UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048750
Receipt number R000055538
Scientific Title DESCRIPTIVE STUDY TO ASSESS THE KNOWLEDGE OF NURSING STUDNETS ON BREASTFEEDING
Date of disclosure of the study information 2022/09/15
Last modified on 2022/09/16 14:30:32

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Basic information

Public title

KNOWLEDGE OF NURSING STUDENTS ON BREASTFEEDING

Acronym

Breastfeeding

Scientific Title

DESCRIPTIVE STUDY TO ASSESS THE KNOWLEDGE OF NURSING STUDNETS ON BREASTFEEDING

Scientific Title:Acronym

KNOWLEDGE, BREASTFEEDING

Region

Asia(except Japan)


Condition

Condition

NO

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Assess the knowledge of the students on Breastfeeding

Basic objectives2

Others

Basic objectives -Others

Associate the level of knowledge and selected socio-demographic variables

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Level of Knowledge on Breastfeeding within 1 week

Key secondary outcomes

Association between Selected Socio-Demographic variables and Level of Knowledge


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

19 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

Nursing students interested to take part and available during data collection period

Key exclusion criteria

Nursing students not understand teh language of Hindi and English

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Dr
Middle name Vadivukkarasi
Last name P

Organization

Shri Vinoba Bhave College of Nursing,

Division name

Silvassa, DNH, India

Zip code

396230

Address

Shri Vinoba Bhave Civil Hospital, Silvassa

TEL

917046593297

Email

krishraghav2010@gmail.com


Public contact

Name of contact person

1st name Dr
Middle name vadivukkarasi
Last name P

Organization

SHRI VINOBA BHAVE COLLEGE OF NURSING, SILVASSA,DNH

Division name

Silvassa, DNH, India

Zip code

396230

Address

Shri Vinoba Bhave Civil Hospital, Silvassa, DNH

TEL

917046593297

Homepage URL

https://orcid.org/0000-0003-4084-5406

Email

krishraghav2010@gmail.com


Sponsor or person

Institute

Shri Vinoba Bhave College of Nursing, Silvassa, DNH

Department of OBG Nursing

Institute

Department

Personal name



Funding Source

Organization

Self

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shri Vinoba Bhave College of Nursing

Address

Shri Vinoba bhave Civil Hsopital, Silvassa

Tel

919998693183

Email

nirutandel@yahoo.co.in


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

SHRI VINOB ABHAVE COLLEGE OF NURSING (SILVASSA)


Other administrative information

Date of disclosure of the study information

2022 Year 09 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

108

Results

1. According to Socio-demographic variables:
Study finding shows that 81% of them were between 18 to 25 years and 19% of them were between 26-45 years of old. Most of the study participants (75.7%) were female and (24.3%) of them were male. As per the educational qualifications 42.98%, 41.12%, 8.02% and 7.88% of them were B.Sc.N, M.Sc.N, P.B.B.Sc.N and DGNM accordingly.

Results date posted

2022 Year 09 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

1. Age
2. Gender
3. Educational Qualification

Participant flow

Google form on Structured Knowledge questionnaire was prepared and shared to the nursing students

Adverse events

Not applicable

Outcome measures

Knowledge on Breastfeeding
1. Level of Knowledge on Breastfeeding:
Most of the Nursing Students (48%) had good knowledge (11-15 score), 24% of them had poor knowledge (6-10 score), 22% of them had excellent knowledge (16-20 score) and 6% of them had very poor knowledge (0-5%).

2. Association between Level of knowledge and Socio-Demographic variables
There is no association of Age, Gender with variables except Educational Qualification

Plan to share IPD

Yes

IPD sharing Plan description

1. Research Methodology
2. Structured Knowledge Questionnaire on Breastfeeding
3. Master coding sheet of Tool


Progress

Recruitment status

Completed

Date of protocol fixation

2022 Year 07 Month 15 Day

Date of IRB

2022 Year 07 Month 31 Day

Anticipated trial start date

2022 Year 08 Month 01 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry

2022 Year 08 Month 31 Day

Date trial data considered complete

2022 Year 08 Month 31 Day

Date analysis concluded

2022 Year 09 Month 15 Day


Other

Other related information

Structured Questionnaire on Knowledge regarding Breastfeeding is prepared and administered through google forms.


Management information

Registered date

2022 Year 08 Month 24 Day

Last modified on

2022 Year 09 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055538


Research Plan
Registered date File name
2022/09/16 RESEARCH METHODOLOGY ON BREASTFEEDING STUDY.pdf

Research case data specifications
Registered date File name
2022/09/16 Structured knowldege questionnaire on breastfeeding.pdf

Research case data
Registered date File name
2022/09/16 master coding sheet of BFS.xlsx