Here is the complete, Jharkhand-specific research proposal:
RESEARCH PROPOSAL
TITLE
Effect of a WhatsApp/Social Media-Based Educational Module on Mammography Knowledge, Clinical Confidence, and Intention to Recommend Appropriate Screening Among Medical Students in Jharkhand: A Pre-test Post-test Interventional Study
TITLE PAGE
| Field | Details |
|---|
| Institution | [Name of Medical College], Jharkhand |
| Department | Community Medicine / Radiology / Obstetrics & Gynecology |
| Study Design | Pre-test / Post-test quasi-experimental (single-group interventional) |
| Study Setting | Medical college(s), Jharkhand, India |
| Target Population | MBBS students, Years 1 to Final (Phase I-III) |
| Proposed Duration | 6 months |
| Date of Submission | August 2026 |
| Principal Investigator | [Name, Designation, Department] |
| Co-Investigators | [Names] |
| Guide / Supervisor | [Name, Designation] |
1. INTRODUCTION AND BACKGROUND
1.1 Global and National Burden of Breast Cancer
Breast cancer is the most frequently diagnosed cancer among women worldwide, with an estimated 2.3 million new cases recorded in 2022 (GLOBOCAN, 2022). India ranks third globally in absolute breast cancer incidence, with approximately 1,92,020 new cases in 2022 (WCRF, 2022; ASR: 26.6 per 1,00,000 women). Indian women are diagnosed at a younger age compared to Western counterparts - median age at diagnosis is 45-50 years versus 62 years in the United States - placing a significant burden on women in their productive years.
The National Cancer Registry Programme (NCRP) of India places Jharkhand under the pooled "East India" estimates. Compared to metropolitan urban registries such as Delhi, Mumbai, and Bangalore, the Eastern Indian region has limited cancer registration data, pointing to an under-recognized and possibly under-detected disease burden. The National Programme for Prevention and Control of Cancer (NPCC) and Ayushman Arogya Mandir (AAM) have scaled up breast cancer screening, with over 10.04 crore breast cancer screenings conducted under AAM by end of 2023. Despite this, coverage and follow-up remain inadequate in states like Jharkhand due to geographic challenges, limited specialist density, and low health literacy.
1.2 Mammography as a Screening Tool
Mammography is the gold standard for early breast cancer detection. Annual or biennial screening mammography reduces breast cancer mortality by 20-40% in the screened population. The 2024 USPSTF guidelines (the most recent major update) recommend biennial mammography for all average-risk women aged 40-74 years. The Indian Council of Medical Research (ICMR) and National Cancer Grid (NCG) have similarly endorsed clinical breast examination and mammography-based screening. However, uptake in states like Jharkhand is hindered by patient-level knowledge gaps and, critically, by inadequate counseling by healthcare providers.
A 2021 systematic review from India found widespread knowledge gaps regarding breast cancer screening among Indian women, with poor awareness of mammography as distinct from self-examination (Pal et al., J Cancer Res Ther, PMID: 34916359). A 2023 scoping review on female medical students found that even healthcare trainees hold significant misconceptions about mammography indications, frequency, and limitations (Tomic et al., J Med Life, PMID: 38585536).
1.3 Knowledge Gaps Among Medical Students
Medical students are the next generation of primary care physicians, gynecologists, surgeons, and community health workers. Their knowledge, confidence, and counseling behavior around mammography will directly influence women's screening decisions. Despite this, studies from South India confirm that breast cancer awareness - including screening knowledge - is significantly inconsistent even among MBBS students (Sajan et al., J Cancer Res Ther, PMID: 36412443).
Undergraduate medical curricula in India rarely dedicate structured time to mammography screening guidelines. Breast cancer content is distributed across surgery, radiology, and community medicine postings, but integration is inconsistent. By the time students enter clinical rotations, they may have absorbed fragmented, outdated, or guideline-discordant information.
1.4 WhatsApp as an Educational Platform in India
India has over 500 million WhatsApp users, the largest national user base in the world. In the medical education context, WhatsApp has emerged as a practical, accessible, low-cost channel for content delivery, especially in settings where internet bandwidth is variable and smartphone access is high. A scoping review by Coleman and O'Connor (BMC Med Educ, PMID: 31345202) established WhatsApp's educational utility for peer-to-peer case discussion, content sharing, and formative assessment. A 2024 study by Singh et al. from India demonstrated that a CME WhatsApp community improved knowledge sharing among medical professionals (PMID: 39227936). A landmark mixed-methods study (Pereira et al., JMIR mHealth, PMID: 32706726) showed that a WhatsApp-delivered educational intervention significantly improved breast cancer knowledge in women. Social media-based medical education is now recognized as a legitimate knowledge translation tool in mainstream literature (JAMA 2023, Ayers et al., PMID: 37642959).
In the Jharkhand context, where student populations are distributed across multiple colleges (Ranchi, Dhanbad, Hazaribagh, Jamshedpur), a WhatsApp-based delivery model is particularly appropriate because it:
- Requires no institutional LMS or broadband infrastructure
- Works on 4G mobile networks available across urban and semi-urban Jharkhand
- Reaches students asynchronously across campuses
- Is a platform students already use daily
1.5 Justification for This Study
No study has evaluated a WhatsApp/social media-delivered educational module specifically targeting mammography competency among medical students in Jharkhand or the broader Eastern India region. This study will generate local evidence, contribute to the development of a scalable digital teaching tool, and inform medical educators about a context-appropriate strategy for integrating breast cancer screening education into undergraduate training.
2. PROBLEM STATEMENT
Medical students in Jharkhand, like their peers across India, receive little structured, guideline-based training in mammography screening. This results in poor clinical knowledge, low confidence in patient counseling, and inconsistent intention to recommend appropriate screening - all of which contribute to late-stage breast cancer diagnoses at the community level. A WhatsApp-based educational module represents a low-cost, high-reach intervention that may bridge this gap, but its effectiveness has not been evaluated in this population.
3. AIM AND OBJECTIVES
3.1 Primary Aim
To evaluate the effect of a WhatsApp/social media-based educational module on mammography knowledge scores among MBBS students in Jharkhand, using a pre-test post-test design.
3.2 Specific Objectives
- To assess pre-intervention (baseline) mammography knowledge among MBBS students (Years 1-Final) in Jharkhand.
- To develop and deliver a structured WhatsApp-based educational module on mammography screening.
- To measure the change in mammography knowledge scores from pre-test to post-test.
- To assess pre- and post-intervention self-reported clinical confidence in discussing mammography with patients.
- To evaluate pre- and post-intervention intention to recommend appropriate mammography screening using clinical vignettes.
- To compare knowledge, confidence, and intention scores across academic years (Phase I, II, III/Final).
- To identify baseline predictors of mammography knowledge (year of study, gender, prior breast cancer teaching exposure).
4. RESEARCH HYPOTHESES
| Hypothesis | Statement |
|---|
| H1 (Primary) | MBBS students will show a statistically significant improvement in mammography knowledge scores after the WhatsApp educational module |
| H2 | Students will report significantly higher clinical confidence in discussing mammography post-intervention |
| H3 | Intention to recommend appropriate mammography screening will be significantly higher post-intervention |
| H4 | Final-year students will have significantly higher baseline knowledge compared to Phase I students |
| H0 (Null) | The WhatsApp module will produce no significant change in knowledge, confidence, or screening recommendation intention |
5. STUDY DESIGN
Design: Single-group, pre-test / post-test quasi-experimental study (within-subjects design)
Study flow:
Recruitment
|
Pre-test Questionnaire (Google Forms link shared via WhatsApp)
|
WhatsApp Educational Module (delivered over 3-5 days in a dedicated study group)
|
Post-test Questionnaire (same Google Forms link, sent on Day 6-7)
|
[Optional] 4-week follow-up short test (knowledge retention, sub-study)
Rationale for single-group design: Withholding a potentially beneficial educational intervention from a control group is ethically unjustifiable in an educational setting. A waitlist control design is offered as an optional enhancement (see Section 13).
6. STUDY SETTING
- Primary setting: Medical college(s) in Jharkhand, India
- Examples: Rajendra Institute of Medical Sciences (RIMS), Ranchi; MGM Medical College, Jamshedpur; Patliputra Medical College, Dhanbad; Hazaribagh Medical College
- Mode of intervention delivery: WhatsApp group(s) and/or Instagram/Telegram (social media)
- Mode of data collection: Online questionnaire (Google Forms / KoBoToolbox / REDCap)
7. STUDY POPULATION
7.1 Target Population
MBBS students currently enrolled in any year (Phase I through Phase III/Final Year) at medical colleges in Jharkhand.
