LactationNCT07336186
The Effect of Virtual Reality-Based Relaxation on Breast Milk Volume and Breastfeeding Self-Efficacy in Mothers of Preterm Infants
A study testing Virtual Reality-Based Relaxation in people with Lactation and Breastfeeding, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether using virtual reality (VR) for relaxation helps mothers of premature babies produce more breast milk and feel more confident about breastfeeding. Mothers in the intervention group used VR headsets to watch calming nature videos while listening to music before expressing milk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation, Breastfeeding, Premature Birth
- What is being tested?
- Virtual Reality-Based Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers who have given birth to a single infant between 32 and 35 weeks of gestation.
- Mothers whose infants are hospitalized in the Neonatal Intensive Care Unit (NICU).
- Mothers who have delivered via Cesarean section.
- First-time mothers (Primiparous).
- Mothers who are willing to provide breast milk and participate in the study.
- Mothers whose infants are not yet able to breastfeed directly and require milk expression.
Who cannot join
- Mothers with any systemic or psychiatric diseases.
- Mothers with obstetric complications.
- Mothers who have a history of using addictive substances.
- Mothers who use medications or herbal products to increase breast milk (galactagogues).
- Mothers with hearing or vision impairments that would prevent the use of a VR headset.
- Mothers whose infants have congenital anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Virtual Reality-Assisted Relaxation on Breastfeeding Self-Efficacy and Breast Milk Production in Mothers of Premature Infants: A Randomized Controlled Trial
This study evaluates whether using virtual reality (VR) for relaxation helps mothers of premature babies produce more breast milk and feel more confident about breastfeeding. Mothers in the intervention group used VR headsets to watch calming nature videos while listening to music before expressing milk. The study compares their milk volume and self-efficacy scores to a control group receiving standard care.
Read the detailed description
The purpose of this study is to evaluate the impact of a virtual reality (VR) relaxation intervention on breast milk production and breastfeeding confidence in mothers of premature infants.
Methodology:
- The study followed a randomized controlled design with two parallel groups.
- A total of 44 mothers whose infants were hospitalized in a Level II Neonatal Intensive Care Unit were enrolled.
- Participants were randomly assigned to either the intervention group or the control group.
Intervention and Procedures:
- Intervention Group: Participants used a VR headset to watch a 10-minute video featuring nature landscapes accompanied by classical music. Following the video, the researcher performed manual milk expression for at least 20 minutes.
- Control Group: Participants sat in the same breastfeeding room but did not use the VR headset. They received the same manual milk expression procedure by the same researcher.
- The procedure was conducted once daily for three consecutive days for both groups.
- To maintain stability in milk fat content, all sessions took place between 12:00 and 14:00.
Data Collection:
- Daily milk volume was measured in milliliters using sterile containers or injectors.
- Breastfeeding self-efficacy was assessed at the end of the third day using the "Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants".
- Demographic information was collected at the beginning of the study using a personal information form.
- Conditions
- Lactation, Breastfeeding, Premature Birth, Maternal Stress, Self-Efficacy
- Being tested
- Virtual Reality-Based Relaxation
- Keywords
- Virtual Reality, Relaxation techniques, Breast milk volume, Breastfeeding self-efficacy
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based RelaxationBehavioural
A 10-minute immersive VR experience featuring calming nature landscapes and classical music designed to reduce stress and promote let-down reflex before milk expression.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Mothers in this group used a virtual reality (VR) headset before the milk expression process. They watched a 10-minute relaxation video consisting of nature scenes (forests, waterfalls) accompanied by classical music. After the session, the researcher performed manual milk expression for at least 20 minutes. This procedure was repeated once daily for three days. Receives: Behavioral: Virtual Reality-Based Relaxation |
| Control Group | No intervention | Mothers in this group received standard care. They sat in the same breastfeeding room for 10 minutes but did not use the VR headset or any other relaxation intervention. Following this period, the researcher performed manual milk expression for at least 20 minutes using the same technique as the experimental group. This procedure was repeated once daily for three days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Breast Milk Volume
The total amount of breast milk expressed manually during the study session.
Measured: Daily for 3 consecutive days.
Secondary outcomes (1)
Breastfeeding Self-Efficacy Scale Score
Maternal confidence in breastfeeding as measured by the "Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants" (BSES-SF-PI). The scale consists of 20 items. Total scores range from 20 to 100, where higher scores indicate higher levels of breastfeeding self-efficacy.
