- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03345381
Impact of Breathing Exercises and Meditation on Quality of Life in Dry Eye Disease Patients: A Pilot Study
Impact of Breathing Exercises and Meditation on Health-Related Quality of Life in Dry Eye Disease Patients: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Prevalence of dry eye disease (DED) ranges from 3.5% to 33.7% and increase with age. Further, DED is associated with decreased productivity, absenteeism from work, depression, and has an adverse impact on patient's quality of life. Odds of a DED patient suffering from depression is 2.9 and anxiety is 2.8. Yoga - a practice to help improve health and well-being - has also been the subject of clinical studies globally. Two central aspects of yoga practice are physical postures and breathing exercises. These breathing exercises aim to focus the mind, facilitate relaxation and enhance wellness.
Evidence further suggests beneficial effects of a standardized collection of breathing techniques called Sudarshan Kriya Yoga (SKY) on individuals suffering from depression. SKY includes three-stage breathing with Victory breath (slow deep breathing that consists of 4 to 6 breaths per minute), Bellow's breath (forceful rapid deep breathing that consists of 20 to 30 breaths per minute), and a rhythmic breath technique. SKY followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation. ASTM utilizes a specific sound value mantra to draw attention inward and permit the mind to experience a restful but alert state of consciousness. It helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. ASTM may help with depression, anxiety, stress, and may enhance quality of life. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. Key goal of proposed research is to evaluate HRQOL, depression, anxiety of patients with DED in SKY followed by ASTM and usual care (UC) versus UC alone from baseline to 24 weeks.
Primary Hypothesis: The investigators hypothesize that in patients with dry eye disease in SKY + ASTM + UC may lead to significant improvement in HRQoL compared to UC alone from baseline to 24 weeks.
Secondary Hypotheses: The investigators hypothesize that in patients with DED 1) HRQoL is associated with regularly measured clinical variables 2) SKY + ASTM + UC leads to significant improvement in depression and anxiety symptoms at 24 weeks compared to UC alone.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Monali Malvankar
- Phone Number: 61288 5196858500
- Email: monali.malvankar@sjhc.london.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6G0H8
- St. Joseph's Hospital, Ivey Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- dry eye disease suspects or have mild to severe dry eye disease
- at least between 18 to 80 years of age
- deemed competent such as no language issues or communication barriers, no self-reported or physician diagnosed mental health disorder besides having depressive and anxiety symptoms
- have sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 30 minutes
- willing and able to attend 3 initial SKY and 4 initial ASTM training sessions
- willing to dedicate 20 minutes per day for SKY and 20 minutes twice per day to ASTM practice at their own home.
Exclusion Criteria:
- actively suicidal as per self-report (or score on CES-D) or on assessment by the physician
- they are currently participating in other similar studies
- currently practicing any type of formal meditation techniques regularly
- unable or unwilling to answer survey questions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SKY + ASTM + usual care
Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) plus usual care
|
Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation.
|
Active Comparator: Usual Care
Treatment as usual
|
Treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health Related Quality of Life (HRQoL)
Time Frame: Up to 24 weeks
|
Health Related Quality of LIfe (HRQoL) is an essential measure of quality of life related to health.
HRQoL will be measured using time trade-off (TTO) questionnaire.
HRQoL varies between 0 and 1 where the score of 1 represents perfect health and 0 represents death.
|
Up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Function Score
Time Frame: Up to 24 weeks
|
Visual related quality of life measured using National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25).
The most widely used instrument in vision-related functioning is the NEI VFQ-25.
It was designed specifically for a clinical setting and consists of 12 domains: general health, general vision, visual pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, colour vision and peripheral vision.
The shorter 25-item version questionnaire is widely used in different groups of patients and shown to be internally consistent, reproducible and responsive in glaucoma patients.
The NEI VFQ-25 scores have a closer relationship to clinical outcomes, in comparison to generic instruments.
The scores range from 0 to 100 where higher score represents better vision related quality of life.
|
Up to 24 weeks
|
Depression
Time Frame: Up to 24 weeks
|
Center for Epidemiologic Studies Depression Scale (CES-D) will be used to measure depression.
It is one of the most common validated tools used to measure depression in research to identify depressive symptoms.
Additionally, it is a brief standardized valid tool for assessing depressive symptoms.
Possible range of scores is zero to 60, with the higher scores indicating the presence of more depressive symptoms.
|
Up to 24 weeks
|
State and Trait Anxiety
Time Frame: Up to 24 weeks
|
State-Trait Anxiety Inventory (STAI)
|
Up to 24 weeks
|
Sleep Quality
Time Frame: Up to 24 weeks
|
Pittsburgh Sleep Quality Index (PSQI)
|
Up to 24 weeks
|
Community Integration
Time Frame: Up to 24 weeks
|
The community integration questionnaire (CIQ) was used to provide a quantitative indicator for the level of social support and ability to perform appropriate roles at home and within the community.
The CIQ contains 15-items and uses behavioural items of integration to achieve better reliability.
The total CIQ score ranges from 0 to 29, with a higher score representing a higher level of social support and complete community integration.
|
Up to 24 weeks
|
Canadian Dry Eye Assessment
Time Frame: Up to 24 weeks
|
Canadian Dry Eye Assessment
|
Up to 24 weeks
|
Dry Eye Assessment
Time Frame: Up to 24 weeks
|
Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire
|
Up to 24 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.
- Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
- Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8. doi: 10.1001/archophthalmol.2009.103.
- Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.
- Wan KH, Chen LJ, Young AL. Depression and anxiety in dry eye disease: a systematic review and meta-analysis. Eye (Lond). 2016 Dec;30(12):1558-1567. doi: 10.1038/eye.2016.186. Epub 2016 Aug 12.
- Elder C, Nidich S, Moriarty F, Nidich R. Effect of transcendental meditation on employee stress, depression, and burnout: a randomized controlled study. Perm J. 2014 Winter;18(1):19-23. doi: 10.7812/TPP/13-102.
- Burns JL, Lee RM, Brown LJ. The effect of meditation on self-reported measures of stress, anxiety, depression, and perfectionism in a college population. Journal of College Psychotherapy 25(2): 132-144, 2011.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110762
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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