NCT06697769

Brief Summary

In this study, it was aimed to investigate the effect of breastfeeding experience on breastfeeding self-efficacy and motivation in women with virtual reality simulation. The main question it aims to answer is: Is breastfeeding experience with virtual reality glasses effective in increasing breastfeeding self-efficacy and motivation? They completed the Socio-Demographic and Pregnancy Information Form and the Prenatal Breastfeeding Self-efficacy Scale. Standard breastfeeding training was given. The application group also experienced breastfeeding with a virtual reality simulation. At the end of the application, they filled out the Prenatal Breastfeeding Self-efficacy Scale again. They completed the postpartum Primiparous Breastfeeding Motivation Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

November 13, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

breastfeedingvirtual realitypregnant women

Outcome Measures

Primary Outcomes (1)

  • Prenatal Breastfeeding Self-Efficacy Scale

    The Prenatal Breastfeeding Self-Efficacy Scale was developed by Wells and colleagues in 2006. The validity and reliability study of the scale in Turkish was conducted by Aydın and Pasinlioğlu in 2018. The scale consists of 20 items and is 5-point likert type. The lowest score to be taken from the scale is 20 and the highest score is 100. An increase in the score obtained from the scale indicates an increase in the perception of breastfeeding self-efficacy. The Cronbach Alpha value of the scale is 0.85.

    The breastfeeding experience with virtual reality glasses lasted 5 minutes. The intervention was repeated a second time a week later over a 5-minute period. After two weeks of intervention, the last Breastfeeding Self-efficacy Scale test was applied.

Secondary Outcomes (1)

  • Primipar Breastfeeding Motivation Scale

    The scale was completed up to two months after delivery.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Individual standard breastfeeding education was provided. After the training, they experienced the first breastfeeding simulation in a hospital environment for 5 minutes with virtual reality glasses. A week later (37. during the gestational week), they experienced the second breastfeeding simulation in a home environment for 5 minutes with virtual reality glasses. They completed the Prenatal Breastfeeding Self-efficacy Scale (final test). Finally, 1 after giving birth. and 2. they completed the Primiparous Breastfeeding Motivation Scale between months. Opinions were obtained from pregnant women who wanted to express their opinions about the virtual reality glasses breastfeeding simulation experiences.

Other: virtual reality

Control

NO INTERVENTION

Before starting the study, pregnant women who will be included in the control group according to the inclusion criteria and randomization were informed by the researcher about the study. At the beginning of the study, the control group (36. during the week of pregnancy) pregnant women filled out the Socio-Demographic and Pregnancy Information Form, Prenatal Breastfeeding Self-efficacy Scale (pre-test). Then, individual standard breastfeeding training was given. A week later (37. during the week of pregnancy), they completed the Prenatal Breastfeeding Self-efficacy Scale (final test). Finally, 1 after giving birth. and 2. they completed the Primiparous Breastfeeding Motivation Scale between months.

Interventions

breastfeeding simulation with virtual reality glasses

Virtual Reality

Eligibility Criteria

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

You may qualify if:

  • Pregnant women aged 18 and over,
  • Which is the primiparous,
  • \. during the week of pregnancy,
  • Women whose pregnancy is not in the risky group,
  • The person who knows how to read and write,
  • Without visual and auditory disabilities,
  • There is no breastfeeding barrier,
  • Pregnant women who have experienced virtual reality breastfeeding experience and filled out the survey forms completely have been included in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Orhangazi Family Health Center

Eskişehir, Turkey (Türkiye)

Location

Related Publications (1)

  • Tang K, Gerling K, Chen W, Geurts L. Information and Communication Systems to Tackle Barriers to Breastfeeding: Systematic Search and Review. J Med Internet Res. 2019 Sep 27;21(9):e13947. doi: 10.2196/13947.

    PMID: 31573903BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Ebru ERTAŞ

    ebru.ertas@ksbu.edu.tr

    STUDY CHAIR
  • Feride ÇEVİK

    feride.cevik@ksbu.edu.tr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized study with a control and intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 20, 2024

Study Start

January 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations