| CTRI Number |
CTRI/2025/02/079891 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out how much parents know and what is their opinion about HPV vaccination for girls aged 9 to 14 years focusing on employees (parents of female children aged 9 to 14 years) in selected institutions of Udupi Taluk Karnataka. |
|
Scientific Title of Study
|
A cross sectional study to assess the knowledge and attitude on HPV vaccination among parents of female children aged between 9 to 14 years of selected institutions of Udupi Taluk Karnataka. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surekha |
| Designation |
P G student |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
community health nursing speciality
Manipal College of Nursing
MAHE
Manipal
Udupi Taluk
Udupi
KARNATAKA
576104
India |
| Phone |
9980768812 |
| Fax |
|
| Email |
samanth.surekha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ansuya |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Department of Community Health Nursing
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535894558 |
| Fax |
|
| Email |
ansuya.bengre@maniapal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Surekha |
| Designation |
P G student |
| Affiliation |
Manipal College of Nursing MAHE Manipal |
| Address |
Community Health Nursing speciality
Manipal College of Nursing
MAHE Manipal
Udupi Taluk
Udupi
KARNATAKA
576104
India |
| Phone |
9980768812 |
| Fax |
|
| Email |
samanth.surekha123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Surekha |
| Address |
Manipal College of Nursing
MAHE Manipal
Udupi taluk Karnataka state
India
576104 |
| 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 |
| Surekha |
Manipal Academy of Higher Education Manipal |
Kasturba Medical college conference room, Kasturba hospital nursing, teaching and non teaching employees, Manipal institute of technology Manipal lecture hall, Manipal college of nursing conference room, Dr. TMA Pai Hospital Udupi conference room
Udupi
KARNATAKA |
9980768812
samanth.surekha123@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical College and Kasturba HospitalInstitutional Ethics Committe-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Employees of Manipal Academy of Higher Education who meet the inclusion criteria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
The parents of female children between the ages of 9 to 14 years working at different institutions of Udupi Taluk Karnataka
Participants who can read and write English or Kannada
|
|
| ExclusionCriteria |
| Details |
Parents who don’t consent the participation in the study,
Parents whose children have received the HPV vaccine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The purpose of the study is to identify knowledge gaps, increase awareness, empowering decision-making regarding HPV vaccination among parents of female children aged between 9 and 14 years.
The findings of the research study will be utilized to empower parents regarding vaccinating their children and protecting them from life-threatening diseases such as carcinoma of the cervix caused by the HPV virus.
OBJECTIVES OF THE STUDY
• To assess the knowledge on HPV vaccination among parents of female children aged between 9 and 14 years using a knowledge questionnaire.
• To determine the attitude of parents of female children aged between 9 and 14 years towards HPV vaccination using a Likert rating scale.
• To find the association between knowledge of HPV vaccination and selected demographic variables.
|
4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="453"
Sample Size from India="453"
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)
|
14/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The data collection for the study will be done only after the approval of CTRI. The tentative data collection for the study is targeted from 2nd February 2025 to 9th March 2025 in the spend of one month. The participants will be recruited only after participants are consenting in the informed consent form. |