- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06153628
The Effect of Virtual Reality Glasses on Anxiety Level and Breast Milk Amount
May 6, 2025 updated by: Aslı EKER, Mersin University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
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 Locations
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Mersin, Turkey
- Mersin University
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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:
- 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,
- 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.
Exclusion Criteria:
- 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,
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Virtual reality glasses
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".
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State-Anxiety Inventory
Time Frame: Up to 3 Months
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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.
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Up to 3 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Breast Milk Quantity Monitoring Form
Time Frame: Up to 3 Months
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It is a form consisting of 3 parts developed by the researcher to record information about milking date, milking time and milk amount.
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Up to 3 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hill 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.
- 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.
Helpful Links
- World Health Organization Report of the Expert Consultation on the Optimal Duration of Exclusive Breastfeeding. Geneva, World Health Organization 2001,
- 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: 496-506
- American Academy of Family Physicians (AAFP) (2007). Breastfeeding (policy statement). In. Appendix 2: Additional Breastfeeding Considerations 2010; 13-14
- World Health Organization. The Global Action Report on Preterm Birth, 2012; 1-126
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 (Actual)
November 2, 2023
Primary Completion (Actual)
April 10, 2024
Study Completion (Actual)
June 15, 2024
Study Registration Dates
First Submitted
November 8, 2023
First Submitted That Met QC Criteria
November 29, 2023
First Posted (Actual)
December 1, 2023
Study Record Updates
Last Update Posted (Actual)
May 11, 2025
Last Update Submitted That Met QC Criteria
May 6, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mersin Üniversitesi
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
product manufactured in and exported from the U.S.
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.
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