Postpartum WomenNCT07768527
Virtual Reality and Simulation-Based Breastfeeding Training
A study testing Virtual Reality Group and Simulation Group in people with Postpartum Women and Lactation Power, run by Cukurova University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Women, Lactation Power, Lactation Success
- What is being tested?
- Virtual Reality Group and Simulation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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".
- Being tested
- Virtual Reality Group, Simulation Group, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupBehavioural
Mothers in this group will receive breastfeeding training using virtual reality glasses.
Simulation GroupBehavioural
Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins.
control groupBehavioural
Mothers in this group will receive breastfeeding training as part of routine hospital protocol.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Mothers in this group will receive breastfeeding training using virtual reality glasses. Receives: Behavioral: Simulation Group; Behavioral: control group |
| Simulation Group | Experimental | Mothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins. Receives: Behavioral: Virtual Reality Group; Behavioral: control group |
| Control Group | Active comparator | Mothers in this group will receive breastfeeding training as part of routine hospital protocol. Receives: Behavioral: Virtual Reality Group; Behavioral: Simulation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother's Breastfeeding Strength Scale
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.
Measured: up to 12 months
Secondary outcomes (1)
Bristol Breastfeeding Assessment Scale
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."
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif DAĞLI, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768527
- Sponsor's protocol ID
- Breastfeeding success
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07768527
- Acronym / sponsor ID
- Breastfeeding success
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Simulation Group, Behavioral: control groupMothers in this group will receive breastfeeding training using virtual reality glasses. |
| Simulation Group | Experimental | Behavioral: Virtual Reality Group, Behavioral: control groupMothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins. |
| Control Group | Active comparator | Behavioral: Virtual Reality Group, Behavioral: Simulation GroupMothers in this group will receive breastfeeding training as part of routine hospital protocol. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Primiparous
- Infant in the neonatal period
- Over 18 years of age
- Term delivery
- Healthy baby and individual
Key exclusion criteria (8 listed)
- Multiparous
- Infant not in the neonatal period
- Under 18 years of age
- Premature delivery
- Unhealthy baby and individual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality GroupMothers in this group will receive breastfeeding training using virtual reality glasses. | Behavioural | Control Group, Simulation Group |
| Simulation GroupMothers in this group will receive breastfeeding training using wearable nursing covers and newborn baby mannequins. | Behavioural | Control Group, Virtual Reality Group |
| control groupMothers in this group will receive breastfeeding training as part of routine hospital protocol. | Behavioural | Simulation Group, Virtual Reality Group |
Primary outcome
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.
1 secondary outcome
Bristol Breastfeeding Assessment Scale
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Group and Simulation Group in people with Postpartum Women and Lactation Power, run by Cukurova University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif DAĞLI, Associate Professor (+903223386560 ext. 146, elifarik90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother's Breastfeeding Strength Scale (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.