GlaucomaNCT06144138
Impact of Breathing Exercises and Meditation on Reducing Stress and Improving Quality of Life of Glaucoma Patients: An Electronic Pilot Feasibility Study
A study testing Breathing Exercises followed by Meditation in people with Glaucoma and Stress, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Glaucoma, Stress, Quality of Life
- What is being tested?
- Breathing Exercises followed by Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Hospital, Ivey Eye Institute
London, Ontario, N6G0H8
Scott McKinnon, 519519 685-8500 ext. 58250, scott.mckinnon@sjhc.london.on.ca
Cindy Hutnik, MD
About this study
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:
Read more
- 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.
- Conditions
- Glaucoma, Stress, Quality of Life
- Being tested
- Breathing Exercises followed by Meditation
- Keywords
- Glaucoma, Breathing, Meditation, Stress, Quality of life, Future consequences
- Medical subject headings
- Glaucoma, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Exercises followed by MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breathing Exercises followed by Meditation |
| Treatment as Usual | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life (QoL)
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.
Measured: Baseline visit, Week 1, Week 3, Week 6, Week 12
Change in Perceived Stress
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.
Measured: Baseline visit, Week 1, Week 3, Week 6, Week 12
Change in consideration of future consequences
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.
Measured: Baseline visit, Week 1, Week 3, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144138
- Sponsor's protocol ID
- 124123
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breathing Exercises and Meditation on Reducing Stress and Improving Quality of Life of Glaucoma Patients: An Electronic Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06144138
- Acronym / sponsor ID
- 124123
- Conditions
- Glaucoma, Stress, Quality of Life
- Keywords
- Glaucoma, Breathing, Meditation, Stress, Quality of life, Future consequences
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercises followed by Meditation | Experimental | Behavioral: Breathing Exercises followed by MeditationBreathing 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. |
| Treatment as Usual | 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing Exercises followed by MeditationBreathing 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. | Behavioural | Breathing Exercises followed by Meditation |
Primary outcome
Change in Quality of Life (QoL)
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises followed by Meditation in people with Glaucoma and Stress, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monali Malvankar, PhD (5192815260 ext. 61288, monali.malvankar@schulich.uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (QoL) (time frame: Baseline visit, Week 1, Week 3, Week 6, Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.