Clinical trial NCT03345381: Impact of Breathing Exercises and Meditation on Quality of Life in Dry Eye Disease Patients: A Pilot Study
Official title: Impact of Breathing Exercises and Meditation on Health-Related Quality of Life in Dry Eye Disease Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Quality of Life
Dry Eye
Anxiety
Sleep
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: People staring at computer screens for long hours, blinking less frequently, or having long-term contact lens wear are prone to dry eye disease (DED). DED is a multifactorial disease accompanied by inflammation of the ocular surface. Further, DED may degrade vision and is associated with depression and have an adverse impact on patient's quality of life. Sudarshan Kriya Yoga (SKY) incorporates standardized collection of breathing techniques followed by Automatic Self Transcending Meditation (ASTM) may help reduce stress, depression, and anxiety, enhance quality of life in patients diagnosed with DED. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. The investigators plan to conduct a single-center pilot RCT. Patients with DED will be randomized to SKY followed by ASTM plus Usual care (UC) or UC alone to assess changes in health-related quality of life (HRQOL). HRQOL is a vital construct focusing on impact of health on quality of life. Along with HRQOL the investigators will measure changes in extent of depression and anxiety. Additionally, majority of current ophthalmic literature describes changes in clinical variables whilst lacking information on HRQOL. Thus, there is a high necessity to assess if there is an association between HRQOL and routinely measured clinical data. Through this study the investigators shall attempt to correlate HRQOL with clinical data.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Health Related Quality of Life (HRQoL)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Visual Function Score
timeFrame: Up to 24 weeks
measure: Depression
timeFrame: Up to 24 weeks
measure: State and Trait Anxiety
timeFrame: Up to 24 weeks
measure: Sleep Quality
timeFrame: Up to 24 weeks
measure: Community Integration
timeFrame: Up to 24 weeks
measure: Canadian Dry Eye Assessment
timeFrame: Up to 24 weeks
measure: Dry Eye Assessment
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital, Ivey Eye Institute
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Monali Malvankar
role: PRINCIPAL_INVESTIGATOR
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