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CTRI Number  CTRI/2023/05/052596 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 11/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the impact of sexual distress, body image and self esteem on overall quality of life in women diagnosed with pulmonary hypertension  
Scientific Title of Study   Role of sexual distress, body image, and self esteem on quality of life among women with pulmonary hypertension  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sebastian P 
Designation  Head of The department, Associate Professor 
Affiliation  Manipal University  
Address  Department of clinical psychology, Manipal college of health professions,Manipal, Udupi, karnataka

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  Sebastian.p@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Akshita Kaushik  
Designation  M.Phil clinical psychology trainee 
Affiliation  Manipal University  
Address  Department of clinical psychology, Manipal college of health professions,Manipal, Udupi, karnataka

Udupi
KARNATAKA
576104
India 
Phone  8860349667  
Fax    
Email  Akshita.mcoahsma1@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Akshita Kaushik  
Designation  M.Phil clinical psychology trainee 
Affiliation  Manipal University  
Address  Department of clinical psychology, Manipal college of health professions,Manipal, Udupi, karnataka

Udupi
KARNATAKA
576104
India 
Phone  8860349667  
Fax    
Email  Akshita.mcoahsma1@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Kasturba medical college, Manipal 
 
Primary Sponsor  
Name  Akshita Kaushik  
Address  Department of clinical psychology, Manipal college of health professions  
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 
Akshita Kaushik   Kasturba Hospital  Department of cardiology, Kasturba medical college, Kasturba hospital, Manipal, Udupi, karnataka
Udupi
KARNATAKA 
8860349667

Akshita.mcoahsma1@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical college, Kasturba hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I270||Primary pulmonary hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Group 1 to 5 of women diagnosed with primary pulmonary hypertension
6 months after the diagnosis of pulmonary hypertension
Participants who can read English or Kannada 
 
ExclusionCriteria 
Details  History of any psychiatric disorders in the past 6 months
Patient admitted with acute right heart failure 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To investigate the role sexual distress, body image and self esteem on Quality of life among in with Pulmonary Hypertension  one time point 
 
Secondary Outcome  
Outcome  TimePoints 
1. To predict the role of sexual distress on quality of life among women with pulmonary hypertension
2. To predict the role of body image on quality of life among women with pulmonary hypertension
3. To predict the role of self esteem on quality of life among women with pulmonary hypertension 
one time point 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   15/05/2023 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Primary Objective

1. To investigate the role sexual distress, body image and self esteem on Quality of life among in with Pulmonary Hypertension

Sample size: 160

9. Detailed description of procedure / processes : With all permissions, translation of scales to vernacular language of Karnataka (Kannada) would begin. The translation would be carried out by the subject expert in the research team. Post this, the scales would be back translated from Kannada to English to ensure accuracy and resemblance to the original scale. The final version would be reviewed by the research team, involving the subject expert and expert from optometry (guide and co-guide respectively). The participants will be recruited from the cardiology department at Kasturba Medical College. The doctors and staff will be educated about the inclusion and exclusion criteria  of the study, so that they can administer the questionnaires when the patients come for a follow up,  The patients will be informed about the study, informed consent will be obtained from the patients, Information about demographic data and clinical details will be collected from the screened participants, The questionnaires FSDS-R, ASEX, EmPHasis, RSES and, BIS will be administered on the participants. Data collection would end in May 2023. This would be followed by data analysis and writing of thesis which is to be submitted in July 2023. 

 
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