Virtual RealityNCT06697769

The Effect of Breastfeeding Experience With Virtual Reality Glasses on Breastfeeding Self-efficacy and Motivation

A study testing virtual reality in people with Virtual Reality and Breastfeeding, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In this study, it was aimed to investigate the effect of breastfeeding experience on breastfeeding self-efficacy and motivation in women with virtual reality simulation. The main question it aims to answer is: Is breastfeeding experience with virtual reality glasses effective in increasing breastfeeding self-efficacy… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Virtual Reality, Breastfeeding
What is being tested?: virtual reality
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2024to 1 Nov 2024
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Pregnant women aged 18 and over,
Which is the primiparous,
36. during the week of pregnancy,
Women whose pregnancy is not in the risky group,
The person who knows how to read and write,
Without visual and auditory disabilities,
There is no breastfeeding barrier,
Pregnant women who have experienced virtual reality breastfeeding experience and filled out the survey forms completely have been included in the research.

Who cannot join

Individuals who did not meet the inclusion criteria were not included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Eskisehir Orhangazi Family Health Center
Eskişehir

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Breastfeeding Experience Presented to Pregnant Women With Virtual Reality Glasses on Breastfeeding Self-efficacy and Breastfeeding Motivation: A Randomized Controlled Trial

Is breastfeeding experience with virtual reality glasses effective in increasing breastfeeding self-efficacy and motivation? They completed the Socio-Demographic and Pregnancy Information Form and the Prenatal Breastfeeding Self-efficacy Scale. Standard breastfeeding training was given. The application group also experienced breastfeeding with a virtual reality simulation. At the end of the application, they filled out the Prenatal Breastfeeding Self-efficacy Scale again. They completed the postpartum Primiparous Breastfeeding Motivation Scale.

Read the detailed description

Aim: In this study, it was aimed to investigate the effect of breastfeeding experience on breastfeeding self-efficacy and motivation in women with virtual reality simulation.

Desing: This study is a randomized controlled trial. Method: A total of 52 people were included in the study, 26 in the control group and 26 in the intervention group. They completed the Socio-Demographic and Pregnancy Information Form and the Prenatal Breastfeeding Self-efficacy Scale. Standard breastfeeding training was given. The application group also experienced breastfeeding with a virtual reality simulation. At the end of the application, they filled out the Prenatal Breastfeeding Self-efficacy Scale again. They completed the postpartum Primiparous Breastfeeding Motivation Scale.

Conditions: Virtual Reality, Breastfeeding
Being tested: virtual reality
Keywords: breastfeeding, virtual reality, pregnant women
Medical subject headings: Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

virtual realityOther
breastfeeding simulation with virtual reality glasses

Study groups in NCT06697769
Study group	Role	What they receive
Virtual Reality	Experimental	Individual standard breastfeeding education was provided. After the training, they experienced the first breastfeeding simulation in a hospital environment for 5 minutes with virtual reality glasses. A week later (37. during the gestational week), they experienced the second breastfeeding simulation in a home environment for 5 minutes with virtual reality glasses. They completed the Prenatal Breastfeeding Self-efficacy Scale (final test). Finally, 1 after giving birth. and 2. they completed the Primiparous Breastfeeding Motivation Scale between months. Opinions were obtained from pregnant women who wanted to express their opinions about the virtual reality glasses breastfeeding simulation experiences. Receives: Other: virtual reality
Control	No intervention	Before starting the study, pregnant women who will be included in the control group according to the inclusion criteria and randomization were informed by the researcher about the study. At the beginning of the study, the control group (36. during the week of pregnancy) pregnant women filled out the Socio-Demographic and Pregnancy Information Form, Prenatal Breastfeeding Self-efficacy Scale (pre-test). Then, individual standard breastfeeding training was given. A week later (37. during the week of pregnancy), they completed the Prenatal Breastfeeding Self-efficacy Scale (final test). Finally, 1 after giving birth. and 2. they completed the Primiparous Breastfeeding Motivation Scale between months.

What is being measured

The primary outcome is the main question the study is designed to answer.

Prenatal Breastfeeding Self-Efficacy Scale
The Prenatal Breastfeeding Self-Efficacy Scale was developed by Wells and colleagues in 2006. The validity and reliability study of the scale in Turkish was conducted by Aydın and Pasinlioğlu in 2018. The scale consists of 20 items and is 5-point likert type. The lowest score to be taken from the scale is 20 and the highest score is 100. An increase in the score obtained from the scale indicates an increase in the perception of breastfeeding self-efficacy. The Cronbach Alpha value of the scale is 0.85.
Measured: The breastfeeding experience with virtual reality glasses lasted 5 minutes. The intervention was repeated a second time a week later over a 5-minute period. After two weeks of intervention, the last Breastfeeding Self-efficacy Scale test was applied.

