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

Primary Purpose

Glaucoma, Depression, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Breathing Exercises followed by Meditation
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring Health-related Quality of Life, Glaucoma, COVID-19, Breathing, Meditation

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion and Exclusion Criteria Inclusion Criteria 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. 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 ≥ 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.

Sites / Locations

  • St. Joseph's Hospital, Ivey Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breathing Exercises followed by Meditation

No Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
Change in Anxiety
Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale
Change in Sleep quality
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2023
Last Updated
October 16, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05960513
Brief Title
Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients
Official Title
Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients: An Electronic Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Depression, Anxiety, Quality of Life, Sleep Disorder
Keywords
Health-related Quality of Life, Glaucoma, COVID-19, Breathing, Meditation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathing Exercises followed by Meditation
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breathing Exercises followed by Meditation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in health-related quality of life (HRQoL)
Description
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
Time Frame
Baseline visit, Week 1, Week 3, Week 6, Week 12
Title
Change in Depression
Description
Depression is a feeling of severe despondency and dejection. Depression will be measured using the Center for Epidemiological Studies - Depression (CES-D) score.
Time Frame
Baseline visit, Week 1, Week 3, Week 6, Week 12
Title
Change in Anxiety
Description
Anxiety will be measured using Hospital Anxiety and Depression Scale - Anxiety (HADS-A) subscale
Time Frame
Baseline visit, Week 1, Week 3, Week 6, Week 12
Title
Change in Sleep quality
Description
Sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI) scores.
Time Frame
Baseline visit, Week 1, Week 3, Week 6, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion and Exclusion Criteria Inclusion Criteria 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. 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 ≥ 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monali Malvankar, PhD
Phone
5192815260
Ext
61288
Email
monali.malvankar@schulich.uwo.ca
Facility Information:
Facility Name
St. Joseph's Hospital, Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6G0H8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott McKinnon
Phone
519 685-8500
Ext
58250
Email
scott.mckinnon@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Cindy Hutnik, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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