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CTRI Number  CTRI/2025/10/095514 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Preventive
Screening
Other (Specify) [Shavas Health App]  
Study Design  Cluster Randomized Trial 
Public Title of Study   EFFECTIVENESS OF SHVAS HEALTH APP ON PHYSIOLOGICAL AND PSYCHOLOGICAL PARAMETERS OF PATIENTS WITH COPD  
Scientific Title of Study   A STUDY TO EVALUATE THE EFFECTIVENESS OF SHVAS HEALTH APP ON PHYSIOLOGICAL AND PSYCHOLOGICAL PARAMETERS OF PATIENTS WITH COPD AT SELECTED HOSPITALS OF HARYANA. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shakuntala 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar College of Nursing, Mullana, Ambala, (Haryana) 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) - 133207
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) - 133207
Ambala
HARYANA
133207
India 
Phone  7807267792  
Fax    
Email  shakuntala@mmumullana.org  
 
Details of Contact Person
Scientific Query  
Name  Dr. Vinay Kumari 
Designation  Vice Principal cum Professor 
Affiliation  Maharishi Markandeshwar College of Nursing, Mullana, Ambala, (Haryana) 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) - 133207
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) - 133207
Ambala
HARYANA
133207
India 
Phone  7807267792  
Fax    
Email  viceprincipalmmcn@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr. Vinay Kumari 
Designation  Vice Principal Cum Professor 
Affiliation  Maharishi Markandeshwar College of Nursing, Mullana, Ambala, (Haryana) 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) - 133207
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) - 133207
Ambala
HARYANA
133207
India 
Phone  7973596469  
Fax    
Email  viceprincipalmmcn@mmumullana.org  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Maharishi Markandeshwar College of Nursing 
Address  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) 
Type of Sponsor  Other [Nursing College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shakuntala  Ambala, Haryana  Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, (Haryana) - 133207
Ambala
HARYANA 		 07807267792

chauhanshakuntala4@gmail.com 
Shakuntala  Ambala, Haryana  Civil Hospital Ambala Cantt
Ambala
HARYANA 		 07807267792

chauhanshakuntala4@gmail.com 
Shakuntala  Ambala, Haryana  civil hospital Ambala city
Ambala
HARYANA 		 07807267792

chauhanshakuntala4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Shvas Health App (breathing exercises)  The Shvas Health App included the patient’s data such as age, height, city/district, address, cellphone number, and family cell phone number. The “Information and educational videos at a The glance” menu will be divided into sections based on the pulmonary disease: COPD. Each section will be disease-related information and breathing exercises. • Section I: Briefly explain the disease condition • Section II: Breathing exercises videos • Section III: Lifestyle management • Section IV: Medication compliance • Section V: Guided Imagery Music • Section VI: Medication reminders To ensure all patients will use the Shvas Health App, a messaging application group was created, consisting of all patients and the researcher. The patients or companions will be reminded by researchers to use the application every day, and they will be instructed to record or provide Take a screenshot, and then share the evidence with the messaging group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  The study included COPD patients who will be
1. 18 or above 18 years of age
2. willing to participate
3. able to understand Hindi or English.
4. available during the period of data collection.
5. capable of using a smart smartphone application 
 
ExclusionCriteria 
Details  The study excluded COPD patients who would be
1. Severe ill, COPD patients with any malignancy and severe cardiovascular disorder.
2. Not capable of using a smartphone application 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study will be the change in both physiological and psychological parameters among COPD patients using Shvas Health App. For the physiological domain, the main outcome will be the reduction in dyspnea assessed by MMRC dyspnea scale. For the Psychological domain, the primary outcome will be the improvement in anxiety, depression and stress.  6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Chronic Obstructive Pulmonary Disease (COPD) is a significant global health concern, affecting millions of individuals worldwide. According to the Global Burden of Disease Study, the incidence of COPD is approximately 251 million cases globally, with significant morbidity and mortality associated with the disease. The World Health Organization (WHO) estimates that COPD is the third leading cause of death globally, accounting for 3.23 million deaths in 2019.

In India, the burden of COPD is substantial, with an estimated prevalence of around 5.8% among adults aged 30 years and older. A study published in 2022 highlighted the increasing incidence rates, particularly in urban areas due to pollution and smoking. The Indian government has identified COPD as a major public health issue, particularly in the context of rising air pollution levels and changing lifestyles

 PROBLEM STATEMENT

“A study to evaluate the effectiveness of Shvas Health App on Physiological and Psychological parameters of patients with COPD at selected hospitals of Haryana.’’

 

OBJECTIVES

1.  1. To asses and compare the Physiological and Psychological parameters of patients with COPD before administration of Shvas Health App.

2.  2. To assess and compare the Physiological and Psychological parameters of patients with COPD after administration of Shvas Health App.  

  3. To determine relationship between Physiological and Psychological parameters of patients with COPD.

  4. To determine the association of Physiological and Psychological parameters with selected variables of patients with COPD.

5.      To determine the usability of Shvas Health App among COPD patients.

6.      To determine the level of satisfaction of Shvas Health App among COPD patients.

HYPOTHESES

The following hypotheses will be tested at 0.05 level of significance.

H1:  There will be a significant difference in mean post test Physiological parameters score among patients with COPD in experimental group & control group.

H1.1:  There will be a significant difference in mean post test dyspnea score among patients with COPD in experimental group & control group.

H1.2: There will be a significant difference in mean posttest fatigue score among patients with COPD in experimental group & control group.

H1.3:  There will be a significant difference in mean posttest sleep quality score among patients with COPD in experimental group & control group.

H1.4: There will be a significant difference in mean post test respiratory symptoms score among patients with COPD in experimental group & control group.

H1.5:  There will be a significant difference in mean post test FEV1 score among patients with COPD in experimental group & control group.

H1.6:  There will be a significant difference in mean post test FVC score among patients with COPD in experimental group & control group.

H2:  There will be a significant difference in mean post test Psychological parameters score among patients with COPD in experimental & control group.

H2.1:  There will be a significant difference in mean post test anxiety score among patients with COPD in experimental group & control group

H2.2:  There will be a significant difference in mean post test depression score among patients with COPD in experimental group & control group

H2.2:  There will be a significant difference in mean post test stress score among patients with COPD in experimental group & control group

H3: There will be a significant relationship between Physiological and Psychological parameters of patients with COPD in experimental group & control group.

H4: There will be a significant association of Physiological and Psychological parameters with selected variables of patients in experimental group & control group.


 
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