NCT04752787

Brief Summary

Breast milk is a unique, natural and universal food with excellent content that ensures healthy growth and development of the baby. Since twin babies are mostly born prematurely, with low birth weight and with health problems affecting important systems such as respiratory and gastrointestinal systems, breastfeeding becomes more important. Studies show that mothers with twin babies can produce sufficient quantity and quality of milk. However, the breastfeeding rates of twin babies are not at the desired level. In the successful breastfeeding of twin babies, breastfeeding education started before birth has an important place in initiating and maintaining successful breastfeeding. Today, it is recommended to use different materials and techniques in order to ensure continuity in the training given to healthy and sick individuals. One of them is QR code supported training. Using different training and method techniques will make it easier for nurses to be more effective. The aim of this study is to examine the effect of QR code supported online breastfeeding education given to pregnant women expecting twins on breastfeeding intention and feeding with breast milk in the first six months. Research Hypotheses: H0: There is no difference between breastfeeding intention and success of mothers who have twin babies who are given online breastfeeding training and those who are not. H1: The breastfeeding intention and success of mothers with twin babies who are given online breastfeeding training with QR code is higher than mothers who are given online breastfeeding training only. H1: The breastfeeding intention and success of mothers with twin babies who are given online breastfeeding training with QR code is higher than mothers who are not given breastfeeding training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

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

January 26, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 26, 2021

Last Update Submit

February 12, 2021

Conditions

Keywords

Twin BabyTwin PregnancyQuick Response CodeBreastfeeding TrainingBreastfeeding Intention

Outcome Measures

Primary Outcomes (1)

  • Evaluation of breastfeeding intention in study and control groups

    Breastfeeding Intention Scale for Pregnant Expecting Twin Babies" developed to evaluate the intention of breastfeeding in pregnant women expecting twin babies, each item is scored from 1 to 5 on a 5-point Likert-type scale consisting of 7 positive items and the scores vary according to the responses of the items. Scoring items; Strongly Disagree (1), Disagree (2), Moderately Agree (3), Agree (4), Strongly Agree (5). The minimum score that can be obtained from the scale is 7 and the maximum score is 35. The high total score obtained from the scale indicates that pregnant women expecting twin babies have a high breastfeeding intention.

    Change from pre-education and two weeks after education breastfeeding intention

Secondary Outcomes (2)

  • Breastfeeding rates in study and control groups

    Within the first week following the birth of pregnant women, every month starting from the 1st month until the 6th month

  • Exclusively breastfeeding rates in study and control groups

    Within the first week following the birth of pregnant women, every month starting from the 1st month until the 6th month

Study Arms (3)

Experimental

EXPERIMENTAL

Experimental group 1: Breastfeeding training for successful breastfeeding in twin babies will be given to the online training group. The training will be carried out by the researchers (DM) and (SYC) using visual training tools (power point presentation, simultaneous breastfeeding animations in twin babies and breastfeeding guide). Due to the Covid-19 pandemic process, it will be carried out online and remotely. Training on successful breastfeeding in twin babies will be carried out in two sessions at a time. In the first session, about 45 minutes of online slide-assisted training on successful breastfeeding in twin babies and the importance of breast milk will be conducted and questions of pregnant women will be answered. Total training will take approximately one and a half hours.

Other: Online breastfeeding training

Active comparator

ACTIVE COMPARATOR

Experimental group 2: Breastfeeding training for successful breastfeeding in twin babies will be given to the QR supported online training group. Due to the Covid-19 pandemic process, it will be carried out online and remotely. Training on successful breastfeeding in twin babies will be carried out in two sessions at a time. Total training will take approximately one and a half hours. In the guideline, there will be 4 vieos ralted to "Breastfeeding and Feeding with Breast Milk in Twin Babies", "Breastfeeding Techniques and Positions in Twin Babies", "Expressing Breastfeeding, Storing and Feeding it to Babies" and "Problems Encountered in Breastfeeding and its Solutions", and simultaneous breastfeeding used in breastfeeding twin babies and also there will be a total of 7 QR codes, 3 of which are related to the animations (Animation 1-2-3) of the positions (double cradle grip, double football grip, combination of armpit and cradle grip-parallel grip).

Other: QR code supported online breastfeeding training

Control Groups

NO INTERVENTION

Pregnant women in the control group will be followed up in line with the routine health monitoring and information of the hospital.

