Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients

NCT05960513 | Unknown DMC

• 1 other identifier: 122096
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Health-related Quality of Life; Glaucoma; COVID-19; Breathing; Meditation

Outcome Measures

Primary Outcomes (4)

• Change in health-related quality of life (HRQoL)

  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

  Baseline visit, Week 1, Week 3, Week 6, Week 12

• Change in Depression

  Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score.

  Baseline visit, Week 1, Week 3, Week 6, Week 12

• Change in Anxiety

  Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale

  Baseline visit, Week 1, Week 3, Week 6, Week 12

• Change in Sleep quality

  Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores.

  Baseline visit, Week 1, Week 3, Week 6, Week 12

Study Arms (2)

Breathing Exercises followed by Meditation

EXPERIMENTAL

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.

Behavioral: Breathing Exercises followed by Meditation

No Intervention

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.

Interventions

Breathing Exercises followed by Meditation BEHAVIORAL

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. Meditation is a guided meditation that helps to eliminate stress and establish an apposite system in the mind, therefore inducing physiological and mental relaxation whilst the eyes are shut. The proposed duration and frequency of the follow-up will be 60-minutes weekly for 11 weeks.

Breathing Exercises followed by Meditation

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients diagnosed with glaucoma.
• Patients aged 40-65.
• 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.
• 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.
• 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 ≥ 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 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.

Sponsors & Collaborators

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

Study Sites (1)

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, N6G0H8, Canada

Location

MeSH Terms

Conditions

Glaucoma; Depression; Anxiety Disorders; Sleep Wake Disorders; COVID-19; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes

Central Study Contacts

Monali Malvankar, PhD

CONTACT

5192815260; monali.malvankar@schulich.uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 25, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)