EFFECT OF YOGA THERAPY IN MODIFYING STRESS IN PATIENTS WITH PSORIASIS: A RANDOMIZED CONTROL TRIAL

Introduction:

Psoriasis is an immune-mediated disease that causes raised, red,scaly patches to appear on the skin. Stress appears to be an importantprecipitating factor in the development and exacerbation of psoriasis. Theproportion of psoriasis patients who believe stress affects their skincondition (i.e., "stress responders") is considerably high, rangingfrom 37% to 78%. Stress, weaken the immune system and increase vulnerability toinfection and other health-related problems. Stressmay worsen psoriasis severity and may even lengthen the time to diseaseclearance. Yoga is a mind-body practice that combines physical poses,controlled breathing, and meditation or relaxation. Several studies shows thatyoga helps reduce stress, lower blood pressure, normalize your heart rate andimprove quality of life. However, the effect of yoga therapy inmodifying stress in patients with psoriasis has not been reported so far. Tothe best of our knowledge, the present study may be the first of its kind to bereported in the literature.

 Aims and Objectives:

Aim: To study the effect of yoga as adjuvant therapy and compare withstandard medical management alone in modifying stress in patients withpsoriasis.

Objectives:

1.     To evaluate the effect ofadjuvant yoga therapy and compare with standard medical management alone on

a.      Anthropometric parameters(weight and Body Mass Index).

b.     Physiological parameters (bloodpressure and heart rate).

c.      Psychological parameters (PSS,DQOL).

d.     Biochemical parameter (Salivarycortisol).

2.     To evaluate clinical changes ofadjuvant yoga therapy through Psoriasis Area and Severity Index (PASI) scaleand compare with standard medical management alone.

Subjects and Methods:

The present study will be conducted among patients admitted in thedermatology ward of the Mahatma Gandhi Medical College and Research Institutewho have been clinically diagnosed with psoriasis. The patients will beprospectively interviewed and enrolled for the study after fulfilling theinclusion and exclusion criteria. Subjects will be informed about the study andtheir consent will be taken.

Using Sample Size Calculator Application, Sample size was calculatedwith confidence level of 95%, power 80%, effect size is 0.6, and ratio is 1,altogether minimum total sample size needed is 90. Adding 10% dropout, we getsample size of 100 for the present study.

Using Block randomization subjects (n=100) will be divided into twogroups. Group A - Bi weekly yoga therapy for 3 months with standard medicalmanagement (n=50). Group B – Controls - standard medical management (n=50) andby using zelen’s design subject group change will be done.

Work Plan:

·        100 patients of chronicpsoriasis (Illness for more than 3 months) on standard medical management willbe recruited after obtaining informed consent.

·        Randomization of subjects willbe done into

o  Group A of 50 subjects (yogatherapy for 3 months with standard medical management) and

o  Group B of 50 subjects(controls receiving only standard medical management).

·        Pre study evaluation of

o  Anthropometry: height, weight,BMI.

o  Physiological parameter: BP, HR

o  Psychological parameter: (PSS),(DQoL)

o  Biochemical parameters:Salivary Cortisol

o  Clinical Parameter: PsoriasisArea and Severity Index (PASI) scale.

·        Yoga Therapy as per the CYTERprotocol will be given to subjects in the experimental group. (Total duration:50 min)

·        Participants will be motivatedto practice at home and maintain a diary that will be used to evaluatecompliance and for correlation analysis if possible at the end of the study.

·        Post-test analyses of allparameters will be done again at end of 3-month study period to assess effectsof yoga therapy.

·        Data analyses will be done.

·        Changes in all parameters willbe correlated with compliance to Yoga Therapy will be assessed.

·        Preparation of final report forpublication.

·        After the study period, Yogatherapy will be offered to control subjects who are interested.

 Statistical Methods:

·        Student’s paired t test will beused for intra group comparisons for data passing normality testing andWilcoxon matched-pairs signed-ranks test for others.

·        Students unpaired t test willbe used for inter group comparison for data passing normality testing andManWhitney U test otherwise.

·        P value <0.05 will beconsidered as significant.