| CTRI Number |
CTRI/2018/08/015225 [Registered on: 07/08/2018] Trial Registered Prospectively |
| Last Modified On: |
02/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Survey study in menstrual hygiene in high school girls |
|
Scientific Title of Study
|
EFFECTIVENESS OF A STRUCTURED EDUCATION PROGRAM ON MENSTRUAL HYGIENE KNOWLEDGE ATTITUDE AND PRACTICE AMONG HIGH SCHOOL GIRLS OF URBAN AND RURAL AREAS OF BELAGAVI |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Mahajan |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya And Research Center Shahapur Belagavi Karnataka 590003 |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya And Research Center
Shahapur Belagavi 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9980740912 |
| Fax |
|
| Email |
93m.poo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Mahajan |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya And Research Center Shahapur Belagavi Karnataka 590003 |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya And Research Center
Shahapur Belagavi 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9980740912 |
| Fax |
|
| Email |
93m.poo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Sagare |
| Designation |
Reader of Department of Swasthavritta |
| Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya And Research Center |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya And Research Center
Shahapur Belagavi 590003
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9844586894 |
| Fax |
|
| Email |
sandeepsagare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M K Ayurveda mahavidyalaya and research center Shahpur Belagavi Karnataka 590003 |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
Shri B M K Ayurveda mahavidyalaya and research center Shahpur Belagavi Karnataka 590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pooja Mahajan |
Government and Private High school |
KAHERs Shri B M K Ayurveda Mahavidyalaya and Hospital
Swasthavritta OPD No 2 and Ipd
Belagavi karnataka 590003
Belgaum
KARNATAKA |
9980740912
93m.poo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHERs Shri B M K Ayurveda Mahavidyalaya and KLE Ayurveda Hospital INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School going girls, aged between 13 to 16 years in and around the schools of Belagavi
Attained menarche.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education |
Health Education |
| Comparator Agent |
Only Observation |
Only Observation |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
School going girls, aged between 13 to 16 years attained menarche in and around the schools of Belagavi
|
|
| ExclusionCriteria |
| Details |
Cognitive impairment, Congenital deformities
Not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knowledge attitude and practice about menstrual hygiene in school going children will be known and
Effectiveness of education program on menstrual hygiene |
0th, 45th, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "600"
Final Enrollment numbers achieved (India)="600" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2018 |
| Date of Study Completion (India) |
20/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
SUMMARY
The
present study entitled “Effectiveness of a Structured Education Program on
Menstrual Hygiene, Knowledge, Attitude and Practice among High School Girls of
Urban and Rural areas of Belagaviâ€
1. Introduction
It includes
brief views of concepts of Rajaswalaparicharya, menstrual hygiene, menstrual
disorders and the need for the study
2. Review of literature
The literary
review includes Historical review, Anatomy of external genital organs,
conceptual review of Rajaswalaparicharya, menstruation, menstrual cycle,
menstrual hygiene, and menstrual hygiene management
Historical
review- Explains about Artava and its various historical aspects of and
references of Rajaswalaparicharya and menstrual hygiene evolution.
Anatomy of
external genital organs- Explanation about both Ayurvedic and modern view of
external genital organs.
Conceptual
review- the conceptual review includes brief explanations about menstrual
hygiene.
Review of Rajaswalaparicharya-
it contains explanation about Rajaswalaparicharya mentioned in classics.
Menstruation-
deals with explanation about menstruation and physiology of menstrual
cycle.
Menstrual
hygiene- various aspects of menstrual hygiene, menstrual hygiene management and menstrual hygiene day were
explained.
3. Methodology- The third part comprises of
methodology of the present study which was carried out on 600 subjects of
adolescent age group. This covers of materials and method, study design, inclusion
criteria, exclusion criteria and consort chart.
4. Observation
and results – observation
deals with the tabular representation, which are documented both in number and
percentages. The study results were accessed with appropriate statistical methods
and represented with graphs and chart.
5. Discussion
This part deals
with discussion on literary part, observation and results.
6. Conclusion
Conclusion deals
with the conclusions drawn on observations made in the study and the results.
|