NCT06153628

Brief 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 breast milk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

November 8, 2023

Last Update Submit

May 6, 2025

Conditions

Keywords

AnxietyBreast milkBreastfeedingPrematureVirtual reality glasses

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 3 Months

Secondary Outcomes (1)

  • Breast Milk Quantity Monitoring Form

    Up to 3 Months

Study Arms (1)

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".

Other: Virtual reality glasses

Interventions

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.

Virtual reality glasses

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince the study was about breastfeeding, only women were included.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 22048756BACKGROUND
  • 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.

    PMID: 10578798BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersBreast FeedingPremature Birth

Condition Hierarchy (Ancestors)

Mental DisordersFeeding BehaviorBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single-subject quasi-experimental research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Lecturer

Study Record Dates

First Submitted

November 8, 2023

First Posted

December 1, 2023

Study Start

November 2, 2023

Primary Completion

April 10, 2024

Study Completion

June 15, 2024

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations