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CTRI Number  CTRI/2024/10/074914 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Is the Ability of Young Unmarried Men to Express Feelings shaped by Their Emotion Regulation and Sense of Social Support? 
Scientific Title of Study   Emotion Regulation and Perceived Social Support as the predictors of Normative Male Alexithymia among Young Unmarried Men. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagarika UK 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9886511100  
Fax    
Email  sagarika.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sweta N Kulkarni  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9900038031  
Fax    
Email  sweta.kulkarni@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Priyesh C 
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka- 576104

Udupi
KARNATAKA
576104
India 
Phone  9538752702  
Fax    
Email  c.priyesh@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India 576104 
 
Primary Sponsor  
Name  Sagarika UK 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104 
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 Sweta Kulkarni  Manipal College of Health Professions, Manipal Academy of Higher Education  Room number 2 Clinical Psychology, Department of Clinical Psychology, Manipal Academy of Higher Education, Madhav Nagar, Udupi,Karnataka- 576104.
Udupi
KARNATAKA 		 9900038031

sweta.kulkarni@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  1.Individuals without any diagnosed mental health condition. 2.Individuals without any physical disability. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Male 
Details  1.Men who identify as cis-gendered heterosexual.
2.Men who are aged 20 to 30.
3.Men who are unmarried.
4.Men who are proficient in English language. 
 
ExclusionCriteria 
Details  1.Men diagnosed with any psychiatric illness and or are in psychopharmacological therapy/psychotherapy.
2.Men who have physical disabilities.
3.Men who are unequipped to use technology.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Emotion Regulation, Perceived Social Support and Normative Male Alexithymia scores will be the primary outcome attained at the end of the study. The first Independent Variable, Emotion Regulation, is measured by Emotion Regulation Questionnaire through its 2 factors: Cognitive Reappraisal (Range: 6-42) and Expressive Suppression (Range:6-28). Higher scores indicate greater use of the corresponding factor.
The second Independent Variable is Perceived Social Support measured by Multidimensional Scale of Perceived Social Support (MSPSS). Higher score indicates higher perceived social support (Range:12-84).
The Dependent Variable Normative Male Alexithymia is measured by Normative Male Alexithymia Scale-Brief Form (NMAS-BF). Higher scores reflect increased Normative Male Alexithymia (Range: 6-42). 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   22/10/2024 
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="0"
Days="9" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 prospective cross-sectional quantitative study aims to investigate Emotion Regulation and Perceived Social Support as predictors of Normative Male Alexithymia, among cis-gendered heterosexual unmarried men of age 20 to 30 who are proficient in English. Data will be collected by convenience sampling through forms circulated online to potential participants from KMC, Manipal and via social media. Data analysis employs Jamovi for statistical analysis, wherein the relationship among all the variables will be tested through Pearson/ Spearman correlation test and prediction of Normative Male Alexithymia will be done through Multiple Linear Regression. Necessary approvals will be obtained, ensuring confidentiality, offering mental health referrals, and responsible management of participant data will be ensured. 
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