Effectiveness of Breastfeeding Techniques to Improve Latching and Prevention of Nipplesoreness

Sponsor
University of Health Sciences Lahore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06108154
Collaborator
(none)
60
2
2

Study Details

Study Description

Brief Summary

There is a significance difference in latch and Nipplesoreness 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.RCT designed selected. Sample size 60 participants. Latch and nipplesoreness rating scale used for data collection.. spss used for data analysis.outcome utilised in clinical and educative health care system.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational breastfeeding traning session
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1 interventional.group and control group observation compare for final result.1 interventional.group and control group observation compare for final result.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effectiveness of Breastfeeding Techniques to Improve Latching and Prevention of Nipplesoreness Among Primipara Mothers
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Educational interventional Arm.

Interventional arm received educational supportive breastfeeding and hand on training session on Latch techniques according to UNICEF guideline.

Behavioral: Educational breastfeeding traning session
Educational breastfeeding training session base on dialogical, visual attractive and training session on Proper LATCH techniques and breastfeeding positions to prevent from nipplesoreness.
Other Names:
  • Breastfeeding hands on training session.
  • No Intervention: Control routine hospital care Arm.

    Control. No interventions receive hospital routine care

    Outcome Measures

    Primary Outcome Measures

    1. Demographical data, infant Latch on breast. [One month]

      Demographical data consisting of socio-demographic characteristics of participants 1: LATCH scoring system. A systematic breastfeeding assessment, diagnostic and evaluating tool for individual breastfeeding sessions. The tool assigns a numerical score, 0, 1, 2, and includes five key elements of breastfeeding.LATCH: 1. L for infant's ability to latch onto the breast, 2 .A for the presence of audible swallowing of the infant at the breast, 3.T for mother's nipple type, 4.C for mother's sense of comfort,5.H for holding.The total score range from 0 to 10; higher score, the more chances of successful effective breastfeeding. A LATCH score of 0-3 is regarded as poor, 4-7 as moderate/fair, and 8-10 as good/well, during early postpartum. The mothers observed for breastfeeding LATCH by 5-10 minute.

    Secondary Outcome Measures

    1. Nipplesoreness [One month]

      The nipple soreness rating scale used to determine the pain severity and fissure/cracks on nipples during breastfeeding, 0 = No pain, no tenderness, normal in colour (normal findings), 4 = severe pain, nipple cracked. (Nipple soreness score from 1 to 4 are considered incidence of nipple soreness).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • primiparous mothers in early postpartum with healthy infant outcomes.
    Exclusion Criteria:
    • Sick mothers.

    • Mother with anomaly infants.

    • Mothers with contraindication for breastfeeding.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Health Sciences Lahore

    Investigators

    • Principal Investigator: Shazia Taj, PG student

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shazia taj, Principal investigator, University of Health Sciences Lahore
    ClinicalTrials.gov Identifier:
    NCT06108154
    Other Study ID Numbers:
    • LATCH RCT 2007
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 30, 2023