Measured: At the end of the 3rd day of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies 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
- Model description
- Participants were randomly assigned to either an experimental group receiving VR-based relaxation or a control group receiving standard care. Both groups were followed simultaneously for a period of three days to compare outcomes.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzi Özdemir, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336186
- Sponsor's protocol ID
- Suzi-04
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 13 Jan 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Reality-Assisted Relaxation on Breastfeeding Self-Efficacy and Breast Milk Production in Mothers of Premature Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07336186
- Acronym / sponsor ID
- Suzi-04
- Conditions
- Lactation, Breastfeeding, Premature Birth, Maternal Stress, Self-Efficacy
- Keywords
- Virtual Reality, Relaxation techniques, Breast milk volume, Breastfeeding self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 13 Jan 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.
This study evaluates whether using virtual reality (VR) for relaxation helps mothers of premature babies produce more breast milk and feel more confident about breastfeeding. Mothers in the intervention group used VR headsets to watch calming nature videos while listening to music before expressing milk. The study compares their milk volume and self-efficacy scores to a control group receiving standard care.
Detailed description
The purpose of this study is to evaluate the impact of a virtual reality (VR) relaxation intervention on breast milk production and breastfeeding confidence in mothers of premature infants.
Methodology:
- The study followed a randomized controlled design with two parallel groups.
- A total of 44 mothers whose infants were hospitalized in a Level II Neonatal Intensive Care Unit were enrolled.
- Participants were randomly assigned to either the intervention group or the control group.
Intervention and Procedures:
- Intervention Group: Participants used a VR headset to watch a 10-minute video featuring nature landscapes accompanied by classical music. Following the video, the researcher performed manual milk expression for at least 20 minutes.
- Control Group: Participants sat in the same breastfeeding room but did not use the VR headset. They received the same manual milk expression procedure by the same researcher.
- The procedure was conducted once daily for three consecutive days for both groups.
- To maintain stability in milk fat content, all sessions took place between 12:00 and 14:00.
Data Collection:
- Daily milk volume was measured in milliliters using sterile containers or injectors.
- Breastfeeding self-efficacy was assessed at the end of the third day using the "Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants".
- Demographic information was collected at the beginning of the study using a personal information form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either an experimental group receiving VR-based relaxation or a control group receiving standard care. Both groups were followed simultaneously for a period of three days to compare outcomes.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Virtual Reality-Based RelaxationMothers in this group used a virtual reality (VR) headset before the milk expression process. They watched a 10-minute relaxation video consisting of nature scenes (forests, waterfalls) accompanied by classical music. After the session, the researcher performed manual milk expression for at least 20 minutes. This procedure was repeated once daily for three days. |
| Control Group | No intervention | –Mothers in this group received standard care. They sat in the same breastfeeding room for 10 minutes but did not use the VR headset or any other relaxation intervention. Following this period, the researcher performed manual milk expression for at least 20 minutes using the same technique as the experimental group. This procedure was repeated once daily for three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mothers who have given birth to a single infant between 32 and 35 weeks of gestation.
- Mothers whose infants are hospitalized in the Neonatal Intensive Care Unit (NICU).
- Mothers who have delivered via Cesarean section.
- First-time mothers (Primiparous).
- Mothers who are willing to provide breast milk and participate in the study.
Key exclusion criteria (6 listed)
- Mothers with any systemic or psychiatric diseases.
- Mothers with obstetric complications.
- Mothers who have a history of using addictive substances.
- Mothers who use medications or herbal products to increase breast milk (galactagogues).
- Mothers with hearing or vision impairments that would prevent the use of a VR headset.
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-Based RelaxationA 10-minute immersive VR experience featuring calming nature landscapes and classical music designed to reduce stress and promote let-down reflex before milk expression. | Behavioural | Virtual Reality Group |
Primary outcome
Daily Breast Milk Volume
Time frame: Daily for 3 consecutive days.
The total amount of breast milk expressed manually during the study session.
1 secondary outcome
Breastfeeding Self-Efficacy Scale Score
Time frame: At the end of the 3rd day of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Relaxation in people with Lactation and Breastfeeding, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Breast Milk Volume (time frame: Daily for 3 consecutive days.). 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 13 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.