| CTRI Number |
CTRI/2025/10/096203 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Awareness-Based Education Regarding Pap Smear Screening On Knowledge Attitude And Readiness |
|
Scientific Title of Study
|
Awareness-Based Education Regarding Pap Smear Screening On Knowledge Attitude And Readiness Among Women of a selected Community In Mangalore,Dakshina Kannada. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asiya Banu |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Nursing College |
| Address |
Yenepoya Nursing College,Naringana, Mangalore-575018
Yenepoya Nursing College,Naringana,Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8123578037 |
| Fax |
|
| Email |
asiyabanu1602@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asiya Banu |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Nursing College |
| Address |
Yenepoya Nursing College, Naringana,Mangalore-575018
Yenepoya Nursing College,Naringana,Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8123578037 |
| Fax |
|
| Email |
asiyabanu1602@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asiya Banu |
| Designation |
Post Graduate |
| Affiliation |
Yenepoya Nursing College |
| Address |
Yenepoya Nursing College, Naringana,Mangalore-575018
Yenepoya Nursing College,Naringana,Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8123578037 |
| Fax |
|
| Email |
asiyabanu1602@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Asiya Banu |
| Address |
Yenepoya Nursing College,Naringana,Mangalore-575018 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Janet Miranda |
Kotekar |
Yenepoya Nursing College,Naringana,Mangalore-575018
Dakshina Kannada
KARNATAKA |
9886933804
janetmiranda@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Commitee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
those who are willing to participate in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pap Smear |
pap Smear screening |
| Comparator Agent |
Single arm study so control group |
no intervention |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 21 to 65 years
Women who have never undergone a Pap smear screening.
Women who can read and write Kannada or English
|
|
| ExclusionCriteria |
| Details |
Women diagnosed with cervical cancer
Women who have undergone hysterectomy
Pregnant women
pueriperium mother
Women with diagnosed uterine prolapse
women who is currently diagnosed or undergoomg treatment for STDs |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge and attitude about pap smear screening |
knowledge and attitude about pap smear screening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| readiness for pap smear screening |
pre test
post test |
|
|
Target Sample Size
|
Total Sample Size="402"
Sample Size from India="402"
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)
|
28/10/2025 |
| 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="1"
Months="11"
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
|
the present study aims to evaluate the effectiveness of an awareness based educational intervention on thee knowledge, readiness, and attitude of women regarding pap smear screening n a selected community. the study findings are expected to improve awareness and promote positive health seeking behaviour for cervical cancer prevention among community women. |