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CTRI Number  CTRI/2024/11/077165 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   To study the impact of self-affirmation techniques on school teachers work-related stress and lifestyle 
Scientific Title of Study   Effectiveness of Self-Affirmation Technique on Work Stress and Lifestyle Among School Teachers 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavitha B 
Designation  Professor 
Affiliation  Aswini college of Nursing Thrissur 751 
Address  Department of Mental Health Nursing, Aswini College of Nursing, Nadathara, Minor road Thrissur-680751 Kerala India

Thrissur
KERALA
680751
India 
Phone  09645133906  
Fax    
Email  kavitha.21phdn101@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Jacintha Veigas 
Designation  Professor & Clinical Coordinator 
Affiliation  Nitte Usha Institute of Nursing sciences, Nitte Deemed to be University 
Address  Community Health Nursing Department Nitte Usha Institute of Nursing sciences Nitte Deemed to be University Mangalore-575018 Karnataka India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845230445  
Fax    
Email  jacintha@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr Jacintha Veigas 
Designation  Professor & Clinical Coordinator 
Affiliation  Nitte Usha Institute of Nursing Nitte Deemed to be University 
Address  Community Health Nursing Department Nitte Usha Institute of Nursing sciences Nitte Deemed to be University Mangalore-575018 karnataka India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845230445  
Fax    
Email  jacintha@nitte.edu.in  
 
Source of Monetary or Material Support  
Kavitha. B Department of Mental Health Nursing, Aswini College of Nursing, Nadathara, Minor road Thrissur-680751 Kerala India  
 
Primary Sponsor  
Name  KavithaB 
Address  Department of Mental Health Nursing, Aswini College of Nursing, Nadathara, Minor road Thrissur-680751 Kerala India 
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 
DrJacintha Veigas  Aswini college of nursing  Department of Psychiatric Nursing, Aswini college of nursing, Nadathara P.O thrissur -680751 kerala
Thrissur
KERALA 		 09645133906

kavitha.21phdn101@student.nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
central ethics committe Nitte DU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  higher secondary school teachers will be recruited for the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Self- Affirmation technique  includes following steps Conditioning: Self-introduction of the teachers and create rapport with them Induction: Relax the participant by self-hypnosis through the progressive muscle relaxation Autosuggestion: Affirmations for Emotional wellness, social wellness, Physical wellness, Intellectual and spiritual along with Ego strengthening script Termination of trance The technique will be practiced twice a day (afternoon and evening) for 21 days.  
 
Inclusion Criteria  
Age From  23.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Teachers who are taking classes in Higher secondary school
2. Teachers who are willing to participate in the study
 
 
ExclusionCriteria 
Details  1. The teachers have any significant medical or surgical ailments.
2. Teachers who are on Psychiatric treatment 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
the primary paramaters are the work stress and Lifestyle of the higher secondary school teachers will be assessed before and after the implementation of self- affirmation technique  at baseline, immediately, 2nd weeks, 6th weeks after
interventions 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the relationship between work stress score, Lifestyle score, and motivational score among the experimental group
 		 before starting the intervention and immediately after the intervention 
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   02/01/2025 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included kavitha.21phdn101@student.nitte.edu.in).

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 19-10-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The study is a Quantitative Research Approach and has employed Pre-test and Post-test Control Group time series Design. Initially assess the Pre-test level of work Stress & Lifestyle by using the Teachers Stress Inventory, and Lifestyle Questionnaire through the Google form. Then randomize the school (where higher secondary school teachers with moderate stress are present) into Experimental and control groups. Teach Self- Affirmative technique, to the experimental group and ensure competence using a self-developed checklist. Assess their motivation level by using the Intrinsic Motivation Inventory (IMI) and provide a motivational speech through structured teaching if required. Ensure regular practice of the Self-Affirmation technique twice a day afternoon and evening for 21 days by the Teachers. During the afternoon, the researcher will monitor the procedure, and in the evening through a video call. The steps will be taught to the teachers individually and their practice efficiency will be verified. later assess the Post-test level of Work Stress, and Lifestyle using the teachers’ stress inventory and lifestyle questionnaire immediately after the intervention and on the 2nd and 6th week after intervention also in person by the researcher. the primary outcome is to reduce the workstress and enhance the lifestyle of higher secondary school teachers and the secondary outcome is to find out the relationship between work stress, lifestyle, and motivational score of the experimental group

 
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