NCT06256822

Brief Summary

Aim: The aim of this study was to determine the effect of breastfeeding training given with virtual reality (VR) to postpartum primiparous mothers on breastfeeding success and breastfeeding self-efficacy. Method: The research was designed as a prospective randomized controlled study. In total, 66 women were included in the study, with 31 in the control group and 35 in the intervention group. The intervention group watched a breastfeeding video with VR in the 4th and 24th hours after cesarean. Research data were collected with the sociodemographic information form, LATCH Breastfeeding Charting System and Documentation Tool and the Breastfeeding Self-Efficacy Scale. The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

January 21, 2024

Last Update Submit

February 12, 2024

Conditions

Keywords

breastfeeding successcesareaneducation technologybreastfeeding self-efficacyvirtual reality

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Diagnostic and Assessment Scale

    The Latch Breastfeeding Scale was developed by Jensen and Wallace (1993) to objectively diagnose breastfeeding, detect breastfeeding problems, plan breastfeeding education, and create the same language for health professionals. The Cronbach's alpha coefficient of the scale was found to be 0.93. The scale, adapted into Turkish by Yenal and Okumuş (2003), consists of five evaluation steps. LATCH stands for the English expressions of these steps. These evaluation steps are: ''L= Latch on breast'', ''A= Observation of the baby's swallowing movement (Audibleswallowing)'', ''T= Type of nipple'', ''C = The mother's comfort regarding the breast and nipple (Comfort breast/nipple)'', ''H = Holding position of the baby (Hold)''. Items on the scale are scored as 0-1-2. The highest score that can be obtained from the scale is 10 and the lowest score is 0. The Cronbach's alpha coefficient of the scale was found to be 0.95.

    6 months

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbreastfeeding mother
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

mothers who gave birth with cesarean section

You may qualify if:

  • The study included mothers who gave birth with cesarean section, received breastfeeding counseling during pregnancy, with no vision or hearing disabilities and without any neurological disorder.

You may not qualify if:

  • Mothers who did not give birth by cesarean section, did not receive breastfeeding counseling during pregnancy, had visual or hearing impairment, or had any neurological disease were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Samsun, 55080, Turkey (Türkiye)

Location

Related Publications (1)

  • Kilic U, Arar M, Oruc MA. The effect of virtual reality on the breastfeeding process: a randomized controlled study. J Perinatol. 2024 Nov;44(11):1611-1616. doi: 10.1038/s41372-024-02077-0. Epub 2024 Jul 31.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 21, 2024

First Posted

February 13, 2024

Study Start

January 1, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations