| CTRI Number |
CTRI/2025/09/095122 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NON RANDOMIZED] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Effectiveness of an Educational Intervention on Knowledge, Attitude, and Readiness for health related advices towards vulvovaginal discharge among adolescent girls : A Quasi-experimental Study" |
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Scientific Title of Study
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Effectiveness of an educational intervention on awareness ,attitude and readiness for health-related advices towards vulvovaginal discharge among adolescent girls at selected tertiary care hospital. |
| Trial Acronym |
"VVD-KAR Study" Vulvovaginal Discharge – Knowledge, Attitude, and Readiness Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nill |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MS ROZEE ANEES |
| Designation |
PG STUDENT |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY LUCKNOW UP |
| Address |
KHAUDIYA
MUSAFIRKHANA
Sultanpur
UTTAR PRADESH
227813
India |
| Phone |
9026018785 |
| Fax |
0 |
| Email |
rozeeanees@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MRS TANIMA VERMA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY LUCKNOW UP |
| Address |
LUCKNOW
LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
918601676259 |
| Fax |
|
| Email |
Tanimaverma9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MRS SUMAN LATA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY, LUCKNOW , UP |
| Address |
Lucknow
Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
919729764723 |
| Fax |
0 |
| Email |
lata.suman83@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
KING GEORGE MEDICAL UNIVERSITY LUCKNOW |
| Address |
KING GEORGE MEDICAL UNIVERSITY ,SHAH MINA ROAD ,CHOWK ,LUCKNOW ,UTTAR PRADESH ,INDIA -226003 |
| Type of Sponsor |
Other [] |
|
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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 |
| ROZEE ANEES |
KING GEORGE MEDICAL UNIVERSITY ,QUEEN MARY HOSPITAL ,LUCKNOW |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, ADOLESCENT UNIT ,LUCKNOW ,UTTAR PRADESH ,INDIA -226003
Lucknow
UTTAR PRADESH |
9026018785
rozeeanees@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGE MEDICAL UNIVERSITY UP INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
vaginal discharge |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EDUCATION intervention |
Type of intervention: Educational Name of intervention: Pamphlet-Based Health Education on Vaginal Discharge Description of intervention:This educational intervention is aimed at improving the knowledge and awareness regarding vaginal discharge among adolescent girls aged 12–19 years. The intervention involves a one-time distribution of a specially designed, printed pamphlet containing key information about normal and abnormal vaginal discharge, its causes, symptoms of infection, hygiene practices, and the importance of seeking timely medical care.Mode of delivery Printed pamphlet
One-on-one distribution in the OPD Optional brief verbal reinforcement (5–10 minutes)
Frequency and duration: One-time educational intervention
Duration per participant: ~10 minutes . No repeated sessions or follow-up distribution
Target population:Adolescent girls aged 12–19 years attending the outpatient department of a selected tertiary care hospital |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1 Adolescent girls who are able to read and write Hindi or English.
2 Adolescent girls who willingly participate and ready to give consent during the period of data collection.
3 Adolescent girls who have abnormal vulvovaginal problem.
4 Adolescent girls who came to gynae OPD other than abnormal vulvovaginal discharge.
|
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| ExclusionCriteria |
| Details |
Exclusion criteria -
•The study will exclude the adolescent who are psychologically deprived .
•Adolescent girls who are not willing to participate.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| •To assess the pre-test awareness level, attitude and readiness for Health-Related Advices towards vulvovaginal discharge among adolescent girls. |
1 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of an educational intervention on awareness, attitude & readiness for Health-Related Advices towards vulvovaginal discharge.
To find-out the association between pre-test level of awareness on vulvovaginal discharge among adolescent girls with their selected socio-demographic variable.
|
1 weeks |
| To evaluate the effectiveness of an educational intervention on awareness, attitude & readiness for Health-Related Advices towards vulvovaginal discharge.To find-out the association between pre-test level of awareness on vulvovaginal discharge among adolescent girls with their selected socio-demographic variable. |
1 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
13/10/2025 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
According to the WHO, 75% of women worldwide have experienced vaginal discharge at least once, while 45% have had it twice.
In Indonesia, 90% of women are at risk due to the country’s tropical climate, which allows fungi to grow easily, leading to yeast infections and many cases of vaginal discharge.
The CDC reported in 2020 that about 29.2% of women aged 14 to 49 in the United States have bacterial vaginosis, which affects around 21.2 million women.
A study by Singamsetty and Sravani (2021) in coastal Andhra Pradesh found bacterial vaginosis to be the most common condition (27-47%), followed by candidiasis (6.25-29.75%) and trichomoniasis (4.3-25%).
Common symptoms included vulvar itching (50.61%), curdy discharge (61.25%), painful urination (47.5%), and painful intercourse.
City of Padang showed that having more information helps people understand and prevent vaginal discharge.
A study by Abdelnaem et al. found that 59.8% of adolescents got information about vaginal discharge from their parents.This highlights the important role parents, especially mothers, play in the reproductive health development of their children.
Female students are at a higher risk of making unhealthy choices that can affect their health.
Uninformed students can develop wrong or incomplete ideas about lifestyle, physical activity, and fitness.
Delay in seeking medical help for abnormal vaginal discharge can lead to serious issues like infertility, ectopic pregnancies, and advanced cervical cancer.
People with good personal hygiene knowledge and attitudes are more likely to adopt healthy behaviors.
If personal hygiene, especially for the vaginal area, is incorrect, it can make a person more vulnerable to bacterial, viral, and fungal infections. Vulvovaginal discharge is a common symptom in women that can be normal or indicate infection. Causes include physiological changes, bacterial vaginosis, yeast infections (candidiasis), trichomoniasis, and other conditions. A typical study involves examining women with discharge to identify the underlying cause using clinical exams, vaginal pH testing, and microscopic analysis. Results often show bacterial vaginosis as the most frequent cause, followed by candidiasis and trichomoniasis. Some women may have mixed infections. Accurate diagnosis is crucial for effective treatment and to prevent complications.
Vulvovaginal discharge is a common clinical complaint with multiple causes, predominantly infections like bacterial vaginosis, candidiasis, and trichomoniasis. Accurate diagnosis through clinical evaluation and appropriate laboratory investigations is essential to identify the specific etiology. Timely and targeted treatment based on diagnosis improves patient outcomes and prevents complications. Awareness and early management of vulvovaginal infections can significantly enhance women’s reproductive health and quality of life.
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