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CTRI Number  CTRI/2024/10/076041 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross-sectional Study 
Study Design  Other 
Public Title of Study   Exploration of sexual functioning in men with pulmonary hypertension  
Scientific Title of Study   Sexual functioning in men with pulmonary hypertension: a qualitative exploratory study  
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhruvi N Shah  
Designation  M.Phil Clinical Psychology Trainee 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8220084479  
Fax    
Email  dhruvi.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sebastian Padickaparambil 
Designation  Additional Professor 
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9945136060  
Fax    
Email  sebastian.p@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ms Anagha S Deshmukh  
Designation  Assistant Professor- Senior Scale  
Affiliation  Manipal College of Health Professions, Manipal Academy of Higher Education 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7259619947  
Fax    
Email  anagha.deshmukh@manipal.edu  
 
Source of Monetary or Material Support  
Department of Clinical psychology, Kasturba Hospital, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, India - 576104  
 
Primary Sponsor  
Name  Dhruvi N. Shah 
Address  Department of Clinical Psychology, Manipal College of Health Professions, Madhav Nagar, Manipal, Karnataka  
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 
Dhruvi N Shah   Kasturba Hospital   4th Floor, Department of Clinical Psychology, Kasturba Hospital, Tiger Circle, Madhav Nagar, Eshwar Nagar, Manipal, Udupi- 576104
Udupi
KARNATAKA 
8220084479

dhruvi.mchpmpl2023@learner.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  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 
Intervention  Nil   Nil  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1. Men diagnosed with pulmonary hypertension since at least one year post marriage.
2. Individuals who can speak English and Hindi.
 
 
ExclusionCriteria 
Details  1. Patients diagnosed with any psychiatric conditions or have undergone any psychiatric treatment in the past one year.
2. Patients who have suffered from leg or spine fracture in the past 6 months.
3. Patients who have had recent cardiac events in the past 6 months.
4. Recent hospitalization in the past 1 month.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The current study will aid in understanding the knowledge, belief, attitudes and experience of sexual functioning after the diagnosis of pulmonary hypertension  4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NIL  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/11/2024 
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="8"
Days="0" 
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  


Brief Summary 

Pulmonary hypertension (PH) is a cardiovascular condition that increases pressure in blood vessels between the heart and lungs, reducing oxygen levels and leading to avoidance of physical and sexual activities due to symptoms like shortness of breath and chest pain. Treatments involving pumps and catheters also create physical challenges to intimacy. Around 72% of patients report a decline in sexual activity, which affects quality of life. While research has explored sexual functioning of females suffering from Pulmonary Hypertension patients. It has been found that they have significant difficulties in sexual life including sexual dysfunction, fear of eliciting symptoms, doubt and shame related to sexual intercourse due to lack of knowledge, and facing negative body image concerns which interfere with healthy sexual functioning. Feelings of guilt associated with the impact of their disease on their relationship and reduced intimacy were also expressed. (Banerjee et al., 2018; Cipolletta et al., 2022)

 However, there is a lack of focus on men, especially in the Indian context where cultural views on sexuality play a significant role. This study aims to explore the sexual functioning of married men with Pulmonary Hypertension to develop interventions that improve sexual health and quality of life.

The study will run from November 2024 to May 2025. Married men aged 25-50, diagnosed with PH for at least a year post-marriage, will be interviewed using a semi-structured guide. Data will be analyzed using thematic analysis to inform healthcare professional training and future interventions.

 

 
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