Interventions

Online breastfeeding training will be provided to pregnant women expecting twin babies.

Experimental

QR code supported online breastfeeding training will be given to pregnant women who are expecting twin babies.

Active comparator

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsmothers
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Twin pregnant women who come to the pregnancy outpatient clinic
  • Having twin babies after birth,
  • Whose are least literate,
  • Pregnant women who can speak and understand Turkish well
  • Whose are 19 years of age or older,
  • Volunteering to participate in research,
  • Whose are between 28 -34th weeks of gestation,
  • Whose been Primigravida and her pregnancy twin
  • Do not have a diagnosed neurological, psychiatric or chronic disease (diabetes, chronic kidney failure, etc.) that will affect breastfeeding.
  • No health problems in mother and babies before or after birth
  • Risky drug use that passes through breast milk after birth
  • Pregnant women who have a smart phone, computer, tablet and wireless internet will be included in the study.

You may not qualify if:

  • Whose are 18 years of age or under Whose been multigravida and / or multiparous Whose have any health problems in the mother and babies before or after birth Whose do not have a smart phone, computer, tablet or wireless internet during the study period Participants who complete the questionnaire forms as missing will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

Related Publications (23)

  • Güler, E., & Eby, G. (2015). Akıllı ekranlarda mobil sağlık uygulamaları. Eğitim ve Öğretim Araştırmaları Dergisi, 4(3), 45-51.

    BACKGROUND
  • Al Saleh, S., & Bhat, S. A. (2015). Mobile learning: A systematic review. International Journal of Computer Applications, 114(11), 1-5.

    BACKGROUND
  • Samples, C., Ni, Z., & Shaw, R. J. (2014). Nursing and mHealth. International Journal of Nursing Sciences, 1(4), 330-333. https://doi.org/10.1016/j.ijnss.2014.08.002

    BACKGROUND
  • Aktaş, C., & Çaycı, B. (2013). QR kodun mobil eğitimde yeni eğitim yöntemlerinin geliştirilmesine katkısı. Global Media Journal, 119, 1-5.

    BACKGROUND
  • Hau, G. B., Siraj, S., Alias, N., Rauf, R. A. A., & Zakaria, A. (2013). Research and trends in the field of technology-enhanced learning from 2006 to 2011: A content analysis of Quick Response Code (QR-Code) and ıts application in selected studies. Malaysian Online Journal of Educational Technology, 1(1), 54-72. Retrieved from https://files.eric.ed.gov/fulltext/EJ1086361.pdf

    BACKGROUND
  • Overdijkink SB, Velu AV, Rosman AN, van Beukering MD, Kok M, Steegers-Theunissen RP. The Usability and Effectiveness of Mobile Health Technology-Based Lifestyle and Medical Intervention Apps Supporting Health Care During Pregnancy: Systematic Review. JMIR Mhealth Uhealth. 2018 Apr 24;6(4):e109. doi: 10.2196/mhealth.8834.

    PMID: 29691216BACKGROUND
  • Yayla M, Baytur Y. (2008). Multicentric multiple pregnancy study I - Epidemiology. Prenatal Journal, 16 (1): 1-8.

    BACKGROUND
  • Türkiye Neonataloji Derneği Yardımlı Üreme Teknikleri ve Çoğul Gebelikler Çalışma Grubu (2010). Yardımlı Üreme tekniklerinin neonatal mortalite ve morbidite üzerine etkileri. Çocuk Sağlığı ve Hastalıkları Dergisi, 53: 258-266.

    BACKGROUND
  • Sezer SD, Kucuk M, Yuksel H, Odabasi AR, Turkmen M, Cakmak BC, Doger FK. Perinatal and neonatal outcomes of twin pregnancies in Turkey. Twin Res Hum Genet. 2011 Apr;14(2):201-12. doi: 10.1375/twin.14.2.201.

    PMID: 21425905BACKGROUND
  • Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.

    PMID: 28135188BACKGROUND
  • Saint L, Maggiore P, Hartmann PE. Yield and nutrient content of milk in eight women breast-feeding twins and one woman breast-feeding triplets. Br J Nutr. 1986 Jul;56(1):49-58. doi: 10.1079/bjn19860084.

