the Effect of Virtual Reality Glasses on Women Who Milk Their Babies by Milking

NCT07008625 | Not Yet Recruiting

• 1 other identifier: MU-SBF-ZB-01
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The research was conducted at the Istanbul Zeynep Kamil Women's And Children's Diseases Education And Research Hospital's Maternity Service between the dates of June 15 and December 31, 2025. It is a randomized controlled experimental research. The data consist of a total of 32 primiparous mothers whose baby was hospitalized in the neonatal intensive care unit who met the criteria for inclusion in the study. Mothers were divided into groups (16 experiments, 16 controls) by randomization method. The data of the research were collected using the Personal Information Form, the Status Anxiety Scale and the Inadequate Milk Perception Scale after obtaining the permission of the ethics committee and the institution. Virtual reality glasses were applied to the mothers in the experimental group. Only routine clinical care was applied to the mothers in the control group.

Conditions

Human Milk, Breast Milk

Keywords

Breast milk, milking, newborn, virtual reality glasses

Outcome Measures

Primary Outcomes (3)

• Personal Information Form

  In accordance with the relevant literature information provided by the researchers (Sari Ozturk and Demir, 2023; Ferraz Dos Santos et al., 2020) developed (Personal Information Form socio-demographic variables belonging to mothers (age, education level, income level, etc.) obstetric characteristics (pregnancy, miscarriage, number and shape of birth, etc.) consists of 33 questions related to breastfeeding and anxiety.

  2 weeks

• The Status Anxiety Scale

  The status-continuous anxiety scale is a self-assessment questionnaire consisting of short statements. It has been adapted to Turkish by Öner and Le Compte. In this study, only the State Anxiety subscale was used. The reason for this is that the Situational Anxiety Scale describes how an individual feels at a certain moment and under certain conditions, and includes a response taking into account their feelings about the situation they are in, Cronbach's Alpha internal consistency coefficient for the situational anxiety scale was found to be between 0.94 and 0.96 in reliability analyses. Dec. The state anxiety scale consists of a scale consisting of a total of twenty items. There is no time limit for responding to the scale. The emotions or behaviors expressed in the items of the state anxiety scale are answered by marking one of the following styles according to the degree of severity of such experiences: (1) none, (2) a little, (3) a lot, (4) completely.

  2 weeks

• Inadequate Milk Perception Scale

  Inadequate Milk Perception Scale Developed by McCarter-Spaulding and Kearney in 2001, the scale consists of 6 questions to determine the inadequate perception of breast milk. The first question that questions whether the mother perceives her milk adequately is in the form of "yes" or "no". The other 5 questions are aimed at measuring the perception of milk Deciency and are scored between 0-10. "0" indicates that milk is completely inadequately perceived, "10" indicates that milk is completely adequately perceived. The scale is scored between 0-50 Dec. A high score indicates that the competence perception of milk has increased. The Cronbach α value was determined as 0.81 in the original of the scale (McCarter-Spaulding \& Kearney, 2001). The validity reliability of the scale in Turkish was made by Gökçeoğlu and Küçükoğlu and the Cronbach α value of the study was found to be 0.82 (Gökçeoğlu, 2014).

  2 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

virtual reality glasses will be applied

Device: virtual reality glasses

control group

ACTIVE COMPARATOR

only routin clinical care will be applied

Behavioral: routine care

Interventions

virtual reality glasses DEVICE

Experimental Group (Those who applied virtual reality glasses): 1.Stage: The mothers who will be included in the experimental-application group will first be informed about the study and the "Informed Volunteer Consent Form" will be filled out. Then to mothers (breast milk, methods of milking, etc.) information will be provided about. Before milking, the "Personal Information Form", the "Status Anxiety Scale", the "Inadequate Milk Perception Scale" will be applied. After the application of the forms and scales to be used in the study 1.the milking process will be performed (If milking is to be done with a milking machine, the device used will be "Babyvacc Model TBM3100".) and the amount of milk milked will be measured (in a plastic 150 ml sized bottle contained in the Milkvacc breast milk milking and storage kit belonging to Ankalaps Company), and attention will be paid to the inclusion of mothers who have never been able to breastfeed for medical reasons in the study. Mothers in the

experimental group

routine care BEHAVIORAL

1.Stage: The mothers who will be included in the control group will first be informed about the study and the "Informed Volunteer Consent Form" will be filled out. Then to mothers (breast milk, methods of milking, etc.) information will be provided about. Before milking, the "Personal Information Form", the "Status Anxiety Scale", the "Inadequate Milk Perception Scale" will be applied. After the application of the forms and scales to be used in the study, 1.the milking process will be performed (If milking is to be done with a milking machine, the device used will be "Babyvacc Model TBM3100".) and the amount of milk milked will be measured (in a plastic 150 ml sized bottle contained in the Milkvacc breast milk milking and storage kit belonging to Ankalaps Company), and attention will be paid to the inclusion of mothers who have never been able to breastfeed for medical reasons in the study. Mothers in the control group were given 1 during the waiting for the next milking time. and 2. r

control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: only female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• those between the ages of 18-35 December
• Who is at least the first school graduate
• Who can speak and understand Turkish
• who gives birth to a single term at 37-42 weeks of pregnancy
• The primiparous one
• Who gives vaginal birth
• Without any risk related to pregnancy and childbirth
• The baby is in the neonatal intensive care unit
• Giving milk to your baby by milking
• Without any chronic systemic diseases
• End of birth 1-4. what happened between the Dec
• Mothers who volunteer to participate in the study and approve the consent document will be accepted to the study.

You may not qualify if:

• With the loss of a baby during the study phase
• Those who do not want to participate in the study or who voluntarily participated in the study but later gave up will be excluded from the study.

Sponsors & Collaborators

• Marmara University: lead
• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: collaborator

Related Publications (8)

• Karimi M, Haghighat M, Dialameh Z, Tahmasbi L, Parand S, Bardestani M. Breastfeeding as a Protective Effect Against Childhood Leukemia and Lymphoma. Iran Red Crescent Med J. 2016 Feb 13;18(9):e29771. doi: 10.5812/ircmj.29771. eCollection 2016 Sep.

  PMID: 28144455 BACKGROUND

• Joshi A, Amadi C, Meza J, Aguire T, Wilhelm S. Evaluation of a computer-based bilingual breastfeeding educational program on breastfeeding knowledge, self-efficacy and intent to breastfeed among rural Hispanic women. Int J Med Inform. 2016 Jul;91:10-9. doi: 10.1016/j.ijmedinf.2016.04.001. Epub 2016 Apr 2.

  PMID: 27185505 BACKGROUND

• Herlina, N., Ekowati, E., Fratidhina, Y., Nugroho, W., Agustina, I., & Aticeh, A. (2022). Virtual Reality (VR) Glasses for Oxytocin Relaxation Therapy to Increase Breast Milk Production of Postpartum Mothers. Jurnal Midpro. https://doi.org/10.30736/md.v14i1.418.

  BACKGROUND

• Ferraz Dos Santos L, Borges RF, de Azambuja DA. Telehealth and Breastfeeding: An Integrative Review. Telemed J E Health. 2020 Jul;26(7):837-846. doi: 10.1089/tmj.2019.0073. Epub 2019 Oct 18.

  PMID: 31633467 BACKGROUND

• Elgzar WT, Al-Thubaity DD, Alshahrani MA, Essa RM, Ibrahim HA. The Relationship between Maternal Ideation and Exclusive Breastfeeding Practice among Saudi Nursing Mothers: A Cross-Sectional Study. Nutrients. 2023 Mar 31;15(7):1719. doi: 10.3390/nu15071719.

  PMID: 37049559 BACKGROUND

• Dantas DC, Goes FGB, Santos ASTD, Silva ACSSD, Silva MDA, Silva LFD. Production and validation of educational video to encourage breastfeeding. Rev Gaucha Enferm. 2022 Aug 15;43:e20210247. doi: 10.1590/1983-1447.2022.20210247.en. eCollection 2022. English, Portuguese.

  PMID: 35976384 BACKGROUND

• Chen FQ, Leng YF, Ge JF, Wang DW, Li C, Chen B, Sun ZL. Effectiveness of Virtual Reality in Nursing Education: Meta-Analysis. J Med Internet Res. 2020 Sep 15;22(9):e18290. doi: 10.2196/18290.

  PMID: 32930664 BACKGROUND

• Armstrong M, Lun J, Groner JI, Thakkar RK, Fabia R, Noffsinger D, Ni A, Keesari R, Xiang H. Mobile phone virtual reality game for pediatric home burn dressing pain management: a randomized feasibility clinical trial. Pilot Feasibility Stud. 2022 Aug 18;8(1):186. doi: 10.1186/s40814-022-01150-9.

  PMID: 35982492 BACKGROUND

Central Study Contacts

zehra karahan acar, bachelor

CONTACT

905051202747; karahanzehrakz@gmail.com

zümrüt bilgin, assistant professor

CONTACT

905355556000; zumrutbilgin@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: virtual reality glasses will be applied to the experimental group that was blinded, and routine clinical care will be given to the control group that was blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: It is a randomized controlled experimental research type.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: May 27, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share