Clinical trial NCT06108154: Effectiveness of Breastfeeding Techniques to Improve Latching and Prevention of Nipplesoreness
Official title: Effectiveness of Breastfeeding Techniques to Improve Latching and Prevention of Nipple-soreness Among Primipara Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 SVD group divided into two sub groups. A) interventional.group and B)control group.2. LSCS group divided into two sub groups A)intervention, B)control group.

observation compare for final result.
Primary purpose: PREVENTION

Brief summary: There is a significance difference in latch and Nipple-soreness score after intervention in control and interventional. Study population is primiparous mothers.group.interventional group received Breastfeeding supportive educational and training session.control group received hospital routine care.Randomised control trial designed selected. Sample size 60 participants. Latch and nipplesoreness rating scale used for data collection. statistical package of social sciences used for data analysis.outcome utilised in clinical and educative health care system.

Detailed description: Breastfeeding is a natural physiological process but initial critical step on a child s path to a healthy future. Breastfeeding is beneficial to mother, child and society. For this purpose WHO Re-established global breastfeeding culture to promote exclusive breastfeeding (EBF) up-to first 6 months of life 50% by year 2025.Globally Among primiparous 33% mothers experienced breastfeeding problems in first two weeks postpartum. Determinants of premature termination of EBF are nipple soreness, inadequate latch techniques, breast engorgement, and lack of educative supportive system on preventive measures. In Pakistan IMR rate is 55.77% in 2022, major cause is failure to initiate and continuity in breast feeding. Infants get EBF 48% limited to 3 month. One of the significant factor is sore nipples that preeminent by the poor latch contributing 72%, secondary to infants improper sucking. It is hypothesized that ensuring sustain breast feeding by implementing the Planned, educational supportive training sessions, close observation to identify latch related problems and correct them promptly to prevent from nipple soreness, and predict for EBF. The aim of study to determine effectiveness of educational and hand on practice breastfeeding training session to prevent breastfeeding problems that ensure successful breastfeeding journey. Rational of this study is objectively assess the breastfeeding status and take corrective measure before problem become complicated by giving educational breastfeeding training session on preventive basis. However least literature existed on such preventive basis training sessions in countries that have high IMR. The study design will be "Randomized Control Trial." Sample size will comprise of 60 Participants 30 in control and 30 in interventional. Study participants will be selected by non-probability purposive sampling design and allocated in control group and interventional group by Simple Random sampling technique. After signing the informed consent form by participants Demographical data will be elicited. Nipple soreness rating scale and LATCH scoring system will be used to assess the feeding status. Observations will be recorded. SPSS will be used for data analysis and results compare between groups. Independent sample t test will be used to compare the effects of post test score of educational breastfeeding training session. Repeated measure of ANOVA will be used to compare differences between interventional group and control group for weekly follow up if data is normally distributed. A p-value of \<0.05 will be considered statistically significant. Outcome utilization of this study, Participants may use independently breastfeeding skills and achieve sustain breastfeeding process. Health care Administrator may make a policy to implement LATCH charting system, (like APGAR score). LATCH scoring system may include in nursing and medical education. Limitations of this study may use limited sample size and lack of follow-ups of infant up-to 6 months. More studies may need to confirm the findings for long term benefits of such training session

Eligibility criteria: Inclusion Criteria:

* primiparous mothers in early postpartum with healthy infant outcomes.

Exclusion Criteria:

* Sick mothers.
* Mother with anomaly infants.
* Mothers with contraindication for breastfeeding.

Primary outcomes:
measure: Demographical data, infant Latch on breast.
timeFrame: One month
Secondary outcomes:
measure: Nipplesoreness
timeFrame: One month
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of health sciences lahore
state: Punjab
Study officials:
affiliation: PG student
name: Shazia Taj
role: PRINCIPAL_INVESTIGATOR
References: