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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06153628
Other study ID # Mersin Üniversitesi
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 3, 2023
Est. completion date May 15, 2024

Study information

Verified date November 2023
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 breast milk.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 60
Est. completion date May 15, 2024
Est. primary completion date November 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Mersin University Mersin

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Up to 3 Months
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