| CTRI Number |
CTRI/2023/09/057805 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a Health education program on knowledge,attitude and practices of Menstrual health and hygiene in adolescent school children- A randomized control trial |
|
Scientific Title of Study
|
Effect of a Structured Health Education Program on Knowledge, attitude, and
practices of Menstrual Health and Hygiene in adolescent school children in Urban Areas of Pune City- A Randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagarika Shashank Patwardhan |
| Designation |
Postgraduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy,11/12,Thube Park,Shivaji Nagar,Pune-411005
Department of Community Physiotherapy Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
Pune
MAHARASHTRA
411005
India |
| Phone |
7030890214 |
| Fax |
|
| Email |
sagarikapatwardhan123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suroshree Mitra |
| Designation |
Head of Department and Professor Community Physiotherapy |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy,11/12,Thube Park,Shivaji Nagar,Pune-411005
Department of Community Physiotherapy Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
Pune
MAHARASHTRA
411005
India |
| Phone |
9284122655 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sagarika Shashank Patwardhan |
| Designation |
Postgraduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy,11/12,Thube Park,Shivaji Nagar,Pune-411005
Department of Community Physiotherapy Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy
Pune
MAHARASHTRA
411005
India |
| Phone |
7030890214 |
| Fax |
|
| Email |
sagarikapatwardhan123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for orthopedics and rehabilitation college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for orthopedics and rehabilitation college of physiotherapy |
| Address |
11/12,Thube park,Shivajinagar,Pune-411005 |
| Type of Sponsor |
Private medical college |
|
|
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 Sagarika Patwardhan |
Sagarika Patwardhan |
Community Department of Sancheti Institute of Physiotherapy and Hospital for Orthopedics and Rehabilitation
Pune
MAHARASHTRA |
7030890214
sagarikapatwardhan123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy subjects
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flipbook on menstrual health and hygiene |
A information booklet about menstrual health and hygiene will be administered in schools. Duration of the study is 6 weeks. |
| Intervention |
Structured health education program on menstrual health and hygiene |
A 6 weeks structured health education program will be conducted in schools one hour session per week for six weeks.Duration of the study is 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Adolescent school going girls who have attained menarche and boys in urban areas of Pune city.
2. Adolescent school going girls and boys aged 11-15 years,6-9th standards in english medium co education secondary school government and private affiliated to SSC,CBSE and ICSE boards in urban areas of Pune city who are willing to participate in the study and present on the day of data collection
|
|
| ExclusionCriteria |
| Details |
adolescent girls who have not attained menarche. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Pelvic & Menstrual health Menstrual hygiene questionnaire |
The Pelvic & Menstrual health Menstrual hygiene questionnaire will be administered in both groups at beginning of study and after 6 weeks of study duration when the study ends. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcomes |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="492"
Sample Size from India="492"
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)
|
28/09/2023 |
| 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="0"
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
|
Title-Effect of a Structured Health Education Program on Knowledge, attitude, and practices of Menstrual Health and Hygiene in adolescent school children in Urban Areas of Pune city- A Randomized control trial
Menstruation is defined as the natural physical process of releasing blood and related matter from the uterus through the vagina as part of the menstrual cycle, which occurs once a month and lasts one to seven days.WHO globally and government of India are taking efforts to improve the Despite the government’s multiple initiatives and Yojanas, as well as making menstruation health education mandatory in schools, there are still gaps in knowledge and poor menstrual hygiene practices.As a result, it is necessary to assess adolescents’ knowledge, attitudes, and practices regarding menstrual health and hygiene and rectify them by educating so that the habit of healthy practices would be continued in the future preventing complications.Previous research only targeted girls as programme stakeholders, but there has been little research that engages both adolescent girls and boys to educate them about menstrual health and hygiene.There yet exists sparse number of programmes that deliver systematic health education about menstrual hygiene and health to both genders-girls and boys..Investing in adolescent children by educating them about menstrual health and hygiene may thus offer three benefits in terms of well-being: for the girls, the women they will become, and the following generation.The inclusion of boys in the programme would educate them on the menstrual cycle and related myths, as well as provide support to the girls by establishing a safe and healthy environment and community and promoting dignified menstruation for the girls. H1: There will be change in knowledge,attitude and practices about menstrual health and hygiene after the induction of a structured health educational program among adolescent school children in Urban areas of Pune City. Ho: There will be no change in knowledge,attitude and practices about menstrual health and hygiene after the induction of a structured health educational program among adolescent school children in Urban areas of Pune City. Aim: To find out the change in Knowledge,attitude and practices of menstrual health and hygiene among adolescent school children in Urban Areas of Pune city after the induction of a structured health educational program on Menstrual health and hygiene. Objective: 1.To assess the existing knowledge,attitude and practices about menstrual health and hygiene among adolescent school going children in Urban Areas of Pune city after administration of “The Adolescent Pelvic and Menstrual Health,Menstrual hygiene†questionnaire. 2.To evaluate the change in Knowledge,attitude and practice of menstrual health and hygiene among adolescent school children from Urban areas of Pune city after the induction of a structured health educational program on Menstrual health and hygiene. 3. To evaluate the change in Knowledge,attitude and practice of menstrual health and hygiene among adolescent school children from Urban areas of Pune city after the distribution of a flipbook (information booklet) on Menstrual health and hygiene. 4. To compare the change in Knowledge,attitude and practice of menstrual health and hygiene among adolescent school children from Urban areas of Pune city after the induction of a structured health educational program on Menstrual health and hygiene and after distribution of the flipbook (information book). The study will span for 6 weeks duration. Group A the interventional group will be given a 6 weeks structured health educational program on menstrual health and hygiene one hour each week. Group B will be the control group which will receive information booklet on menstrual health and hygiene. |