    PMID: 3676208BACKGROUND
  • Ooki S. Breast-feeding rates and related maternal and infants' obstetric factors in Japanese twins. Environ Health Prev Med. 2008 Jul;13(4):187-97. doi: 10.1007/s12199-008-0028-y. Epub 2008 Apr 22.

    PMID: 19568905BACKGROUND
  • Ostlund A, Nordstrom M, Dykes F, Flacking R. Breastfeeding in preterm and term twins--maternal factors associated with early cessation: a population-based study. J Hum Lact. 2010 Aug;26(3):235-41; quiz 327-9. doi: 10.1177/0890334409359627. Epub 2010 Feb 5.

    PMID: 20139377BACKGROUND
  • Whitford HM, Wallis SK, Dowswell T, West HM, Renfrew MJ. Breastfeeding education and support for women with twins or higher order multiples. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD012003. doi: 10.1002/14651858.CD012003.pub2.

    PMID: 28244065BACKGROUND
  • Basu S, Aundhakar CD, Galgali A. (2014). Gender discrimination in relation to exclusive breast feeding practices amongst twins in Rural India. International Journal of Health Sciences & Research, 4 (5): 139-43.

    BACKGROUND
  • Cinar N, Kose D, Alvur M, Dogu O. Mothers' Attitudes Toward Feeding Twin Babies in the First Six Months of Life: A Sample From Sakarya, Turkey. Iran J Pediatr. 2016 Jun 14;26(5):e5413. doi: 10.5812/ijp.5413. eCollection 2016 Oct.

    PMID: 28203331BACKGROUND
  • Damato EG, Dowling DA, Madigan EA, Thanattherakul C. Duration of breastfeeding for mothers of twins. J Obstet Gynecol Neonatal Nurs. 2005 Mar-Apr;34(2):201-9. doi: 10.1177/0884217504273671.

    PMID: 15781597BACKGROUND
  • Bennington LK. (2011). Breastfeeding multiples: It can be done. Newborn Infant Nurs Rev, 11: 194-197.

    BACKGROUND
  • Langkamp DL, Girardet RG. Primary care for twins and higher order multiples. Curr Probl Pediatr Adolesc Health Care. 2006 Feb;36(2):47-67. doi: 10.1016/j.cppeds.2005.10.005. No abstract available.

    PMID: 16414559BACKGROUND
  • Odei AB. (2013). Factors Assocıated with Exclusive Breastfeeding of Ghanaian Twins. The Unıversity of Ghana, Ghana, (Principal Supervisor: Prof Anna Lartey, Co-Supervisor: Dr. Gloria Ethel Otoo)

    BACKGROUND
  • Yenal K, Tokat MA, Ozan YD, Çeçe Ö, Abalın FB. (2013). Annelerin emzirme öz-yeterlilik algıları ile emzirme başarıları arasındaki ilişkinin incelenmesi. Hemşirelikte Eğitim ve Araştırma Dergisi, 10 (2): 14-19.

    BACKGROUND
  • Lumbiganon P, Martis R, Laopaiboon M, Festin MR, Ho JJ, Hakimi M. Antenatal breastfeeding education for increasing breastfeeding duration. Cochrane Database Syst Rev. 2016 Dec 6;12(12):CD006425. doi: 10.1002/14651858.CD006425.pub4.

    PMID: 27922724BACKGROUND
  • Shim JI, Kang SJ. Impact of Breastfeeding Knowledge, Attitude, and Barriers on Breastfeeding Practice among Twin Mothers. Korean J Women Health Nurs. 2017 Jun;23(2):89-98. doi: 10.4069/kjwhn.2017.23.2.89. Epub 2017 Jun 27.

    PMID: 37684888BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Dilek Menekşe, Ass.prof.

    Sakarya University

    STUDY DIRECTOR
  • Sinem Yalnızoğlu Çaka, Res. Asist. Dr.

    Sakarya University

    PRINCIPAL INVESTIGATOR
  • Nursan Çınar, Prof. Dr.

    Sakarya University

    PRINCIPAL INVESTIGATOR
  • Hilal Uslu Yuvacı, Assist. prof.

    Sakarya University

    PRINCIPAL INVESTIGATOR
  • Bilge Kapudere, Res. Asist. Dr.

    Sakarya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Menekşe, Assist. prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Since the education about twin babies breastfeeding will be given by the researchers, single-blind randomization will be provided. The statistician will also be made blind for the data analysis purpose
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 12, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations