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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06144138

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this electronic feasibility clinical trial study is to evaluate the effects of breathing and meditation techniques on stress levels in patients with glaucoma.

The main questions it aims to answer are:

Does breathing and meditation decrease the level of stress in glaucoma patients?
Does breathing and meditation improve disease specific quality of life in glaucoma patients
Does breathing and meditation affect the importance that in glaucoma patients place on future consequences? Participants will participate in online session where they will be taught proper breathing and meditation technique to practice. They will also be completing online questionnaires following independent practice sessions over time.

Researchers will compare the breathing and meditation group to the usual care group to see if the outcomes are different.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Stress Quality of Life	Behavioral: Breathing Exercises followed by Meditation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

May 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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. 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 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.
No Intervention: Treatment as Usual 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.

Arm

Intervention/Treatment

Experimental: 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. 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

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.

No Intervention: Treatment as Usual

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.

Outcome Measures

Primary Outcome Measures

Change in Quality of Life (QoL) [Baseline visit, Week 1, Week 3, Week 6, Week 12]
QoL helps physician identify hidden morbidity in clinical care as well as improves patient-physician communications. QoL will be measured using the 15-item Glaucoma Quality of Life (GQL-15) survey. The total score can range from 15 to 75, with higher scores indicating a poorer quality of life and a greater impact of glaucoma on one's well-being, and lower scores indicating a better quality of life and less impact of glaucoma on one's well-being.
Change in Perceived Stress [Baseline visit, Week 1, Week 3, Week 6, Week 12]
Perceived stress refers to an individual's subjective assessment of the level of stress they experience in response to various life events or circumstances.10-item Perceived Stress Scale (PSS-10). The total score can range from 0 to 40, with higher scores indicating higher perceived stress levels and greater psychological distress, while lower scores indicate lower perceived stress levels and less psychological distress.
Change in consideration of future consequences [Baseline visit, Week 1, Week 3, Week 6, Week 12]
Consideration of Future Consequences scale (CFC-10). The total score can range from 10 to 50, with higher scores indicating a stronger consideration of future consequences in decision-making and a greater tendency to prioritize long-term outcomes over short-term rewards, while lower scores suggest a weaker consideration of future consequences and a greater focus on immediate gratification and short-term benefits.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with glaucoma. Being able to provide valid informed consent to participate in the research study.

Patients aged 40-65. 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.

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.