| CTRI Number |
CTRI/2022/07/044374 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of ergonomic breastfeeding on the risk of musculoskeletal disorders in lactating mothers and the latch quality of their newborns. |
|
Scientific Title of Study
|
Influence of ergonomic breastfeeding on risk of developing musculoskeletal disorder in lactating mothers and quality of infants latch. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Prayag |
| Designation |
Post Graduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13, Physiotherapy Department
Community based rehabilitation
SDM College of Medical Sciences and Hospital
Manjushree Nagar
Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
9986333845 |
| Fax |
|
| Email |
prayagaditi223@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salima Bijapuri |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13, Physiotherapy Department
Community based rehabilitation
SDM College of Medical Sciences and Hospital
Manjushree Nagar
Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
7760580737 |
| Fax |
|
| Email |
drsalimamulla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Salima Bijapuri |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13, Physiotherapy Department
Community based rehabilitation
SDM College of Medical Sciences and Hospital
Manjushree Nagar
Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
7760580737 |
| Fax |
|
| Email |
drsalimamulla@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Physiotherapy
Manjushree Nagar
Sattur
Dharwad |
|
|
Primary Sponsor
|
| Name |
Aditi Prayag |
| Address |
OPD number 13, Physiotherapy Department
Community based rehabilitation
SDM College of Medical Sciences and Hospital
Manjushree Nagar
Sattur |
| 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 |
| Aditi Prayag |
SDM College of Medical Sciences and Hospital |
OPD Number 13
CBR Physiotherapy Department
SDM College of Medical Sciences and Hospital
Manjushree Nagar
Sattur
Dharwad
KARNATAKA |
9986333845
prayagaditi223@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Dental Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O927||Other and unspecified disorders oflactation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ergonomic Breastfeeding Posture |
Participants will be educated on proper breastfeeding posture on the day of recruitment and will be advised to follow the same during each breastfeeding session till the day of discharge i.e., day 3-5 |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
For mothers-
â–ª Maternal age > 18 years
â–ª Primigravida, Primiparous, Multiparous mothers without prior knowledge of
breastfeeding techniques
â–ª Able to understand the instructions
â–ª Mothers willing to continue breastfeeding
â–ª Consent to participate in the study
â–ª RULA score minimum 3
For newborn-
â–ª Normal birth weight newborn |
|
| ExclusionCriteria |
| Details |
For mothers-
â–ª History of breast cancer/ breast surgery
â–ª Twin pregnancy
â–ª Use of medication by mothers that affect breastfeeding/ contraindicated for breastfeeding
such as Sedating psychotherapeutic drugs, Anti-epileptic drugs and opioids causing side
effects such as drowsiness and respiratory depression.
â–ª Radioactive iodine 11 (to reduce risk of exposure to radiation)
â–ª Excessive use of topical iodine (especially on open wounds or mucous
membranes)
â–ª Cytotoxic chemotherapy
â–ª Health conditions such as Severe illness such as Sepsis and Herpes simplex virus type 1 (HSV-1)
For infants-
â–ª Baby in NICU
â–ª Health conditions such as
classic galactosemia, maple syrup urine disease,
phenylketonuria, very low birth weight babies (less than 1500 g), less than 32 weeks of gestational age, at risk for hypoglycemia (due to impaired metabolic adaptation, increased
glucose demand, infants who have experienced significant intrapartum
hypoxic/ischemic stress, illness, diabetic mothers, if blood sugar fails to
respond to optimal breastfeeding), congenital defects such as down syndrome, cleft palate/ lip, congenital heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rapid Upper Limb Assessment (RULA) |
Day 1 of recruitment and on the day of discharge i.e., Day 3-5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHO B-R-E-A-S-T feed observation form Grading system for Infants mouth attachment and effective suckling during breastfeeding |
Day 1 of recruitment and on the day of discharge i.e., Day3-5 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
30/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Breastmilk has long been recognized as the best type of nutrition for all mammals, as well as every infant’s and child’s right to good nutrition. Breastfeeding is good for both the mother and the baby. Despite all of the recognized benefits, India’s breastfeeding rate is just 55%, owing to stated barriers such as a lack of awareness, education, and accurate information among women about breastfeeding, as well as improper breastfeeding technique resulting to uncomfortable feeding posture As a result, there is a strong need to reduce the risk of developing musculoskeletal disorder as a result of incorrect breastfeeding position, which leads to an improper latch and hence difficulty establishing exclusive breastfeeding. Thus, the goal of this study is to provide early ergonomics training on breastfeeding and to identify good latch in the early postnatal period, which may have an impact on the health of the mother and infant by reducing the risk of musculoskeletal disorders and enhancing a relaxed and comfortable position for the mother to continue breastfeeding, as well as aiding India in achieving its exclusive breastfeeding goal. |