7.2 Inclusion Criteria
- Currently enrolled MBBS student at a medical college in Jharkhand
- Owns a smartphone with WhatsApp access
- Willing to provide written/electronic informed consent
- Available to complete both pre-test and post-test within the study period
7.3 Exclusion Criteria
- Interns (completed all clinical phases) - to avoid ceiling effect from extensive clinical exposure
- Students who have completed a dedicated breast radiology posting within the last 3 months
- Students who complete only the pre-test or only the post-test (incomplete pairs excluded from analysis)
- Students who join the WhatsApp group but do not view any module content (tracked via read receipts or a mid-module engagement quiz)
8. SAMPLE SIZE CALCULATION
Based on paired t-test for pre-post within-subjects comparison:
- Expected mean improvement in knowledge score: 15% (based on Pereira et al., 2020; Pal et al., 2021)
- Estimated standard deviation of the difference: 20%
- Level of significance (alpha): 0.05 (two-tailed)
- Power (1-beta): 80%
Using the paired-samples formula:
n = (Z_(alpha/2) + Z_beta)^2 x SD^2 / d^2 = (1.96 + 0.84)^2 x 400 / 225 = approximately 50
- Adding 20% for attrition (non-response, incomplete data): minimum n = 60
- Target enrollment for subgroup analysis across academic years: n = 100 students
9. SAMPLING AND RECRUITMENT
| Step | Method |
|---|
| Institutional access | Permission from Principal/Dean of participating college(s) |
| Class-level recruitment | Class representatives (CRs) approached in each year; study WhatsApp group link shared |
| Online recruitment | Study QR code and Google Forms pre-screening link posted on college notice boards and class WhatsApp groups |
| Snowball sampling | Students encouraged to forward the group link to peers in other years and colleges |
| Enrollment confirmation | Students who complete informed consent form and pre-test are formally enrolled |
Incentive: Participants will receive a personalized e-certificate of participation and a PDF pocket guide summarizing current mammography screening guidelines (ICMR/USPSTF/ACS).
10. THE WHATSAPP/SOCIAL MEDIA EDUCATIONAL MODULE
10.1 Development Team
Developed by the research team including:
- 1 Radiologist (mammography content, imaging interpretation)
- 1 Community Medicine Faculty (screening guidelines, epidemiology)
- 1 Obstetrics & Gynecology Faculty (clinical application)
- 1 Medical Education expert (instructional design)
Reviewed by 2 external subject matter experts before deployment.
10.2 Delivery Platform
- Primary: A dedicated WhatsApp group (one per college/batch)
- Supplementary: Telegram channel (for document archiving) and/or Instagram close friends / broadcast list for infographic delivery
10.3 Module Duration
Content delivered over 3-5 consecutive days (one topic per day), in a "micro-learning" format. Total estimated engagement time: 20-30 minutes across all days.
10.4 Content Delivery Schedule
| Day | Topic | Format |
|---|
| Day 1 | Breast Cancer in India and Jharkhand - Burden, Epidemiology, Why it Matters | Infographic + 2-min voice note |
| Day 2 | What is Mammography? - Technology, BI-RADS, Sensitivity/Specificity | Illustrated PDF card + short video clip (<3 min) |
| Day 3 | Screening Guidelines - USPSTF 2024, ACS, ICMR/NCG, Who to Screen, When to Start | Guideline comparison table (image card) + voice note |
| Day 4 | Benefits, Limitations, and Shared Decision-Making - False positives, Overdiagnosis, Talking to Patients | Scenario-based story post + FAQ card |
| Day 5 | Summary, Key Takeaways, and Downloadable Resource | Summary infographic + downloadable PDF pocket guide |
10.5 Content Formats
- Designed infographic cards (created in Canva)
- Short pre-recorded audio explanations (voice notes, 2-3 minutes each)
- Guideline comparison table (image format)
- 1-2 short video clips (<3 minutes, hosted on YouTube and shared as links)
- Clinical scenario-based story posts (text)
- End-of-module downloadable PDF guide
10.6 Instructional Design Principles Applied
- Micro-learning: Content broken into small daily doses to reduce cognitive load
- Health Belief Model: Content frames screening as personally relevant and feasible
- Adult learning theory (Andragogy): Learners understand the "why" before the "how"
- Spaced repetition: Key guidelines reinforced across multiple days
10.7 Monitoring Engagement
- WhatsApp read receipts (double blue ticks) to confirm message delivery and opening
- A short 3-question formative quiz sent on Day 3 (via Google Forms link) to check mid-module engagement
- Students who do not open any messages by Day 3 receive a reminder
11. DATA COLLECTION INSTRUMENT
The questionnaire is administered via Google Forms, with the link shared in the WhatsApp group at:
- Time 0 (Pre-test): Before the module begins (Day 0)
- Time 1 (Post-test): 24-48 hours after Day 5 module completion (Day 6-7)
11.1 Questionnaire Structure
Section A: Sociodemographic and Background Information (Pre-test only)
| Variable | Item Type |
|---|
| Age | Numeric |
| Gender | Male / Female / Prefer not to say |
| MBBS Phase / Year | Phase I / II / III / Final |
| Medical college and district (Jharkhand) | Dropdown |
| Prior teaching on breast cancer screening (yes/no) | Binary |
| Prior clinical posting - Radiology or Surgery (yes/no) | Binary |
| Personal/family history of breast cancer (yes/no) | Binary |
Section B: Mammography Knowledge (Pre-test and Post-test) - PRIMARY OUTCOME
- 20 multiple-choice questions (single best answer) covering:
| Topic Area | No. of Questions |
|---|
| Breast cancer epidemiology (India, risk factors) | 3 |
| Indications and contraindications for mammography | 2 |
| Screening initiation age and frequency per major guidelines | 4 |
| BI-RADS classification and result interpretation | 3 |
| Sensitivity, specificity, false positives, overdiagnosis | 3 |
| High-risk screening (BRCA, family history, dense breasts) | 2 |
| Role of physician in screening counseling | 2 |
| Practical aspects (referral, radiation dose, cost) | 1 |
- Scoring: 1 mark per correct answer; 0 for incorrect/unanswered
- Total knowledge score: 0-20 (converted to percentage for analysis)
Section C: Clinical Confidence (Pre-test and Post-test) - SECONDARY OUTCOME
5-item Likert scale (1 = Not at all confident, 5 = Extremely confident):
- Explaining what mammography is and why it is used
- Advising a patient on when to start mammography screening
- Interpreting a mammography report category (BI-RADS) for a patient
- Addressing a patient's concerns about radiation or false positives
- Identifying a patient who needs high-risk screening
Composite confidence score = mean of 5 items (range 1.0 - 5.0)
Section D: Intention to Recommend Appropriate Screening (Pre-test and Post-test) - SECONDARY OUTCOME
3 clinical vignettes, each with 4 answer choices (1 correct, 3 distractors):
- Vignette 1: A 42-year-old woman from Ranchi with no family history or risk factors asks about breast cancer screening. What do you advise?
- Vignette 2: A 36-year-old woman with a confirmed BRCA1 mutation and no prior screening asks when to begin mammography. What is the most appropriate recommendation?
- Vignette 3: A 55-year-old woman, biennial mammography done 18 months ago, reports no symptoms. Her report showed BI-RADS 3. What is the most appropriate next step?
Score: 1 point per correct recommendation; total vignette score = 0-3
11.2 Questionnaire Validation
| Step | Method | Standard |
|---|
| Content validity | Expert panel review (3 radiologists, 1 gynaecologist, 1 community medicine faculty) | Item Content Validity Index (I-CVI) > 0.80 |
| Face validity | Review by 5 MBBS students from a non-participating institution | Clarity and comprehensibility |
| Pilot test | 15 students from one class (excluded from main study) | Item difficulty index 0.30-0.80; discrimination index > 0.20 |
| Internal reliability | Cronbach's alpha for knowledge domain and confidence scale | Alpha > 0.70 acceptable |
12. OUTCOME MEASURES SUMMARY
| Outcome | Instrument | Timepoint | Type |
|---|
| Mammography knowledge score (0-20) | 20-item MCQ | Pre + Post | Primary |
| Mean change in knowledge score | Post - Pre | Post | Primary |
| Clinical confidence score (1.0-5.0) | 5-item Likert | Pre + Post | Secondary |
| Screening recommendation intention (0-3) | 3 clinical vignettes | Pre + Post | Secondary |
| Knowledge by academic year | Subgroup of MCQ | Pre + Post | Secondary |
| Module engagement rate | WhatsApp read receipts | During module | Process |
| 4-week knowledge retention | 10-item MCQ subset | 4 weeks post | Exploratory |
13. DATA ANALYSIS PLAN
13.1 Descriptive Statistics
- Categorical variables: frequency (n) and percentage (%)
- Continuous variables: mean ± SD or median [IQR] based on distribution
- Baseline characteristics tabulated by academic year
13.2 Primary Analysis (Knowledge Score)
- Normality testing: Shapiro-Wilk test
- If normal: Paired samples t-test (pre vs. post knowledge score)
- If non-normal: Wilcoxon signed-rank test
- Effect size: Cohen's d (paired version) - small: 0.2, medium: 0.5, large: 0.8
- Significance level: p < 0.05 (two-tailed); 95% CI reported
13.3 Secondary Analyses
| Analysis | Test |
|---|
| Confidence score (pre vs. post) | Paired t-test or Wilcoxon signed-rank |
| Vignette intention score (pre vs. post) | Wilcoxon signed-rank (ordinal, 0-3) |
| Knowledge by academic year | One-way ANOVA (or Kruskal-Wallis) at baseline; repeated measures if longitudinal |
| Gender difference in knowledge | Independent t-test (pre-test score) |
| Predictors of baseline knowledge | Multiple linear regression (year, gender, prior exposure) |
| Proportion achieving >=60% post-test | McNemar's test (proportion at pre vs. post) |
13.4 Software
- IBM SPSS v29, R (v4.4), or STATA 17
- All tests two-tailed; alpha = 0.05
- Missing data: Per-protocol analysis (complete pairs only); sensitivity analysis with last observation carried forward if >5% missing
14. ETHICAL CONSIDERATIONS
| Issue | Measure |
|---|
| Ethics approval | Institutional Ethics Committee (IEC), [Medical College Name], Jharkhand - approval obtained before recruitment |
| Informed consent | Digital informed consent form embedded at start of Google Forms pre-test questionnaire; participation is voluntary |
| Anonymity | No name collected; unique study ID assigned; responses stored on password-protected Google Drive / KoBoToolbox server |
| Right to withdraw | Students may leave the WhatsApp group and withdraw at any point without academic consequence |
| Data storage | Data stored for 5 years per ICMR guidelines; accessible only to principal investigator and co-investigators |
| No withheld benefit | All participants receive the full module - there is no untreated control group |
| Conflict of interest | None declared; no pharmaceutical or commercial funding |
| Registration | Study registered on CTRI (Clinical Trials Registry - India) prior to participant enrollment |
Regulatory reference: ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017, updated 2023).
15. LIMITATIONS
- No randomized control group: Cannot exclude test-retest effect (students may recall pre-test questions). Mitigation: some post-test items will use paraphrased stems and different distractor sets.
- Self-selection bias: Volunteers may be more motivated or already more knowledgeable than non-participants.
- WhatsApp engagement verification: Read receipts confirm message opening, not actual content engagement. Mitigation: mid-module formative quiz (Day 3) as an engagement checkpoint.
- Social desirability bias: Confidence and intention are self-reported and may not reflect actual clinical behavior.
- Single-college limitation: If conducted at one institution, results may not generalize to all Jharkhand medical colleges. Mitigation: multi-college recruitment where feasible.
- Short follow-up: Long-term knowledge retention and actual counseling behavior in clinical practice are not assessed.
Optional design enhancement - Waitlist control: If a second college can be recruited simultaneously, College A receives the module first (Month 3-4); College B serves as the waitlist control receiving the module in Month 5. This allows a between-group comparison while ensuring eventual benefit to all participants.
16. EXPECTED OUTCOMES AND SIGNIFICANCE
| Expected Finding | Significance |
|---|
| Significant increase in knowledge scores post-intervention | Validates WhatsApp as a viable mammography education tool in Jharkhand |
| Significant improvement in clinical confidence | Supports future deployment for counseling skills training |
| Improved vignette-based recommendation accuracy | Suggests downstream potential to improve patient counseling quality |
| Year-based variation in baseline knowledge | Informs curriculum design - identifies the optimal year to introduce the module |
Broader impact:
- Provides the first locally-generated evidence on mammography education among Jharkhand medical students
- Produces a validated, reusable WhatsApp mammography module deployable at zero cost across other Jharkhand or East Indian medical colleges
- The validated questionnaire serves as a standalone assessment tool for future curriculum evaluation
- Informs ICMR / NMC (National Medical Commission) curriculum revision discussions on preventive oncology education
17. STUDY TIMELINE
| Month | Activity |
|---|
| Month 1 | IEC application submission; module content development; questionnaire drafting |
| Month 2 | Expert review (CVI); pilot testing (n=15); questionnaire finalization; CTRI registration |
| Month 3 | Recruitment; WhatsApp group setup; informed consent collection |
| Month 3-4 | Pre-test data collection; module delivery (Days 1-5); post-test data collection |
| Month 5 | Optional 4-week follow-up knowledge test; data cleaning |
| Month 6 | Statistical analysis; manuscript writing; dissemination |
18. BUDGET (ESTIMATED)
| Item | Cost (INR) |
|---|
| Module content design (Canva Pro subscription, 3 months) | ₹ 3,000 |
| Video recording and editing (if required) | ₹ 2,000 |
| Google Workspace / KoBoToolbox (data collection) | ₹ 0 (free tier) |
| CTRI registration | ₹ 0 (free) |
| Printing (consent forms, coordinator copies) | ₹ 500 |
| Participant e-certificates and pocket guide printing | ₹ 1,000 |
| Miscellaneous (communication, internet) | ₹ 1,000 |
| Total (estimated) | ₹ 7,500 (~USD 90) |
19. REFERENCES (KEY)
- Nicholson WK et al. Screening for Breast Cancer: USPSTF Recommendation Statement. JAMA. 2024;331(22):1918-1930. USPSTF 2024
- Pal A et al. Knowledge, attitude, and practice towards breast cancer and its screening among women in India: A systematic review. J Cancer Res Ther. 2021. PMID: 34916359
- Tomic M et al. Exploring female medical students' knowledge, attitudes, practices related to breast cancer screening: a scoping review. J Med Life. 2023. PMID: 38585536
- Pereira AAC et al. Effects of a WhatsApp-Delivered Education Intervention to Enhance Breast Cancer Knowledge in Women. JMIR mHealth uHealth. 2020. PMID: 32706726
- Coleman E, O'Connor E. The role of WhatsApp in medical education; a scoping review and instructional design model. BMC Med Educ. 2019. PMID: 31345202
- Singh NK et al. Leveraging WhatsApp as a collaborative medical information and knowledge sharing tool - insights from a CME WhatsApp community. BMC Med Educ. 2024. PMID: 39227936
- Sajan AS et al. Comparing the knowledge and awareness of cervical and breast cancer among medical and nonmedical students of a private institution in South India. J Cancer Res Ther. 2022. PMID: 36412443
- Ayers JW et al. #MedEd: Medical Education and Knowledge Translation on Social Media. JAMA. 2023. PMID: 37642959
- Krishnan S et al. Cancer incidence estimates for 2022 and projection for 2025: Result from NCRP India. Indian J Med Res. 2022;156:598-607.
- ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: ICMR; 2017 (Updated 2023).
APPENDICES (PLANNED)
| Appendix | Content |
|---|
| A | Full pre-test/post-test questionnaire (Sections A-D) |
| B | Day-by-day WhatsApp module content plan and sample infographic cards |
| C | Informed consent form (English + Hindi) |
| D | IEC application proforma |
| E | CTRI registration summary |
| F | Guideline comparison table: USPSTF 2024, ACS, ACR, ICMR/NCG |
| G | Pilot testing report (difficulty index, discrimination index, Cronbach's alpha) |
Checklist Before Submission
This proposal is ready for submission to your Institutional Ethics Committee. The full title for the protocol can be finalized as:
"Effect of a WhatsApp/Social Media-Based Educational Module on Mammography Knowledge, Clinical Confidence, and Intention to Recommend Appropriate Screening Among MBBS Students in Jharkhand: A Pre-test Post-test Interventional Study"