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CTRI Number  CTRI/2022/01/039099 [Registered on: 03/01/2022] Trial Registered Prospectively
Last Modified On: 11/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness of Workplace-Adapted Mindfulness-Based Programme for Life Insurance Agents 
Scientific Title of Study   Effectiveness of Workplace Based Mindfulness Programme in Life Insurance Agents-A Randomized Control Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tantri Keerthi Dinesh 
Designation  Research Scholar 
Affiliation  Department of Commerce,Manipal Academy of Higher Education 
Address  Old Tapmi Building Post Graduate and Research Centre Near Police station Manipal Academy of Higher Education Manipal
Old Tapmi Building Post Graduate and Research Centre Near Police station Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India 
Phone  9845845524  
Fax    
Email  tantri.dinesh@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Shwetha TS 
Designation  Assistant Professor 
Affiliation  Department of Clinical Psychology,Manipal Academy of Higher Education 
Address  Department of Clinical Psychology Manipal College of Health Profession Manipal Academy of Higher Education
Department of Clinical Psychology Manipal College of Health Profession Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  9880993080  
Fax    
Email  shwetha.ts@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ankitha Shetty 
Designation  Assistant Professor 
Affiliation  Department of Commerce,Manipal Academy of Higher Education 
Address  9th Block Near MIT grounds Department of Commerce Manipal Academy of Higher Education
9th Block Near MIT grounds Department of Commerce Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India 
Phone  8310797622  
Fax    
Email  ankitha.shetty@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education Manipal 
Address  Manipal Academy of Higher Education Manipal 576104 
Type of Sponsor  Other [Ph.D scholarship from institution] 
 
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 
Shwetha TS  Udupi  9th Block, Department of Commerce, Near MIT Grounds Eshwar Nagar, Manipal, Karnataka 567104
Udupi
KARNATAKA 
9880993080

shwetha.ts@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Life Insurance Agents in Insurance companies (agents with healthy conditions and those who are not under any medication) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  High Dose and Low dose comparison of mindfulness to life insurance agents  Prior permission will be taken form concerned authority of Insurance development officers where the researcher will visit the respondents on prior set date and time. In-depth interview will be conducted, recorded and transcribed with the consent of the participants. 6 weekly (2.5 hrs. per week) Intervention on Mindfulness will be conducted with the Randomized control trial design. Pre-test and posttest along with a 3 month follow up will be facilitated with the FFMQ questionnaire. For Phase I: Participants will be contacted through the list provided by Insurance development officers from the 6 different Life Insurance companies in Udupi District on the basis of their performances. The In-depth Interview will be conducted online and the data will be transcribed. For the Phase II : Selection of participants will be done by Insurance Development Officer on the basis of their performances, who will be later randomized for the study under a two armed randomized control trial using Random Number Generator (Random Researcher Tool). The interventions will be done in group .The randomized control trial will commence in Week 1 with pre-screening and later in Week 2 they will randomized to High Dose and Low dose Workplace Adapted Mindfulness-Based programming week 3 pre-test of FFMQ, a week before intervention will be given to the groups. In Week 4 after randomization the interventions will be conducted for experimental group and no additional instruction for comparison group will be given. In week 10 post-intervention questionnaire will be repeated similarly. A follow up of three months will be facilitated with the same questionnaire for comparing the results and finding the effectiveness. It will be an online survey. comparators will be High dose and low dose mindfulness  
Intervention  Workplace-Adapted Mindfulness-Based Programme for Life Insurance Agents   The randomized control trial will commence in Week 1 with pre-screening and later in Week 2 they will randomized to High Dose and Low dose Workplace Adapted Mindfulness-Based programming week 3 pre-test of FFMQ, a week before intervention will be given to the groups. In Week 4 after randomization the interventions will be conducted for experimental group and no additional instruction for comparison group will be given. In week 10 post-intervention questionnaire will be repeated similarly. A follow up of three months will be facilitated with the same questionnaire for comparing the results and finding the effectiveness. It will be an online survey.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Agents of first 6 Life Insurance companies ranking according to persistency level in Udupi District. Life Insurance agents who are on role will be included who are comfortable in speaking and understanding English. 
 
ExclusionCriteria 
Details  Life Insurance agents who are already practicing mindfulness and pregnant women.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome of intervention will be assessed on the scale for mindfulness with Five Facet Mindfulness Questionnaire. Variables will reflect with the stress factors which will be dependent on Mindfulness, Stress factors like target pressure, deadlines and workload being the job demands which are dependent on the Mindfulness interventions being independent variables. The scale will predict about the decrease in stress or no effect (as results determine) after interventions are incorporated.  6 weekly (2.5 hrs. per week) Intervention on Mindfulness will be conducted with the Randomized control trial design. Pre-test and posttest along with a 3 month follow up will be facilitated with the FFMQ questionnaire. 
 
Secondary Outcome  
Outcome  TimePoints 
Mindful selling of insurance products to the right customer after interventions by the life insurance agents  post test after 6weeks interventions and a 3 month follow up 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="450" 
Final Enrollment numbers achieved (Total)= "411"
Final Enrollment numbers achieved (India)="411" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/01/2022 
Date of Study Completion (India) 22/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

 Keeping in mind the various factors related to stress in Salesforce of a Life Insurance Sector, a proper model can be incorporated to bring out a “Mindful Selling Philosophy”. Mindfulness is an emergent construct where its implications are still at its early footsteps in human occupation. Little is known about how mindfulness is being applied and what are its possibilities in the disciplines of occupation. Workplace stress management trainings are found to be implemented at a slow pace, which typically focus on relaxation techniques and cognitive behavioural in turn reducing employee distress. Researchers have focused on investigating the benefits of mindfulness in the domains of nursing, medication and psychology and have very rarely examined them in the organizational and other professional context. Insurance agents stress factor has been overlooked when compared to stress factors of other private sectors like hospitals, logistics and banking. Mindfulness at workplace has underpinned cross sectional studies at maximum. Longitudinal studies are suggested for better results.

Individual Outcome: Acting with awareness, monitoring their thoughts and experiences, and accepting the stressful situations will enhance the coping skills and thereby pave the way for Mindful selling.

Industrial Outcome: This study sets a benchmark for Psychometric outcome where Insurance companies can assess the sense of mindfulness with the help of self-reports which would help in screening the applicants at the initial stage of recruitment as high mindful candidates and low mindful candidates based on which selection process can be made reliable and valid.

Societal implication: This study will showcase the Research Copyright enduring a social impact with this novel approach of introducing Mindfulness intervention and psychometric test in Life insurance Companies of India and psychometric generator showing the range of scores they have earned after filling the Mindfulness questionnaire.

 
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