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

Depression Clinical Trial

Official title:

Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients: An Electronic Pilot Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960513
• Other study ID #: 122096
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Monali Malvankar, PhD
• Phone: 5192815260
• Email: monali.malvankar[@]schulich.uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion and Exclusion Criteria Inclusion Criteria

1. Patients diagnosed with glaucoma.

2. Patients aged 40-65.

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. Independent access to a computer to participate in virtual 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Glaucoma
• Quality of Life
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Behavioral:
• Breathing Exercises followed by Meditation
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.

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital, Ivey Eye Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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