NCT05902481

Brief Summary

Breast-feeding; It is the basic step of newborn, maternal and community health. Breastfeeding counseling, which is planned to encourage, initiate and continue breastfeeding in line with the recommendations of the World Health Organization, is extremely important in order to achieve the Sustainable Development Goals. Breastfeeding counseling with mixed reality technology will contribute to the literature. The research will be carried out between January 2023 and December 2024 in the hospitals in Mersin with a delivery room. The universe will consist of all pregnant women who come to the obstetrics clinics of the specified hospitals for follow-up purposes. G Power 3.1 program was used for sampling. By using the G Power 3.1 program in the sample calculation (30); According to the Cohen Guidelines (Cohen's d); effect size was 0.5, power was 0.80, and significance level was 0.05. It was calculated as 102 people, with at least 51 people in the intervention group and at least 51 people in the control group. The sample number was determined as 112 pregnant women to receive 10% (5 each) for the intervention and control groups in case the participants dropped out of the study. In the study, "Block Randomization" method, which is one of the fixed probability randomization methods, will be used in order to ensure homogeneity between the groups and to eliminate selection bias. In the intervention group; Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test to pregnant women in their 3rd trimester and breastfeeding counseling based on mixed reality technology will be given. The LATCH Breastfeeding Diagnosis and Evaluation Scale and Postpartum Breastfeeding Self-Efficacy Scale will be filled in within 24 hours and on the 7th day after giving birth. The same steps will be performed for the pregnant women in the control group, and unlike the intervention group, counseling will be applied with Power Point technique instead of mixed reality technology. Statistical analyzes will be made using a package program called SPSS (IBM SPSS Statistics 24). In descriptive statistical analysis, mean, standard deviation, median, frequency, percentile, minimum and maximum values will be calculated. Descriptive, parametric and nonparametric statistical analysis methods will be used in the analysis of the data. Various studies have been conducted in Turkey using different methods on breastfeeding counseling, but no study has been found in which breastfeeding counseling was provided with mixed reality technology. Therefore, a randomized controlled experimental type study will be conducted to evaluate the effect of mixed reality technology-based breastfeeding counseling on breastfeeding success and self-efficacy of women.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

June 5, 2023

Last Update Submit

June 5, 2023

Conditions

Keywords

Breast milkBreastfeedingBreastfeeding counselingAntenatal periodMixed reality technology

Outcome Measures

Primary Outcomes (4)

  • Antenatal Breastfeeding Self-Efficacy Scale

    Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.

    1 day

  • Postpartum Breastfeeding Self-Efficacy Scale

    Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.The difference of the antenatal form of the scale from the postnatal form is the use of the phrase "future tense" in the scale items.

    1 day

  • LATCH Breastfeeding Diagnosis and Evaluation Scale

    The LATCH Breastfeeding Diagnostic and Evaluation Scale was developed by Jensen et al. in 1994 (36). The Turkish validity and reliability of the scale were performed by Demirhan and Pek in 1997, Koyun in 2001, and Yenal and Okumuş in 2003 (37,38). The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation.

    1 day

  • Postpartum Breastfeeding Self-Efficacy Scale

    It was developed by the researcher in line with the literature in order to determine the characteristics of infants and breastfeeding in the postnatal period. In the form, data related to the birth process such as the week of gestation, the mode of delivery and the situation of experiencing problems during delivery; There are 11 questions questioning the breastfeeding experience, such as the baby's gender, height and weight, the time of first breastfeeding, problems during breastfeeding, and the first food given to the baby.

    1 day

Study Arms (2)

Intervention Group

EXPERIMENTAL

Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women who are between the 6th and 7th weeks of age. After the pre-test is applied, pregnant women will be given breastfeeding counseling based on mixed reality technology.

Other: Education

Control Group

NO INTERVENTION

Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women in the third trimester who agreed to participate in our study and met the inclusion criteria. After the pre-test is applied, standard breastfeeding counseling will be given to pregnant women with Power Point technique.

