NCT06443801

Brief Summary

Breastfeeding is the safest and healthiest method of feeding an infant and positively affects the health of both the mother and the baby in the short and long term. Breastfeeding self-efficacy refers to the mother's perceived ability and self-confidence to breastfeed her baby. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors. Today, web-based support programs are created thanks to advances in science and technology; It has advantages such as being cheap, easily accessible, not causing any harm when done under control, providing flexibility in the participant's use of time, and accessing the training content whenever needed. Due to the pandemic process, the investigators are in and with the effect of developing technology, training is provided for the needs of individuals by using many alternative education methods such as web-based education and distance education in the field of health, as in many areas. Studies have reported that web-based support programs increase the quality of life in individuals, are useful in symptom management, and are effective in raising awareness on the subjects intended to provide support and in gaining positive attitudes and behaviors. The study is planned to be carried out between 01.01.2023 and 31.07.2024 in the Family Health Centers affiliated with the Taşköprü District Health Directorate of Kastamonu. The study universe consists of 24-36 weeks pregnant women who come to the Family Health Centers of the Taşköprü District Health Directorate. The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria. Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP in the 3rd month, and PP in the 6th month. Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

June 5, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

October 2, 2023

Last Update Submit

May 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of postpartum women

    In the study, R v3.6.1 program was used for Power analysis, alpha error was 5%, beta error was 20%, it was predicted that between the variables as a result of the study process, and a minimum of 90 (45 case groups, 50 control group)

    6 month

Secondary Outcomes (4)

  • Evaluation of Infant Feeding Attitude

    Antenatal and postpartum 6th month

  • Evaluation of Depression Level

    Postpartum 7th day, 3rd month, and 6th month

  • Evaluation of Perception of Insufficient Milk

    Postpartum 7th day, 3rd month, and 6th month

  • Evaluation of Breastfeeding Self-Efficacy

    Postpartum 7th day, 3rd month, and 6th month

Study Arms (2)

THE GROUP THAT WILL NOT TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY

NO INTERVENTION

This group will not take web-based education.

THE GROUP THAT WİLL TAKE WEB-BASED BREASTFEEDİNG EDUCATION İN PREGNANT

EXPERIMENTAL

this group will take web-based education.

Other: THE GROUP THAT WILL TAKE WEB-BASED BREASTFEEDING EDUCATION IN PREGNANCY

Interventions

The data of the study will be applied to both groups at the same time. No training will be given to the control group, and web-based breastfeeding training consisting of 4 modules will be given to the experimental group during their pregnancy. As data collection tools; Pregnant data collection form, Postpartum information form, IOWA infant feeding attitude scale, IMDAT scale, Edinburgh depression scale, Breastfeeding motivation scale, Insufficient milk perception scale, Breastfeeding self-efficacy scale and System usability scale will be used. Data collection tools will be applied to women at pregnancy, postpartum 7th day, PP 3rd month and PP 6th month. Appropriate methods will be used in the evaluation of the data. The significance level will be determined as α=0.05. The sample of the study consisted of 90 primiparous pregnant women, 45 of whom were in the control and 45 in the experimental group, who met the inclusion criteria.

THE GROUP THAT WİLL TAKE WEB-BASED BREASTFEEDİNG EDUCATION İN PREGNANT

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale. Because this research is for pregnant.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study.
  • Being primiparous at 24-36 weeks of pregnancy.
  • To be able to speak and speak Turkish.
  • To be at least a primary school graduate.
  • Having a computer or smartphone at home and being able to use it.
  • No risk in pregnancy.
  • The woman does not have any chronic disease.

You may not qualify if:

  • The emergence of a risky situation during pregnancy.
  • Premature birth of the woman participating in the study.
  • Carrying out a risky birth and hospitalization of the mother or baby due to it.
  • Termination of pregnancy prematurely for any reason (such as infant death)
  • The fact that the pregnant women in the experimental group did not complete the training modules before birth.
  • The fact that the women participating in the study did not respond to the directed scales and questionnaires.
  • The woman's desire to quit working without giving any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (6)

  • Kleinpell R, Ely EW, Williams G, Liolios A, Ward N, Tisherman SA. Web-based resources for critical care education. Crit Care Med. 2011 Mar;39(3):541-53. doi: 10.1097/CCM.0b013e318206b5b5.

  • Maloney S, Haas R, Keating JL, Molloy E, Jolly B, Sims J, Morgan P, Haines T. Breakeven, cost benefit, cost effectiveness, and willingness to pay for web-based versus face-to-face education delivery for health professionals. J Med Internet Res. 2012 Apr 2;14(2):e47. doi: 10.2196/jmir.2040.

  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

  • Dennis CL, Faux S. Development and psychometric testing of the Breastfeeding Self-Efficacy Scale. Res Nurs Health. 1999 Oct;22(5):399-409. doi: 10.1002/(sici)1098-240x(199910)22:53.0.co;2-4.

  • Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

  • Velioglu E, Demirci N. The effect of web-based breastfeeding education given to primiparous pregnant women: a randomised controlled study. Afr J Reprod Health. 2024 Dec 31;28(12):61-72. doi: 10.29063/ajrh2024/v28i12.7.

Related Links

MeSH Terms

Interventions

Pregnancy

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Elif velioğlu, PhDc

    Marmara University

    PRINCIPAL INVESTIGATOR
  • Nurdan Demirci, Prof

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

October 2, 2023

First Posted

June 5, 2024

Study Start

May 15, 2024

Primary Completion

August 10, 2024

Study Completion

September 15, 2024

Last Updated

June 5, 2024

Record last verified: 2024-05

Locations