NCT06229574

Brief Summary

The breastfeeding software developed with the primiparous study was transferred to virtual reality glasses. This study will be applied to pregnant women and its effect on breastfeeding success and breastfeeding self-efficacy will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

December 21, 2023

Last Update Submit

February 18, 2025

Conditions

Keywords

Breast MilkBreast-feedingBreastfeeding EducationVirtual Reality

Outcome Measures

Primary Outcomes (2)

  • breastfeeding success

    LACTH BREASTFEEDING ASSESSMENT SCALE This measurement tool consists of five evaluation criteria and is a combination of the first letters of the English equivalents of these criteria. Each item is evaluated between 0 and 2 points. The total score that can be obtained from the measurement tool is 10. The measurement tool has no cutoff point. It is understood that the higher the LATCH score, the higher the breastfeeding success.

    4-5 week

  • breastfeeding self-efficacy

    breastfeeding self-efficacy scale The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short Form was conducted by Aluş Tokat and Okumuş in 2009 . This scale evaluates how competent mothers feel regarding breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of the options: Not at all sure , Very not sure , Sometimes sure , Sure and Very sure . 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.

    4-5 week

Study Arms (2)

intervention group

EXPERIMENTAL

The effect of breastfeeding education given with virtual reality glasses on breastfeeding success and breastfeeding self-efficacy will be evaluated. The education given during pregnancy will be evaluated on the first and seventh days after birth.

Other: virtual reality glasses

control group

NO INTERVENTION

Breastfeeding success and breastfeeding self-efficacy of women included in this group during pregnancy will be evaluated on the first and seventh days after birth.

Interventions

The breastfeeding software developed will be applied in this group.

intervention group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince it is a study on breastfeeding, it is a study specific to women.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 35
  • literate,
  • Pregnant women who are at 37 weeks of gestation and above,
  • Those with healthy pregnancies (singleton pregnancy, no systemic/chronic disease, etc.) -Primiparous pregnant women-
  • Vaginal birth planned,
  • planning to breastfeed,
  • Those who do not have any problems with their breasts that would make breastfeeding difficult (collapsed, missing tip, wound on the nipple, etc.),
  • Pregnant women who do not have vision, hearing or communication problems
  • Pregnant women who do not have any problems will be included in the study.

You may not qualify if:

  • Occurrence of a situation that prevents sucking
  • Baby with congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ipek Turhan

Kayseri, Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • ipek turhan, master

    Kayseri City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The application was administered to the participants by the researcher, but postpartum breastfeeding success and breastfeeding self-efficacy were evaluated by an interviewer who was unaware of the participants' group.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The research will be conducted as an experimental single-blind study with a randomized control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 29, 2024

Study Start

November 1, 2023

Primary Completion

May 1, 2024

Study Completion

January 1, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations