Impact of Meditation on Reducing Stress in Glaucoma Patients During COVID-19 Pandemic

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05697094

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Visually impaired seniors are susceptible to having lower Quality of Life (QOL)1-4. The current situation-specific stressors including the fear of contracting COVID-19, prolonged periods of self-isolation, reduced mobility, greater dependence on caregivers or family members, reduced or no social interactions, inability to visit clinics for non-emergency treatments and surgeries, and financial uncertainty may further deteriorate the QOL of seniors with eye diseases. In this study, patients with moderate glaucoma aged 65 and above will be randomized to Art of Meditation (AOM) plus Treatment as usual (TAU) or TAU alone to assess the changes in Health-related quality of life (HRQoL). Patients in the AOM group will be taught a meditation technique by trained instructors while the patients in the TAU group continue to receive standard of care. It is hypothesized that it's feasible to assess the effects of AOM in a sample of glaucoma patients during COVID-19 pandemic, and that glaucoma patients will experience enhanced QOL, reduced depression and anxiety, and improved sleep quality by participating in the AOM intervention.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Depression Anxiety Sleep Disorder Quality of Life	Behavioral: Art of Meditation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Impact of Meditation on Reducing Stress in Glaucoma Patients During COVID-19 Pandemic: An Electronic Pilot Feasibility Study

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Art of Meditation Art of Meditation (AOM) is a type of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness. Participants will receive three weekly online instructions (90 minutes each) by trained instructors in addition to standard care.	Behavioral: Art of Meditation Art of Meditation (AOM) is a type of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness. Other Names: Sahaj Samadhi Meditation Automatic Self-Transcending Meditation
No Intervention: Treatment as Usual 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.

Arm

Intervention/Treatment

Active Comparator: Art of Meditation

Art of Meditation (AOM) is a type of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness. Participants will receive three weekly online instructions (90 minutes each) by trained instructors in addition to standard care.

Behavioral: Art of Meditation

Other Names:

Sahaj Samadhi Meditation

Automatic Self-Transcending Meditation

No Intervention: Treatment as Usual

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.

Outcome Measures

Primary Outcome Measures

Change in health-related quality of life (HRQoL) [Week 0, week 4]
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.

Secondary Outcome Measures

Visual Function Score [Week 0, week 4]
Visual Function score will be measured using Visual Function Questionnaire (VFQ-25).
Depression [Week 0, week 4]
Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score.
Anxiety [Week 0, week 4]
Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale
Sleep quality [Week 0, week 4]
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients diagnosed with glaucoma by an experienced ophthalmologist.
Patients aged 65 and above.
Be 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.
Access to technology to participate in virtual AOM sessions.
Able to sit comfortably for 90 minutes without any major pain or discomfort, hear well enough to follow verbal instructions when the eyes are closed, and be in good general physical health.

Exclusion Criteria

Inability to provide a 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 ≥ 24.
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 an 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.