FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091333 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to understand effects of sleep deprivation on mood and task switching of the medical residents and interns.  
Scientific Title of Study   Relationship Between Sleep Quality, Cognitive Flexibility and Emotional Regulation Amongst Medical Interns and Residents. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanisha Jaju 
Designation  Post graduate student 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9530234330  
Fax    
Email  tanisha.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Emarson VP  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  8847521527  
Fax    
Email  emarson.vp@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Emarson VP  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  8847521527  
Fax    
Email  emarson.vp@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Emarson VP  Manipal College of Health Professions  Department of Clinical Psychology Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, 576104
Udupi
KARNATAKA 		 8847521527

emarson.vp@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No medical/psychiatric condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Individuals currently working as medical intern or resident in any government or private hospital of India.
Individuals aged between 22-35 years.
Proficient in comprehending English.
 
 
ExclusionCriteria 
Details  Individuals with sleep wake disorders.
Individuals with mental illnesses.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To examine the role of sleep on cognitive flexibility and emotional regulation of medical residents and interns.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
Final Enrollment numbers achieved (Total)= "83"
Final Enrollment numbers achieved (India)="83" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) 31/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/01/2026 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   The title of the study is "Relationship Between Sleep Quality, Cognitive Flexibility And Emotional Regulation Amongst Medical Interns And Residents"

Aim of the study: To assess the relationship between sleep quality, cognitive flexibility and emotional regulation among medical students, and to find the mediating variable.

Objectives of the study: 
Primary objectives: 
To investigate the relationship between Sleep Quality, Emotional Regulation and Cognitive Flexibility amongst Medical Students.
To analyse the mediating role of the emotional regulation between sleep quality and cognitive flexibility.
To analyse the mediating role of the cognitive flexibility between sleep quality and emotional regulation, and to ascertain the model of best fit.

The study followed the approval from Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, the Institutional Research Committee (IRC), and the Institutional Ethics Committee (IEC)for review and clearance. Alongside receiving the ethical approval, registration under Clinical Trials Registry, India will be completed.

The information form consisting of the objectives of the research study and eligibility criteria to participate in the study will be circulated. On receiving the consent, the Demographic Details proforma, Pittsburgh Sleep Quality Index (PSQI), and Emotion Regulation Questionnaire would be administered, followed by task switch test. Data would be collected offline and will be extracted in a tabulated format. The data will be parsed to exclude responses which do not fulfill the inclusion criteria or contain missing data. Data will be analyzed using suitable statistical techniques. Data would be collected through voluntary participation. Data collected would be securely stored and analyzed to maintain confidentiality. Standardized psychological scales would be used to ensure data reliability and accuracy.

 
Close