arm, stratified by sex. Participants in each arm will complete online questionnaires at baseline and after 12 weeks to collect data on health-related quality of life (HRQOL), depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI). Our study can help to assess the feasibility of conducting a pilot study on breathing exercises followed by meditation to assess its effects in a sample of patients with glaucoma.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion and
排除标准
- •Inclusion Criteria
- •Patients diagnosed with glaucoma.
- •Patients aged 40-
- •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.
- •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.
- •Exclusion Criteria
- •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
Breathing Exercises followed by Meditation
Breathing exercises and Meditation taught by Prasanna Wellness, a non-profit organization, helps dissolve stress and create a proper system in the mind. These breathing exercises include slow deep breaths and rapid breaths and are followed by meditation. Participants will receive three weekly online instructions (90 minutes each) by trained instructors in addition to standard care. Weekly 60 minutes follow-ups will include 10 minutes of breathing exercises followed by 33 minutes of guided meditation practice, and then focus on participants' experiences with breathing exercise followed by meditation during the week, additional observations, and a review of relevant knowledge to support their home practice.
干预措施: Breathing Exercises followed by Meditation (Behavioral)
No Intervention
The usual standard of care for patients with glaucoma includes starting them on first line of drugs. Participants will be initiated and maintained on appropriate dosages of such medications as part of standard of care. The usual standard of care also includes an ophthalmic examination measuring best-corrected Snellen VA and pinhole acuities and a follow-up visit once a year.
结局指标
主要结局
Change in health-related quality of life (HRQoL)
时间窗: Baseline visit, Week 1, Week 3, Week 6, Week 12
HRQoL is an essential measure of quality of life related to health; it helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. HRQoL will be measured using time trade-off questionnaire
Change in Anxiety
时间窗: Baseline visit, Week 1, Week 3, Week 6, Week 12
Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale
Change in Depression
时间窗: Baseline visit, Week 1, Week 3, Week 6, Week 12
Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score.
Change in Sleep quality
时间窗: Baseline visit, Week 1, Week 3, Week 6, Week 12
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores.
次要结局
未报告次要终点
研究者
Monali Malvankar
Assistant Professor
Lawson Health Research Institute