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

NCT ID: NCT05697094

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-30

Brief Summary

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).

Conditions

Glaucoma; Depression; Anxiety; Sleep Disorder; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Meditation to Remove Stress and Create A Proper System in Mind

Intervention Type: BEHAVIORAL

Meditation to Remove Stress and Create A Proper System in Mind is a guided meditation.

Usual Care

Participants will continue with their usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Beyond Mindfulness Meditation

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Monali Malvankar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, Canada

Countries

Canada

Central Contacts

Monali Malvankar, PhD

Role: CONTACT

monali.malvankar@schulich.uwo.ca

5196858500 ext. 61288

References

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.

Reference Type: BACKGROUND

PMID: 30036361 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18976496 (View on PubMed)

Other Identifiers

119431

Identifier Type: -

Identifier Source: org_study_id