Impact of Meditation on Improving Quality of Life Among Glaucoma Patients: An Electronic Pilot Feasibility Study

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Quality of Life; Glaucoma; Sleep Disorder; Anxiety
• Intervention / Treatment: Behavioral: Meditation to Remove Stress and Create A Proper System in Mind

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monali Malvankar, PhD; Phone Number: 61288 5196858500; Email: monali.malvankar@schulich.uwo.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G0H8
      • St. Joseph's Hospital, Ivey Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Patients diagnosed with mild glaucoma.
2. Patients aged 65-75.
3. Being able to provide valid informed consent to participate in the research study.
4. Being able to read and understand English.
5. Having no significant self-reported or physician-diagnosed mental health disorder.
6. Able to independently access a computer to participate in virtual meditation sessions.
7. 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

1. Inability to provide valid informed consent.
2. Significant communication barriers or lack of English proficiency that prevents participants from completing the questionnaires.
3. Severe depression as confirmed by a CES-D ≥ 24.
4. 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).
5. Self-reported substance abuse or dependence within the past 3 months.
6. Having acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months.
7. Having irreversible vision loss that prevents one from completing the questionnaires.
8. Participation in a study involving similar techniques.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Meditation to Remove Stress and Create A Proper System in Mind; Meditation to Remove Stress and Create A Proper System in Mind is a guided meditation.; Other Names: Beyond Mindfulness Meditation
No Intervention: Usual Care; Participants will continue with their usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 12-item short form survey	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.	Week 1, week 3, week 6, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score. The CES-D provides scores from 0 to 60. Higher scores indicate worse outcome.	Week 1, week 3, week 6, week 12
Anxiety	Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale. The HADS-A provides scores from 0-21. Higher scores indicate worse outcome.	Week 1, week 3, week 6, week 12
Sleep quality	Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores. The PSQI provides scores from 0-21. Higher scores indicate worse outcome.	Week 1, week 3, week 6, week 12

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Publications and helpful links

General Publications

• Atreya CE, Kubo A, Borno HT, Rosenthal B, Campanella M, Rettger JP, Joseph G, Allen IE, Venook AP, Altschuler A, Dhruva A. Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. PLoS One. 2018 Jul 23;13(7):e0199423. doi: 10.1371/journal.pone.0199423. eCollection 2018.
• Yunesian M, Aslani A, Vash JH, Yazdi AB. Effects of Transcendental Meditation on mental health: a before-after study. Clin Pract Epidemiol Ment Health. 2008 Nov 1;4:25. doi: 10.1186/1745-0179-4-25.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Meditation; Glaucoma; Health-related quality of life
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Ocular Hypertension; Glaucoma; Sleep Wake Disorders
• Other Study ID Numbers: 119431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data (IPD) collected in this study will not be available to other researchers (e.g., outside the primary research group). Since the primary research group has the necessary expertise to analyze the data and do not need any outside help.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No