The Effect of Virtual Reality Glasses on Anxiety Level and Breast Milk Amount

Sponsor
Mersin University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06153628
Collaborator
(none)
60
1
1
6.4
9.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality glasses
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single-subject quasi-experimental researchSingle-subject quasi-experimental research
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Nov 3, 2023
Actual Primary Completion Date :
Nov 10, 2023
Anticipated Study Completion Date :
May 15, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. State-Anxiety Inventory [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.

Secondary Outcome Measures

  1. Breast Milk Quantity Monitoring Form [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mersin University Mersin Turkey

Sponsors and Collaborators

  • Mersin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aslı EKER, Dr.Lecturer, Mersin University
ClinicalTrials.gov Identifier:
NCT06153628
Other Study ID Numbers:
  • Mersin Üniversitesi
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aslı EKER, Dr.Lecturer, Mersin University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2023