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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I270||Primary pulmonary hypertension, |
|
Intervention / Comparator Agent
|
|
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: 1609. 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. |