- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07768527
Virtual Reality and Simulation-Based Breastfeeding Training
August 12, 2026 updated by: Elif DAĞLI, Cukurova University
The Effect of Virtual Reality and Simulation-Based Breastfeeding Education on Breastfeeding Efficacy, Success, and Maintenance of Breastfeeding in Mothers Experiencing Breastfeeding Problems in the Postpartum Period: A Randomized Controlled Experimental Study
The aim of this study is to determine the effect of virtual reality and simulation-based breastfeeding education given to mothers experiencing breastfeeding problems in the postpartum period on breastfeeding potency, breastfeeding success, and breastfeeding continuation.
The research is a randomized controlled experimental study.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
The study population will consist of postpartum women who apply to the Lactation Counseling Clinic of the Obstetrics and Gynecology and Pediatric Hospital.
The sample will consist of women who voluntarily participate in the study.
Data will be collected through face-to-face interviews.
Data will be collected by completing the "Personal Information Form", the "Mother's Breastfeeding Ability Scale" and the "Bristol Breastfeeding Assessment Scale".
Study Type
Interventional
Enrollment (Estimated)
159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elif DAĞLI, Associate Professor
- Phone Number: 146 +903223386560
- Email: elifarik90@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Primiparous
- Infant in the neonatal period
- Over 18 years of age
- Term delivery
- Healthy baby and individual
- No communication barriers
- Willing to participate in the study
- Able to read and write Turkish
Exclusion Criteria:
- Multiparous
- Infant not in the neonatal period
- Under 18 years of age
- Premature delivery
- Unhealthy baby and individual
- No communication barriers
- Unwilling to participate in the study
- Unable to read and write Turkish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
Mothers in this group will receive breastfeeding training using virtual reality glasses.
|
Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins.
Mothers in this group will receive breastfeeding training as part of routine hospital protocol.
|
|
Experimental: Simulation Group
Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins.
|
Mothers in this group will receive breastfeeding training as part of routine hospital protocol.
Mothers in this group will receive breastfeeding training using virtual reality glasses.
|
|
Active Comparator: Control Group
Mothers in this group will receive breastfeeding training as part of routine hospital protocol.
|
Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins.
Mothers in this group will receive breastfeeding training using virtual reality glasses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mother's Breastfeeding Strength Scale
Time Frame: up to 12 months
|
This is a 37-item, 5-point Likert-type scale developed to assess mothers' breastfeeding strength level.
Scale items are scored from "1 = Strongly disagree" to "5 = Strongly agree."
There are no reverse-scored items.
The total score ranges from 37 to 185.
A higher total score indicates a higher level of breastfeeding strength in the mother.
Subscale scores are calculated by summing the items in the relevant subscale.
Higher scores indicate a more positive situation in terms of breastfeeding knowledge and skills, perceived competence, beliefs about breastfeeding, coping with breastfeeding problems, providing family support, and breastfeeding self-efficacy.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bristol Breastfeeding Assessment Scale
Time Frame: up to 12 months
|
Developed by Jenny Ingram in 2014 and adapted into Turkish by Dolgun et al. in 2017, the scale is designed to assess common breastfeeding problems and adequacy in the postpartum period.
The mother is observed by a midwife/nurse during breastfeeding, and the form is completed based on the criteria, evaluating both mother and baby.
The application time is 5-10 minutes.
While the original version of the scale had a Cronbach's Alpha of 0.68, the Turkish adaptation yielded 0.77.
In our study, the reliability coefficient was determined to be 0.87.
The measurement tool is a Likert-type scale consisting of 4 items: "positioning," "holding," "sucking," and "swallowing."
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
August 12, 2026
First Submitted That Met QC Criteria
August 12, 2026
First Posted (Actual)
August 17, 2026
Study Record Updates
Last Update Posted (Actual)
August 17, 2026
Last Update Submitted That Met QC Criteria
August 12, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breastfeeding success
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.