| CTRI Number |
CTRI/2025/03/082631 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Helping Women Understand and Choose Family Planning: Nurse-Directed Counseling Study" |
|
Scientific Title of Study
|
A study to assess the effectiveness of Nurse Directed counselling on family planning counselling on knowledge and Attitude and adoption rate among Eligible couple attending the OBG OPD at a selected Tertiary care centre in south India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Muthuvenkatachalam S |
| Designation |
Associate professor |
| Affiliation |
AIIMS, MANGALAGIRI |
| Address |
002, fourth floor, college of Nursing AIIMS, MANGALAGIRI
Guntur
ANDHRA PRADESH
522502
India |
| Phone |
9410366146 |
| Fax |
|
| Email |
drmuthu@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYA M |
| Designation |
NURSING TUTOR |
| Affiliation |
AIIMS, MANGALAGIRI |
| Address |
108, first floor, college of Nursing AIIMS, MANGALAGIRI, GUNTUR DISTRICT,ANDHRAPRADESH,
Guntur
ANDHRA PRADESH
PRIYA M
India |
| Phone |
09990624306 |
| Fax |
|
| Email |
winpriya6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYA M |
| Designation |
NURSING TUTOR |
| Affiliation |
AIIMS, MANGALAGIRI |
| Address |
108,college of Nursing, AIIMS, MANGALAGIRI, GUNTUR DISTRICT,ANDHRAPRADESH,
Guntur
ANDHRA PRADESH
PRIYA M
India |
| Phone |
09990624306 |
| Fax |
|
| Email |
winpriya6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support given by AIIMS, Mangalagiri, Guntur District, Andhrapradesh, 522503 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [self] |
|
|
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 |
| PRIYA M |
AIIMS, MANGALAGIRI |
301, OBG OPD, THIRD FLOOR, AIIMS, MANGALAGIRI
Guntur
ANDHRA PRADESH |
09990624306
winpriya6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family planning counselling |
family planning counselling given to the eligible couple. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1.willingness to participate and provide informed consent
2. Ability to understand the language of Telugu, HIndi or English
|
|
| ExclusionCriteria |
| Details |
1. Women who are currently pregnant in first and second trimester
2.woment with contraindication of family planning methods
3. Women who have received intensive family planning counselling in the past six months
4.woemn with severe mental or physical disabilities that hinders understanding of couselling session |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge,attitude and Adoption rate of family plannign methods of eligible couple |
baseline and after 6 weeks assessment of knowledge, attitude and adoption rate of family planning method |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
24/03/2025 |
| 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="0"
Months="6"
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
|
This study aims to assess the effectiveness of
nurse-directed family planning counseling on the knowledge, attitudes, and
conversion rates of family planning methods adoption among Eligible couple attendign the
OBG OPD at a selected tertiary care center in South India. Nurses will undergo
family planning proficiency training to
enhance their counseling skills, followed by conducting tailored
counseling sessions with patients. The study will evaluate changes in knowledge
and attitudes, as well as the
acceptance of family planning methods. By integrating innovative
training techniques, this research seeks to provide valuable insights into
improving family planning services and outcomes in the region.
|