Human Milk, Breast MilkNCT07008625
the Effect of Virtual Reality Glasses on Women Who Milk Their Babies by Milking
A study testing virtual reality glasses and routine care in people with Human Milk, Breast Milk, run by Marmara University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Human Milk, Breast Milk
- What is being tested?
- virtual reality glasses and routine care
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Show all 12Show fewer
- 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.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Virtual Reality Application on Anxiety and Milk Quantity in Mothers Who Milk Their Babies by Milking
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.
Read the detailed description
Type of Research: It is a randomized controlled experimental research type.February Decembers/Sample of the Research: The research will be conducted between 3 February 2025-31 December 2025 after obtaining the approval of the ethics committee and the authorizations of the institution.
February December 3, 2025-31, 2025, SBU Zeynep Kamil Women's and Children's Diseases Training and Research Hospital Dec. 3, 2025, the universe of the research will be composed of primiparous mothers whose baby is hospitalized in the neonatal unit. Primiparous mothers (a total of 32 mothers) who participated wholeheartedly in the study will constitute the sample.
Working Group Power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated using the G*Power 3.1 program. As a similar research in the relevant literature, the effect size of the change in the amount of breast milk was calculated as 1.354 in the study conducted by Herlina et al. (2022). In order to exceed the 99% value in determining the strength of the study, it is necessary to reach 26 people, including 13 people in groups with a significance level of 5% and an effect size of 1,354(df=41; t=1,683). In the research, it was aimed to reach a total of 32 people, including 16 people in groups, taking into account the high strength of the test and the losses.
Statistical Analysis of the Data The data obtained in the research will be analyzed using the Statistical Package for Social Sciences (SPSS) for Windows 22.0 program. The Kolmogorov Smirnov Test will be used to determine whether the research data are distributed normally. According to the Kolmogorov Smirnov Test, if p>0.05, the distribution is determined to be normal. However, if p<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are checked. If the Skewness and Kurtosis values are between +2 and -2, it is assumed that the variable shows a normal distribution (George, Dec and Mallery, 2010). The homogeneity of the descriptive characteristics between the groups will be tested by chi-square analysis.Dec. For the difference between the averages of two independent groups, the data will be evaluated using the t-test if they are Decently distributed, and the Mann-Whitney U test if the data are not decently distributed. Changes in measurements within the group if the data are distributed normally, repeated measurements will be analyzed by Anova test, and if the data are not distributed normally, Friedman test.
The Hypotheses of the Research H1. Virtual reality application is effective in increasing the amount of breast milk.
H2. Virtual reality application is not effective in increasing the amount of breast milk.
H3. Virtual reality application is effective in reducing mother's anxiety. H4. The virtual reality application is not effective in reducing the anxiety of the mother.
Collection of Data and Data Collection Tools After explaining that the purpose of the research and all kinds of information about them will be kept confidential to primiparous mothers who are hospitalized at SBU Zeynep Kamil Women's and Pediatrics Training and Research Hospital, whose babies receive care in the neonatal intensive care unit and meet the criteria for admission to the research, the Personal Information Form, the Status Anxiety Scale and the Inadequate Milk Perception Scale will be completed by the researchers using the face-to-face interview technique by having those who volunteer to participate sign an Informed Consent Form. The data collection time will take about 15-20 minutes.
- Personal Information Form: According to 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.
- State Anxiety Scale: The state-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. There are two types of expressions in the scale. We can call these direct or flat and inverted expressions. Direct expressions express negative emotions, while reversed expressions express positive emotions. When scoring these second types of expressions, those with a weight of 1 turn into 4, and those with a weight of 4 turn into 1. Responses with a value of 4 in direct statements indicate that anxiety is high. The reversed expressions are also; answers with a value of 1 indicate high anxiety, those with a value of 4 indicate low anxiety. The expression "I am restless" can be shown directly, and the expression "I Feel Calm" can also be shown as examples of reversed expressions. In this case, if 1 weighted option is selected for the expression "I am restless", these responses reflect high anxiety. There are ten reversed expressions in the Situational Anxiety Scale. These Are; 1, 2, 5, 8, 10, 11, 15, 16, 19 and they are the 20th articles. The total score of the direct and reversed expressions is calculated. From the total score obtained for direct expressions, the total score of reversed expressions is subtracted. A previously determined invariant value is added to this number. For the Status Anxiety Scale, this value is 50. In addition, this scale can score between 20-80 saras and one point above the standard deviation has been accepted as a cut-off point (Oner and Le Compte 1985).
- Inadequate Milk Perception Scale: Inadequate Milk Perception Scale The scale developed by McCarter-Spaulding and Kearney in 2001 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).
- Virtual reality glasses (Game-Based) application: The content in the section "Methods of Milking" contained in the General Directorate of Public Health (HSGM) Breastfeeding Counseling Practitioner Book (2018) will be taken into account when determining the methods of breastfeeding that will be designed in the game in the research (HSGM, 2018). Since the easiest methods of milking are machine and manual milking methods, one of these methods will be selected as a milking method. Virtual reality application will be made to the experimental group and mothers will be informed about the method. Mothers who will apply the virtual reality glasses will be asked to choose any of 4 different types of videos and visuals from the visuals and videos designed for mothers to watch "during waiting for the milking time". The researcher, in accordance with the mother's request, will open the video or image determined by the mother while she is waiting for the milking time and help her watch it. He will be provided to watch videos and visuals at 1 hour intervals and for 15 minutes until the December milking time arrives.
The duration and frequency of watching all the designed videos and images will be determined as an average of 15 minutes according to the time of milking and filling the breasts with milk again.
10.6.2 Collection of Data
Experimental Group (Those who applied virtual reality glasses):
- 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 will be told about the use of virtual reality glasses (SG) while waiting for the next milking time, and the first 1. Per hour and 2.SG will be applied per hour (1. Practice- 15 min), (2. practice-15 min). 2.2 for a period of 15-20 minutes at the end of the hour. the milking process will be performed.
- Stage: After the milking process is completed, the "State Anxiety Scale" and the "Insufficient Milk Perception Scale" will be applied for the second time in the research.
Control Group (Those who underwent routine maintenance):
- 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. routine information will be provided during milking per hour and questions will be answered. 2.2 for a period of 15-20 minutes at the end of the hour. the milking process will be performed.
- Stage: After the milking process is completed, the "State Anxiety Scale" used in the research and the "Insufficient Milk Perception Scale"will be applied for the second time. After that, information will be given to the mothers in this group about the application of virtual reality.
- Conditions
- Human Milk, Breast Milk
- Being tested
- virtual reality glasses, routine care
- Keywords
- Breast milk, milking, newborn, virtual reality glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
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
routine careBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | virtual reality glasses will be applied Receives: Device: virtual reality glasses |
| control group | Active comparator | only routin clinical care will be applied Receives: Behavioral: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start27 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Human Milk, Breast MilkStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized controlled experimental research type.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Responsible party
- Principal investigator, Zümrüt Bingin, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008625
- Sponsor's protocol ID
- MU-SBF-ZB-01
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I'm not sure to share my research.
Publications
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.
PubMed 28144455Joshi 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.
PubMed 27185505Herlina, 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.
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.
PubMed 31633467Elgzar 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.
PubMed 37049559Dantas 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.
PubMed 35976384Chen 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.
PubMed 32930664Armstrong 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.
PubMed 35982492
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Anxiety and Milk Quantity in Mothers Who Milk Their Babies by Milking
- ClinicalTrials.gov ID
- NCT07008625
- Acronym / sponsor ID
- MU-SBF-ZB-01
- Conditions
- Human Milk, Breast Milk
- Keywords
- Breast milk, milking, newborn, virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Study start
- 27 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type of Research: It is a randomized controlled experimental research type.February Decembers/Sample of the Research: The research will be conducted between 3 February 2025-31 December 2025 after obtaining the approval of the ethics committee and the authorizations of the institution.
February December 3, 2025-31, 2025, SBU Zeynep Kamil Women's and Children's Diseases Training and Research Hospital Dec. 3, 2025, the universe of the research will be composed of primiparous mothers whose baby is hospitalized in the neonatal unit. Primiparous mothers (a total of 32 mothers) who participated wholeheartedly in the study will constitute the sample.
Working Group Power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated using the G*Power 3.1 program. As a similar research in the relevant literature, the effect size of the change in the amount of breast milk was calculated as 1.354 in the study conducted by Herlina et al. (2022). In order to exceed the 99% value in determining the strength of the study, it is necessary to reach 26 people, including 13 people in groups with a significance level of 5% and an effect size of 1,354(df=41; t=1,683). In the research, it was aimed to reach a total of 32 people, including 16 people in groups, taking into account the high strength of the test and the losses.
Statistical Analysis of the Data The data obtained in the research will be analyzed using the Statistical Package for Social Sciences (SPSS) for Windows 22.0 program. The Kolmogorov Smirnov Test will be used to determine whether the research data are distributed normally. According to the Kolmogorov Smirnov Test, if p>0.05, the distribution is determined to be normal. However, if p<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are checked. If the Skewness and Kurtosis values are between +2 and -2, it is assumed that the variable shows a normal distribution (George, Dec and Mallery, 2010). The homogeneity of the descriptive characteristics between the groups will be tested by chi-square analysis.Dec. For the difference between the averages of two independent groups, the data will be evaluated using the t-test if they are Decently distributed, and the Mann-Whitney U test if the data are not decently distributed. Changes in measurements within the group if the data are distributed normally, repeated measurements will be analyzed by Anova test, and if the data are not distributed normally, Friedman test.
The Hypotheses of the Research H1. Virtual reality application is effective in increasing the amount of breast milk.
H2. Virtual reality application is not effective in increasing the amount of breast milk.
H3. Virtual reality application is effective in reducing mother's anxiety. H4. The virtual reality application is not effective in reducing the anxiety of the mother.
Collection of Data and Data Collection Tools After explaining that the purpose of the research and all kinds of information about them will be kept confidential to primiparous mothers who are hospitalized at SBU Zeynep Kamil Women's and Pediatrics Training and Research Hospital, whose babies receive care in the neonatal intensive care unit and meet the criteria for admission to the research, the Personal Information Form, the Status Anxiety Scale and the Inadequate Milk Perception Scale will be completed by the researchers using the face-to-face interview technique by having those who volunteer to participate sign an Informed Consent Form. The data collection time will take about 15-20 minutes.
- Personal Information Form: According to 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.
- State Anxiety Scale: The state-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. There are two types of expressions in the scale. We can call these direct or flat and inverted expressions. Direct expressions express negative emotions, while reversed expressions express positive emotions. When scoring these second types of expressions, those with a weight of 1 turn into 4, and those with a weight of 4 turn into 1. Responses with a value of 4 in direct statements indicate that anxiety is high. The reversed expressions are also; answers with a value of 1 indicate high anxiety, those with a value of 4 indicate low anxiety. The expression "I am restless" can be shown directly, and the expression "I Feel Calm" can also be shown as examples of reversed expressions. In this case, if 1 weighted option is selected for the expression "I am restless", these responses reflect high anxiety. There are ten reversed expressions in the Situational Anxiety Scale. These Are; 1, 2, 5, 8, 10, 11, 15, 16, 19 and they are the 20th articles. The total score of the direct and reversed expressions is calculated. From the total score obtained for direct expressions, the total score of reversed expressions is subtracted. A previously determined invariant value is added to this number. For the Status Anxiety Scale, this value is 50. In addition, this scale can score between 20-80 saras and one point above the standard deviation has been accepted as a cut-off point (Oner and Le Compte 1985).
- Inadequate Milk Perception Scale: Inadequate Milk Perception Scale The scale developed by McCarter-Spaulding and Kearney in 2001 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).
- Virtual reality glasses (Game-Based) application: The content in the section "Methods of Milking" contained in the General Directorate of Public Health (HSGM) Breastfeeding Counseling Practitioner Book (2018) will be taken into account when determining the methods of breastfeeding that will be designed in the game in the research (HSGM, 2018). Since the easiest methods of milking are machine and manual milking methods, one of these methods will be selected as a milking method. Virtual reality application will be made to the experimental group and mothers will be informed about the method. Mothers who will apply the virtual reality glasses will be asked to choose any of 4 different types of videos and visuals from the visuals and videos designed for mothers to watch "during waiting for the milking time". The researcher, in accordance with the mother's request, will open the video or image determined by the mother while she is waiting for the milking time and help her watch it. He will be provided to watch videos and visuals at 1 hour intervals and for 15 minutes until the December milking time arrives.
The duration and frequency of watching all the designed videos and images will be determined as an average of 15 minutes according to the time of milking and filling the breasts with milk again.
10.6.2 Collection of Data
Experimental Group (Those who applied virtual reality glasses):
- 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 will be told about the use of virtual reality glasses (SG) while waiting for the next milking time, and the first 1. Per hour and 2.SG will be applied per hour (1. Practice- 15 min), (2. practice-15 min). 2.2 for a period of 15-20 minutes at the end of the hour. the milking process will be performed.
- Stage: After the milking process is completed, the "State Anxiety Scale" and the "Insufficient Milk Perception Scale" will be applied for the second time in the research.
Control Group (Those who underwent routine maintenance):
- 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. routine information will be provided during milking per hour and questions will be answered. 2.2 for a period of 15-20 minutes at the end of the hour. the milking process will be performed.
- Stage: After the milking process is completed, the "State Anxiety Scale" used in the research and the "Insufficient Milk Perception Scale"will be applied for the second time. After that, information will be given to the mothers in this group about the application of virtual reality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- It is a randomized controlled experimental research type.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: virtual reality glassesvirtual reality glasses will be applied |
| control group | Active comparator | Behavioral: routine careonly routin clinical care will be applied |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- • those between the ages of 18-35 December
Key exclusion criteria (2 listed)
- • With the loss of a baby during the study phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality glassesExperimental 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 | Device | experimental group |
| routine care1.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 | Behavioural | control group |
Primary outcome
Personal Information Form
Time frame: 2 weeks
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.
The Status Anxiety Scale
Time frame: 2 weeks
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.
Inadequate Milk Perception Scale
Time frame: 2 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 28144455Karimi 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.
- Background: PubMed 27185505Joshi 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.
- BackgroundHerlina, 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: PubMed 31633467Ferraz 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.
- Background: PubMed 37049559Elgzar 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.
- Background: PubMed 35976384Dantas 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.
- Background: PubMed 32930664Chen 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.
- Background: PubMed 35982492Armstrong 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.
- Individual participant dataSharing planned: No. I'm not sure to share my research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses and routine care in people with Human Milk, Breast Milk, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zehra karahan acar, bachelor (905051202747, karahanzehrakz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07008625, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.