| CTRI Number |
CTRI/2025/09/093966 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sensitization programme to improve knowledge and attitude about diseases caused by human papilloma virus |
|
Scientific Title of Study
|
Effect of sensitization programme on knowledge and attitude against diseases caused by human papilloma virus among nursing students of Puducherry-one group pre- and post-test 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 |
Pratyasa Banerjee |
| Designation |
M.sc nusing student |
| Affiliation |
Jawaharlal Institute Of Post Graduate Medical Education & Research |
| Address |
College of nursing, OBG Department, Jawaharlal Institute of Post Graduate Medical Education & Research, Dhanvantri Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8768301652 |
| Fax |
|
| Email |
banerjeepratyasa99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sivasankari k |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute Of Post Graduate Medical Education & Research |
| Address |
College of nursing, OBG Department, Jawaharlal Institute of Post Graduate Medical Education & Research, Dhanvantri Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9994902057 |
| Fax |
|
| Email |
sivasankari.k.09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sivasankari k |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute Of Post Graduate Medical Education & Research |
| Address |
College of nursing, OBG Department, Jawaharlal Institute of Post Graduate Medical Education & Research, Dhanvantri Nagar, Puducherry
PONDICHERRY
605006
India |
| Phone |
9994902057 |
| Fax |
|
| Email |
sivasankari.k.09@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research ,Dhanvantri nagar, Pondicherry, India, 605006 |
|
|
Primary Sponsor
|
| Name |
Pratyasa Banerjee |
| Address |
Jawaharlal Institute Of Post Graduate Medical Education & Research, college of nursing, OBG department, Dhanvantri nagar.Puducherr, 605006 |
| 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 |
| Pratyasa Banerjee |
Jawaharlal Institute of Postgraduate Medical Education and research |
Multipurpose hall, OBG department, College of nursing, JIPMER, Pondicherry,605006
Pondicherry
PONDICHERRY |
8768301652
banerjeepratyasa99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age group of 18-25 years of healthy boys and girls of B.Sc. nursing 1st year |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
sensitization programme on diseases caused by Human papilloma virus |
sensitization video will be provided on the content of diseases caused by Human papilloma virus and the vaccines available for prevention of HPV. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
healthy boys and girls of age between 18 years to 25 years of b.sc nursing 1st year students |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of sensitization programme on knowledge of diseases caused by Human Papilloma Virus among nursing students.
2.To evaluate the effect of sensitization programme on the attitude about vaccination against Human Papilloma Virus. |
At baseline and after 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To identify the socio demographic factors, associated with pre-test knowledge and attitude of diseases against Human Papilloma Virus among nursing students.
2.To correlate post-test knowledge and attitude of diseases against HPV among nursing students. |
1st day and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/10/2025 |
| 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="1"
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
|
This study aims to assess the knowledge and attitude of Human papilloma virus and its available vaccines among college students. Pre test will be held and then sensitization programme will be held to update their knowledge . After the sensitization programme their knowledge and attitude will be reassessed. Pre test and post test will be held through same pre tested semi-structured questionnaire. Pre test and post test knowledge and attitude will be compared to assess the effect of sensitization programme. Socio demographic variables associated with higher knowledge and attitude will be assessed. Hypothesis -Sensitization programme will improve the knowledge and attitude against diseases caused by HPV among the students. |