AnxietyNCT06153628
The Effect of Virtual Reality Glasses on Anxiety Level and Breast Milk Amount
A study testing Virtual reality glasses in people with Anxiety and Amount of Breast Milk, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application. The study was planned to examine the effect of virtual reality glasses applied to mothers whose babies were in the neonatal intensive care unit, on the level of anxiety and the amount of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Amount of Breast Milk
- What is being tested?
- Virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2023to 15 Jun 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are between the ages of 18-45,
- Those who gave birth at a gestational age of 30 weeks or more,
- whose baby is still in intensive care,
- whose baby has started breastfeeding,
- Giving breast milk to her baby by expressing,
- Not using any medication that will affect milk supply,
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- Not diagnosed with a psychiatric disease that will affect breastfeeding in the postpartum period,
- Those who have not had any breast-related surgery before,
- Understands Turkish and can communicate,
- Mothers who sign the Informed Volunteer Consent Form will be included in the research.
Who cannot join
- Those who are younger than 18 years of age or older than 45 years of age,
- The gestational age is less than 30 weeks,
- whose baby was discharged from intensive care,
- whose baby has not started breastfeeding,
- Those who do not express breast milk to their babies,
- Using medication that will affect milk supply,
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- Diagnosed with a psychiatric disease that will affect breastfeeding in the postpartum period,
- Have had any breast-related surgery before,
- Cannot communicate in Turkish,
- Mothers who do not sign the Informed Volunteer Consent Form will not be included in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses Applied to Mothers Whose Babies Are in the Neonatal Intensive Care Unit on the Level of Anxiety and the Amount of Breast Milk
Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application. The study was planned to examine the effect of virtual reality glasses applied to mothers whose babies were in the neonatal intensive care unit, on the level of anxiety and the amount of breast milk.
Read the detailed description
Although milk is expressed early and frequently, milk volume and milk production may be lower in some mothers in the first few weeks.For this reason, pharmacological and non-pharmacological methods have been focused on to increase prolactin secretion and breast milk production in mothers with premature babies. It is emphasized that practices such as breast massage, hot application, nutrition and fluid consumption of the mother, thinking about her baby or looking at her picture, and psychological relaxation during milk expression with a pump increase the amount of milk. It is thought that the mother's stress and anxiety negatively affect the amount of breast milk in preterm births, and that methods that provide relaxation and relief will contribute to breast milk production by reducing stress and anxiety. Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application.
- Conditions
- Anxiety, Amount of Breast Milk
- Being tested
- Virtual reality glasses
- Keywords
- Anxiety, Breast milk, Breastfeeding, Premature, Virtual reality glasses
- Medical subject headings
- Anxiety Disorders, 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 glassesOther
Videos consisting of nature and undersea images will be played through virtual reality glasses, which the woman wants to watch and can change whenever she wants.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses | Experimental | First of all, the "State Anxiety Inventory" will be applied to all women (60 women).Then, milk will be expressed from both breasts once a day (10:00) for the first 3 days and the amount of milk expressed will be recorded in the "Breast Milk Amount Tracking Form". After the first 3 days, all women will be relaxed by watching virtual reality glasses (10 minutes) once a day (10:00 in the morning) for 3 days, and the "State Anxiety Inventory" will be applied at the end of the video. Then, milk will be expressed from both breasts and recorded in the "Breast Milk Amount Tracking Form". Receives: Other: Virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Anxiety Inventory
In the Likert-type scale consisting of 20 items, the items are numbered from 1 to 4 (1 means "not at all" and 4 means "completely").The scores obtained from the scale vary between 20 and 80 and there are direct (straight) and reversed expressions in the scale.
Measured: Up to 3 Months
Secondary outcomes (1)
Breast Milk Quantity Monitoring Form
It is a form consisting of 3 parts developed by the researcher to record information about milking date, milking time and milk amount.
Measured: Up to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start2 Nov 2023
- Primary completion10 Apr 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject quasi-experimental research
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı EKER, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153628
- Sponsor's protocol ID
- Mersin Üniversitesi
- Status last verified
- May 2025
- First submitted
- 8 Nov 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kent JC, Geddes DT, Hepworth AR, Hartmann PE. Effect of warm breastshields on breast milk pumping. J Hum Lact. 2011 Nov;27(4):331-8. doi: 10.1177/0890334411418628.
PubMed 22048756Hill PD, Aldag JC, Chatterton RT. Effects of pumping style on milk production in mothers of non-nursing preterm infants. J Hum Lact. 1999 Sep;15(3):209-16. doi: 10.1177/089033449901500310.
