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CTRI Number  CTRI/2023/12/060879 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 26/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   The impact of multimodal training program that includes training of life skills and yoga training on improving resilience, quality of sleep and coping with stress among nursing officers working in multispecialty hospitals of Bagalkot. 
Scientific Title of Study   Effectiveness of multimodal training program on quality of sleep, stress and resilience among Nursing officers working in tertiary care hospitals of Bagalkot. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Utalbasha N. Dhandargi 
Designation  Professor and HOD, Department o Community health nursing  
Affiliation  BVVS Sajjalashree Institute of Nursing sciences, Bagalkot, Karnataka 
Address  Community Health Nursing department, BVVS Sajjalashree Institute of Nursing sciences, SNMC campus, near HSK hospital, navanagar, Bagalkot. 587102

Bagalkot
KARNATAKA
587103
India 
Phone  9740750599  
Fax    
Email  undhandargi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Utalbasha N. Dhandargi 
Designation  Professor and HOD, Department of community health nursing 
Affiliation  BVVS Sajjalashree Institute of Nursing sciences, Bagalkot, Karnataka 
Address  Community Health Nursing department, BVVS Sajjalashree Institute of Nursing sciences, SNMC campus, near HSK hospital, navanagar, Bagalkot. 587102

Bagalkot
KARNATAKA
587103
India 
Phone  9740750599  
Fax    
Email  undhandargi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Utalbasha N.Dhandargi 
Designation  Professor and HOD, Department of Community health nursing 
Affiliation  BVVS Sajjalashree Institute of Nursing sciences, Bagalkot, Karnataka 
Address  Community Health Nursing department, BVVS Sajjalashree Institute of Nursing sciences, SNMC campus, near HSK hospital, navanagar, Bagalkot. 587102

Bagalkot
KARNATAKA
587103
India 
Phone  9740750599  
Fax    
Email  undhandargi@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India. 
 
Primary Sponsor  
Name  Utalbasha N Dhandargi 
Address  Professor and HOD Department of Community health nursing BVVS Sajjalashree Institute of Nursing Sciences SNMC campus navanagar Bagalkot Karnataka 587102 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh Sajjan  HSK Hospital and research centre Bagalkot  Seminar Hall, HSK, hospital and Research centre, SNMC campus, navanagar, Bagalkot, Karnataka 587102
Bagalkot
KARNATAKA 		 8548984436

santoshsajjan83@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIONS Institutional Ethical Committee on Human subjects research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PREVENTION OF INADEQUATE SLEEP HYGIENE AND ACUTE STRESS REACTION 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multimodal modal training program  The intervention is implemented for 30 hours divided into 6 dyas, that includes: training of specific Yogasanas as follows, Veera bhadrasana, Balasana, Supta baddha konasana, Viparita karani, Savasana, Pranayama and training of ten life skills with task oriented activities among nursing officers. 
Comparator Agent  No Treatment  No treatment 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1. Working as nursing officer in tertiary care hospital 2. Regularly posted for night shift duty 3.Give formal consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Nursing officers who are presently working on night shift duty 2. Expected to be on leave at the time of intervention. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Quality of sleep  3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Level of stress & Resilience  1 month 2 months & 3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   06/01/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
This study is a non randomized open label trail, with an aim to determine the effect of multimodal training program for 6 days among Nursing officers working in tertiary care hospitals. The primary outcome is quality of sleep which is measured before and after 3 months of Intervention and secondary outcomes are level of stress and resilience which will be measured before and 1 month, 2 month and 3 months of intervention. 
 
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