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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Mersin, Turkey
        • Mersin University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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".
Other: Virtual reality glasses
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breast Milk Quantity Monitoring Form
Time Frame: Up to 3 Months
It is a form consisting of 3 parts developed by the researcher to record information about milking date, milking time and milk amount.
Up to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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