| CTRI Number |
CTRI/2020/04/024467 [Registered on: 03/04/2020] Trial Registered Prospectively |
| Last Modified On: |
23/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Other (Specify) [Experimental] |
| Study Design |
Other |
|
Public Title of Study
|
prevention of sore nipple |
|
Scientific Title of Study
|
A study to assess the effectiveness of breast milk in the prevention of sore nipple among postnatal mothers admitted in selected hospitals hospitals of Ambala Haryana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadiya Rashid |
| Designation |
Post- Graduate Student |
| Affiliation |
M.M.College of nursing |
| Address |
M.M.College of Nursing, Mullana Ambala
M.M.College of Nursing, Mullana Ambala
Ambala
HARYANA
133207
India |
| Phone |
9350544749 |
| Fax |
|
| Email |
nadiyarashid37@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Sheoran |
| Designation |
Head of Department Obstetrics and Gynecology Nursing Department |
| Affiliation |
M.M.College of Nursing/ Maharishi Markandeshwar University |
| Address |
Room NO.24 First Floor Obstetrics and Gynecology Department, Maharishi Markandeshwar University,M.M.College of nursing Mullana Ambala
M.M.College of nursing, Mullana Ambala,Haryana
Ambala
HARYANA
133207
India |
| Phone |
9350544749 |
| Fax |
|
| Email |
poonamsheoran78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nadiya Rashid |
| Designation |
Post- Graduate Student |
| Affiliation |
M.M.College of nursing |
| Address |
M.M.College of Nursing Mullana Ambala
M.M.College of Nursing Mullana Ambala
Ambala
HARYANA
133203
India |
| Phone |
9350544749 |
| Fax |
|
| Email |
nadiyarashid37@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nadiya Rashid |
| Address |
M.M.College of nursing Mullana Ambala |
| Type of Sponsor |
Other [(self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nadiya Rashid |
M.M.College of nursing |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nadiya Rashid |
M.M Hospital Mullana Ambala Haryana |
first floor obstetrics and gynecology department near blood bank
Ambala
HARYANA |
9350544749
nadiyarashid37@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O36||Maternal care for other fetal problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
application of breast milk for prevention of sore nipple |
application of breast milk for prevention of sore nipple among postnatal mothers |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal mothers
Mothers who breast feed their babies
Duration of stay more than 3 days in hospital |
|
| ExclusionCriteria |
| Details |
Who are having breast pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| breast milk will be applied due to which sore nipple will be prevented among postnatal mothers |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| prevention of sore nipple |
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/04/2020 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A
study to assess the effectiveness of breast
milk in the prevention of sore nipple among postnatal mothers admitted in
selected hospital
of
Ambala Haryana objectives: 1.To assess and compare occurrence of sore
nipple among postnatal mothers in experimental and comparison group.
2. To find out the association of sore nipple
score with selected demographic variables. hypothesis: Following
hypothesis will be tested at 0.05 level of significance: hH1:
There will be significant difference in mean post-test nipple
soreness score among postnatal mothers after application
of breast milk in experimental and comparison group. H2:
There will be significant association of occurrence of nipple
soreness score among postnatal mothers with their
selected demographic variables INCLUSION
CRITERIA:
• Willing
to participate in the study.
• Breast
feeding their babies.
• Available
at the time of study.
Exclusion
criteria:
• Having
other breast pathology.(Breast infection, carcinoma, mastitis, bloody
discharge etc.)
|