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CTRI Number  CTRI/2022/06/043395 [Registered on: 21/06/2022] Trial Registered Prospectively
Last Modified On: 05/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Nature based Intervention (NBI) for wellbeing of healthcare trainees 
Scientific Title of Study   Development and feasibility testing of Nature based Intervention (NBI) program on the well-being of healthcare trainees 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adil Hakkim 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS) 
Address  Department of Psychiatric Social Work, MV. Govindaswamy Building, NIMHANS, Hosur Road, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  8281137876  
Fax    
Email  aadhiaddz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Adil Hakkim 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS) 
Address  Department of Psychiatric Social Work, MV. Govindaswamy Building, NIMHANS, Hosur Road, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  8281137876  
Fax    
Email  aadhiaddz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Adil Hakkim 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neurosciences (NIMHANS) 
Address  Department of Psychiatric Social Work, MV. Govindaswamy Building, NIMHANS, Hosur Road, Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  8281137876  
Fax    
Email  aadhiaddz@gmail.com  
 
Source of Monetary or Material Support  
Infrastructure support is provided by the National Institute of Mental Health and Neuro Sciences (NIMHANS). 
 
Primary Sponsor  
Name  Adil Hakkim PI  
Address  Department of Psychiatric Social Work, MV Govindaswamy Building,NIMHANS, Hosur Road, Bangalore 560029 
Type of Sponsor  Other [Self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
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 Aarti Jagannathan  National Institute of Mental Health And Neurosciences (NIMHANS)  National Institute of Mental Health and Neuro Sciences (NIMHANS), Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden) Bangalore – 560029 Karnataka, India
Bangalore
KARNATAKA 		 9448150690

jaganaarti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Metal Health and Neurosciences (NIMHANS)Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Healthcare Trainees 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nature Based Intervention (NBI)  1 Hour daily 6-10 weeks (After the development of program) 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Healthcare trainees enrolled in NIMHANS under the behavioral sciences and Neurosciences division.
2. Those who have completed a minimum of 3 months (at least 1 clinical posting) at NIMHANS.
3. Any Gender 
 
ExclusionCriteria 
Details  1. Healthcare trainees who refuse consent to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wellbeing  Day 0, Day 60, Day 180 
 
Secondary Outcome  
Outcome  TimePoints 
Mindfulness  Day 0, Day 60, Day 180 
Self Efficacy  Day 0, Day 60, Day 180 
Professional Quality of Life  Day 0, Day 60, Day 180 
Sleep Quality  Day 0, Day 60, Day 180 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 2 
Date of First Enrollment (India)   02/01/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
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 -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aadhiaddz@gmail.com].

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 01-01-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The proposed study aims to develop  and test the feasibility of the Nature-Based Intervention (NBI) program on the well-being of healthcare trainees. This study follows a mixed-method, open-label, single-group, pre-post quasi-experimental study design with one intervention group with assessments at baseline, post, and follow-up. The study would be conducted in two phases. The first phase, the development phase would include extensive literature review, expert interviews, and an online survey. The second phase, the feasibility phase would include pilot testing and the main intervention phase with the sample group. The sample of 16 healthcare trainees will be recruited for the study from the tertiary healthcare settings using purposive sampling. After obtaining informed consent, they would undergo the intervention of the NBI program for 6 to 10 weeks  within the healthcare campus. The assessments for the primary outcome variable (well-being) and secondary outcome variables (mindfulness, self-efficacy, sleep quality, and professional quality of life) would be carried out at baseline, post the NBI program and as follow up after three months. 
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