Secondary outcomes (1)

Primipar Breastfeeding Motivation Scale
The adaptation of the Breastfeeding Motivation Scale developed by Kestler-Peleg (2015) to Turkish was carried out by Mızrak and Özerdogan in 2017. The scale for primiparous mothers consists of 23 items. Items are scored as 1, 2, 3, 4. The total score is not taken from the scale. As the score obtained from the sub-dimension of the scale increases, the motivation representing that sub-dimension also increases. The Cronbach alpha value of the scale is 0.887.
Measured: The scale was completed up to two months after delivery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20241 Nov 2024

First posted20 Nov 2024
Study start1 Jan 2024
Primary completion1 Nov 2024
Study completion1 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Virtual RealityStudies of the same condition, open and under way.
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: A randomized study with a control and intervention group
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06697769
Sponsor's protocol ID: Nebahat ÖZERDOĞAN
Status last verified: Nov 2024
First submitted: 13 Nov 2024
Last updated: 20 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tang K, Gerling K, Chen W, Geurts L. Information and Communication Systems to Tackle Barriers to Breastfeeding: Systematic Search and Review. J Med Internet Res. 2019 Sep 27;21(9):e13947. doi: 10.2196/13947.
PubMed 31573903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Virtual Reality trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Breastfeeding Experience Presented to Pregnant Women With Virtual Reality Glasses on Breastfeeding Self-efficacy and Breastfeeding Motivation: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06697769
Acronym / sponsor ID: Nebahat ÖZERDOĞAN
Conditions: Virtual Reality, Breastfeeding
Keywords: breastfeeding, virtual reality, pregnant women
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Eskisehir Osmangazi UniversityUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 1 Nov 2024 (actual)
Study completion: 1 Nov 2024 (actual)
First posted: 20 Nov 2024 (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.

Detailed description

Aim: In this study, it was aimed to investigate the effect of breastfeeding experience on breastfeeding self-efficacy and motivation in women with virtual reality simulation.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A randomized study with a control and intervention group

Arm	Type	Receives
Virtual Reality	Experimental	Other: virtual realityIndividual standard breastfeeding education was provided. After the training, they experienced the first breastfeeding simulation in a hospital environment for 5 minutes with virtual reality glasses. A week later (37. during the gestational week), they experienced the second breastfeeding simulation in a home environment for 5 minutes with virtual reality glasses. They completed the Prenatal Breastfeeding Self-efficacy Scale (final test). Finally, 1 after giving birth. and 2. they completed the Primiparous Breastfeeding Motivation Scale between months. Opinions were obtained from pregnant women who wanted to express their opinions about the virtual reality glasses breastfeeding simulation experiences.
Control	No intervention	–Before starting the study, pregnant women who will be included in the control group according to the inclusion criteria and randomization were informed by the researcher about the study. At the beginning of the study, the control group (36. during the week of pregnancy) pregnant women filled out the Socio-Demographic and Pregnancy Information Form, Prenatal Breastfeeding Self-efficacy Scale (pre-test). Then, individual standard breastfeeding training was given. A week later (37. during the week of pregnancy), they completed the Prenatal Breastfeeding Self-efficacy Scale (final test). Finally, 1 after giving birth. and 2. they completed the Primiparous Breastfeeding Motivation Scale between months.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Pregnant women aged 18 and over,
Which is the primiparous,
36. during the week of pregnancy,
Women whose pregnancy is not in the risky group,
The person who knows how to read and write,

Key exclusion criteria (1 listed)

Individuals who did not meet the inclusion criteria were not included in the study.

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 realitybreastfeeding simulation with virtual reality glasses	Other	Virtual Reality

Primary outcome

Prenatal Breastfeeding Self-Efficacy Scale
Time frame: The breastfeeding experience with virtual reality glasses lasted 5 minutes. The intervention was repeated a second time a week later over a 5-minute period. After two weeks of intervention, the last Breastfeeding Self-efficacy Scale test was applied.
The Prenatal Breastfeeding Self-Efficacy Scale was developed by Wells and colleagues in 2006. The validity and reliability study of the scale in Turkish was conducted by Aydın and Pasinlioğlu in 2018. The scale consists of 20 items and is 5-point likert type. The lowest score to be taken from the scale is 20 and the highest score is 100. An increase in the score obtained from the scale indicates an increase in the perception of breastfeeding self-efficacy. The Cronbach Alpha value of the scale is 0.85.

1 secondary outcome

Primipar Breastfeeding Motivation Scale
Time frame: The scale was completed up to two months after delivery.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Background: PubMed 31573903Tang K, Gerling K, Chen W, Geurts L. Information and Communication Systems to Tackle Barriers to Breastfeeding: Systematic Search and Review. J Med Internet Res. 2019 Sep 27;21(9):e13947. doi: 10.2196/13947.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Ebru ERTAŞ study chair

ebru.ertas@ksbu.edu.tr

Feride ÇEVİK study chair

feride.cevik@ksbu.edu.tr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality in people with Virtual Reality and Breastfeeding, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

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 8 inclusion and 1 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: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prenatal Breastfeeding Self-Efficacy Scale (time frame: The breastfeeding experience with virtual reality glasses lasted 5 minutes. The intervention was repeated a second time a week later over a 5-minute period. After two weeks of intervention, the last Breastfeeding Self-efficacy Scale test was applied.). 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 NCT06697769, which also lists 1 linked publication.

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 20 Nov 2024.