PubMed 10578798
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Applied to Mothers Whose Babies Are in the Neonatal Intensive Care Unit on the Level of Anxiety and the Amount of Breast Milk
- ClinicalTrials.gov ID
- NCT06153628
- Acronym / sponsor ID
- Mersin Üniversitesi
- Conditions
- Anxiety, Amount of Breast Milk
- Keywords
- Anxiety, Breast milk, Breastfeeding, Premature, Virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 1 Dec 2023 (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.
Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application. The study was planned to examine the effect of virtual reality glasses applied to mothers whose babies were in the neonatal intensive care unit, on the level of anxiety and the amount of breast milk.
Detailed description
Although milk is expressed early and frequently, milk volume and milk production may be lower in some mothers in the first few weeks.For this reason, pharmacological and non-pharmacological methods have been focused on to increase prolactin secretion and breast milk production in mothers with premature babies. It is emphasized that practices such as breast massage, hot application, nutrition and fluid consumption of the mother, thinking about her baby or looking at her picture, and psychological relaxation during milk expression with a pump increase the amount of milk. It is thought that the mother's stress and anxiety negatively affect the amount of breast milk in preterm births, and that methods that provide relaxation and relief will contribute to breast milk production by reducing stress and anxiety. Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject quasi-experimental research
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses | Experimental | Other: Virtual reality glassesFirst of all, the "State Anxiety Inventory" will be applied to all women (60 women).Then, milk will be expressed from both breasts once a day (10:00) for the first 3 days and the amount of milk expressed will be recorded in the "Breast Milk Amount Tracking Form". After the first 3 days, all women will be relaxed by watching virtual reality glasses (10 minutes) once a day (10:00 in the morning) for 3 days, and the "State Anxiety Inventory" will be applied at the end of the video. Then, milk will be expressed from both breasts and recorded in the "Breast Milk Amount Tracking Form". |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Are between the ages of 18-45,
- Those who gave birth at a gestational age of 30 weeks or more,
- whose baby is still in intensive care,
- whose baby has started breastfeeding,
- Giving breast milk to her baby by expressing,
Key exclusion criteria (10 listed)
- Those who are younger than 18 years of age or older than 45 years of age,
- The gestational age is less than 30 weeks,
- whose baby was discharged from intensive care,
- whose baby has not started breastfeeding,
- Those who do not express breast milk to their babies,
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 glassesVideos consisting of nature and undersea images will be played through virtual reality glasses, which the woman wants to watch and can change whenever she wants. | Other | Virtual reality glasses |
Primary outcome
State-Anxiety Inventory
Time frame: Up to 3 Months
In the Likert-type scale consisting of 20 items, the items are numbered from 1 to 4 (1 means "not at all" and 4 means "completely").The scores obtained from the scale vary between 20 and 80 and there are direct (straight) and reversed expressions in the scale.
1 secondary outcome
Breast Milk Quantity Monitoring Form
Time frame: Up to 3 Months
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 11 May 2025.
- Results publication: PubMed 22048756Kent JC, Geddes DT, Hepworth AR, Hartmann PE. Effect of warm breastshields on breast milk pumping. J Hum Lact. 2011 Nov;27(4):331-8. doi: 10.1177/0890334411418628.
- Results publication: PubMed 10578798Hill PD, Aldag JC, Chatterton RT. Effects of pumping style on milk production in mothers of non-nursing preterm infants. J Hum Lact. 1999 Sep;15(3):209-16. doi: 10.1177/089033449901500310.
- World Health Organization Report of the Expert Consultation on the Optimal Duration of Exclusive Breastfeeding. Geneva, World Health Organization 2001,Link provided by the sponsor.
- Gartner LM, Morton J, Lawrence RA, Naylor AJ, O'Hare D, Schanler RJ et al. American Academy of Pediatrics Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics 2005; 115: 496-506Link provided by the sponsor.
- American Academy of Family Physicians (AAFP) (2007). Breastfeeding (policy statement). In. Appendix 2: Additional Breastfeeding Considerations 2010; 13-14Link provided by the sponsor.
- World Health Organization. The Global Action Report on Preterm Birth, 2012; 1-126Link provided by the sponsor.
- 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 glasses in people with Anxiety and Amount of Breast Milk, run by Mersin 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 10 inclusion and 10 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 11 May 2025. 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?
State-Anxiety Inventory (time frame: Up to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06153628, which also lists 2 linked publications.
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 11 May 2025.