| 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
|
|
|
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
|
|
|
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.
|