Interventions

education about breastfeeding with mixed reality technology.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Continuing pregnancy between gestational weeks,
  • Primigravida,
  • Those who have not received a planned breastfeeding training before,
  • Pregnant women who agree to participate in the study will be included.

You may not qualify if:

  • Having a risky pregnancy,
  • Postpartum mother and/or baby have a health condition that prevents breastfeeding,
  • Having multiple pregnancy,
  • The mother and/or baby hospitalized for the first 7 days,
  • Can't speak or understand Turkish,
  • Women with intellectual disability and serious mental disorders will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • World Alliance for Breastfeeding Action (WABA). Messages for World Health Day 2022 - Breastfeeding Is A Climate-smart Decision. https://waba.org.my/ . Erişim Tarihi: 12.10.2022

    BACKGROUND
  • Chowdhury R, Sinha B, Sankar MJ, Taneja S, Bhandari N, Rollins N, Bahl R, Martines J. Breastfeeding and maternal health outcomes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):96-113. doi: 10.1111/apa.13102.

    PMID: 26172878BACKGROUND
  • Krol KM, Grossmann T. Psychological effects of breastfeeding on children and mothers. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Aug;61(8):977-985. doi: 10.1007/s00103-018-2769-0.

    PMID: 29934681BACKGROUND
  • Tewabe T. Prelacteal Feeding Practices among Mothers in Motta Town, Northwest Ethiopia: A Cross-sectional Study. Ethiop J Health Sci. 2018 Jul;28(4):393-402. doi: 10.4314/ejhs.v28i4.5.

    PMID: 30607052BACKGROUND
  • Rozga MR, Kerver JM, Olson BH. Self-reported reasons for breastfeeding cessation among low-income women enrolled in a peer counseling breastfeeding support program. J Hum Lact. 2015 Feb;31(1):129-37; quiz 189-90. doi: 10.1177/0890334414548070. Epub 2014 Aug 26.

    PMID: 25158829BACKGROUND
  • Martin-Iglesias S, Santamaria-Martin MJ, Alonso-Alvarez A, Rico-Blazquez M, Del Cura-Gonzalez I, Rodriguez-Barrientosn R, Barbera-Martin A, Sanz-Cuesta T, Isabel Coghen-Vigueras M, de Antonio-Ramirez I, Durand-Rincon I, Garrido-Rodriguez F, Geijo-Rincon MJ, Mielgo-Salvador R, Morales-Montalva MS, Reviriego-Gutierrez MA, Rivero-Garrido C, Ruiz-Calabria M, Santamaria-Mechano MP, Santiago-Fernandez R, Sillero-Quintana MI, Soto-Almendro B, Terol-Claramonte M, Villa-Arranz M. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy Childbirth. 2018 Feb 26;18(1):59. doi: 10.1186/s12884-018-1679-3.

    PMID: 29482516BACKGROUND
  • Alakaam A. Demand for Lactation Leads to Flowing Supply of Success: Support Requested from States to Improve Breastfeeding Practices. J Midwifery Womens Health. 2019 Nov;64(6):699-702. doi: 10.1111/jmwh.12977. Epub 2019 Jul 9. No abstract available.

    PMID: 31287205BACKGROUND
  • Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.

    PMID: 27654119BACKGROUND
  • Khorshidifard M, Amini M, Dehghani Mr, Zaree N, Pishva N & Zarifsanaiey N. Assessment of breastfeeding education by face to face and small-group education methods in mothers' self-efficacy in Kazeroun Health Centers in 2015. Women's Health Bulletin, 2017, 4(3):2-6.

    BACKGROUND

MeSH Terms

Conditions

Breast FeedingBreast Milk Expression

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Meltem Akbaş

    Cukurova University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: In the study, "Block Randomization" method, which is one of the fixed probability randomization methods, will be used in order to ensure homogeneity between the groups and to eliminate selection bias. Pregnant women who meet the criteria for inclusion in the study according to block randomization will be homogeneously distributed to each training group according to their gestational week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 15, 2023

Study Start

August 1, 2023

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share