Virtual RealityNCT05982457
The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching
A study testing virtual reality group in people with Virtual Reality and Educational, run by Sevgi Beyazgül.
Trial summary
The aim of this project is to determine the effect of virtual reality application in cervical dilatation and effacement teaching on students' satisfaction, confidence and anxiety levels. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Educational
- What is being tested?
- virtual reality group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 20 Dec 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a third year student of the Midwifery Department,
- Not having received training in cervical dilation and effacement application
- Volunteering to participate in the study
Who cannot join
- Not voluntarily participating in the study,
- Having received training in cervical dilatation and effacement
About this study
Official title: The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching on Students' Satisfaction, Self-Confidence and Anxiety Levels
The aim of this project is to determine the effect of virtual reality application in cervical dilatation and effacement teaching on students' satisfaction, confidence and anxiety levels.
Read the detailed description
Midwifery education is extremely important in terms of training midwives specialized in mother-child health. Cervical dilation and effacement is one of the subjects that should be learned well in order to manage the birth process well. Dilatation and effacement of the cervix is the enlargement (dilatation) and thinning (effacement) of the cervical opening and cervical canal when labor begins. Cervical dilation and effacement training is a tactile skill practice that requires constant repetition and practice. Therefore, it cannot be learned by observing, effective learning can be achieved by experiencing it repeatedly in pregnant women. Midwifery students gain experience in the teaching process by practicing with simulation training, laboratory studies and clinical applications. When the literature is examined, no study has been found about the virtual reality application related to cervical dilatation and effacement teaching. The study will be an original study as it focuses on the effect of virtual reality application in cervical dilatation and effacement education on students' satisfaction, self-confidence and anxiety levels. The findings of the study will shed light on the literature in terms of determining the effects of virtual reality application on students in cervical dilatation and effacement teaching. In addition, our project will be a pioneering study in terms of the use of virtual reality application in cervical dilatation and effacement teaching. Within the scope of the study, students will be examined in the focus of their satisfaction, self-confidence and anxiety levels. In this respect, the study will increase awareness in terms of revealing the effects of virtual reality application, which is one of the different simulation teaching methods in cervical dilatation and effacement teaching. Students will be examined as part of the study. In this way, students who have not received cervical dilatation and effacement training with virtual reality application before will have the opportunity to evaluate their exposure to this method.
- Conditions
- Virtual Reality, Educational
- Being tested
- virtual reality group
- Keywords
- cervical dilation, midwifery education, simulation, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality groupBehavioural
Before the training, the Descriptive Information Form and the State and Trait Anxiety Inventory as a pre-test will be applied by face interview method. They will study for two hours. After the introduction and information, the lens and pupil distances of the virtual reality Glasses will be adjusted according to each student and students are expected to wear their vision. The application is the same for every student. Students will be introduced through the images projected to the computer simultaneously while in the application. Cervical dilation and effacement application will be monitored using virtual reality glasses. Next, the students will be asked to touch the woman's perineum with their hands to make her image transparent and we ask them to watch the cervix structures again. After the application, "Learning Satisfaction and Self-Confidence in Learning Scale" and "State and Trait Anxiety Inventory" will be applied as a post-test.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality group | Experimental | After the introduction and information is given, the lens and pupil distances of the virtual reality glasses will be adjusted according to each student and the students will be provided to wear them. The application will be made one-on-one with each student. The application will be carried out sitting in the laboratory. While the students are inside the application, the interface will be introduced through the images projected to the computer simultaneously. Cervical dilatation and effacement application will be watched using virtual glasses. Then, the students will be asked to use their hands to touch the perineum of the woman and make the image transparent, and it will be ensured that they watch the cervix structures again. Each student will use the virtual glasses for an average of 20-25 minutes. Receives: Behavioral: virtual reality group |
| Model group | No intervention | After the introduction and briefing, the students will be provided to perform cervical dilatation and effacement application on the model in accordance with the Cervical Dilatation and Effacement Learning Guide with each student in the laboratory environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Information Form
It consists of nine questions questioning students' socio-demographic characteristics, knowledge of cervical dilatation and effacement, and their virtual reality application experiences.
Measured: 5 minutes before the study
Secondary outcomes (1)
Student Satisfaction and Self-Confidence in Learning Scale
In the sub-dimension of satisfaction with learning; In the sub-dimension of self-confidence, five items measuring satisfaction with the teaching method, variety of learning materials, facilitation, motivation and the suitability of simulation in general; The content adequacy includes eight items: self-confidence, content requirement, skill development, available resources, and information on how to get help to solve clinical problems in simulation. Responses are scored on a five-point Likert system, ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score varies between 13-65.
Measured: 5 minutes after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Sep 2023 (estimated)
- Primary completion15 Oct 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sevgi Beyazgül
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevgi Beyazgül, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982457
- Sponsor's protocol ID
- 2023/74
- Status last verified
- Aug 2023
- First submitted
- 12 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching on Students' Satisfaction, Self-Confidence and Anxiety Levels
- ClinicalTrials.gov ID
- NCT05982457
- Acronym / sponsor ID
- 2023/74
- Conditions
- Virtual Reality, Educational
- Keywords
- cervical dilation, midwifery education, simulation, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Sevgi BeyazgülUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 8 Aug 2023 (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 aim of this project is to determine the effect of virtual reality application in cervical dilatation and effacement teaching on students' satisfaction, confidence and anxiety levels.
Detailed description
Midwifery education is extremely important in terms of training midwives specialized in mother-child health. Cervical dilation and effacement is one of the subjects that should be learned well in order to manage the birth process well. Dilatation and effacement of the cervix is the enlargement (dilatation) and thinning (effacement) of the cervical opening and cervical canal when labor begins. Cervical dilation and effacement training is a tactile skill practice that requires constant repetition and practice. Therefore, it cannot be learned by observing, effective learning can be achieved by experiencing it repeatedly in pregnant women. Midwifery students gain experience in the teaching process by practicing with simulation training, laboratory studies and clinical applications. When the literature is examined, no study has been found about the virtual reality application related to cervical dilatation and effacement teaching. The study will be an original study as it focuses on the effect of virtual reality application in cervical dilatation and effacement education on students' satisfaction, self-confidence and anxiety levels. The findings of the study will shed light on the literature in terms of determining the effects of virtual reality application on students in cervical dilatation and effacement teaching. In addition, our project will be a pioneering study in terms of the use of virtual reality application in cervical dilatation and effacement teaching. Within the scope of the study, students will be examined in the focus of their satisfaction, self-confidence and anxiety levels. In this respect, the study will increase awareness in terms of revealing the effects of virtual reality application, which is one of the different simulation teaching methods in cervical dilatation and effacement teaching. Students will be examined as part of the study. In this way, students who have not received cervical dilatation and effacement training with virtual reality application before will have the opportunity to evaluate their exposure to this method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality group | Experimental | Behavioral: virtual reality groupAfter the introduction and information is given, the lens and pupil distances of the virtual reality glasses will be adjusted according to each student and the students will be provided to wear them. The application will be made one-on-one with each student. The application will be carried out sitting in the laboratory. While the students are inside the application, the interface will be introduced through the images projected to the computer simultaneously. Cervical dilatation and effacement application will be watched using virtual glasses. Then, the students will be asked to use their hands to touch the perineum of the woman and make the image transparent, and it will be ensured that they watch the cervix structures again. Each student will use the virtual glasses for an average of 20-25 minutes. |
| Model group | No intervention | –After the introduction and briefing, the students will be provided to perform cervical dilatation and effacement application on the model in accordance with the Cervical Dilatation and Effacement Learning Guide with each student in the laboratory environment. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being a third year student of the Midwifery Department,
- Not having received training in cervical dilation and effacement application
- Volunteering to participate in the study
Key exclusion criteria (2 listed)
- Not voluntarily participating in the study,
- Having received training in cervical dilatation and effacement
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 groupBefore the training, the Descriptive Information Form and the State and Trait Anxiety Inventory as a pre-test will be applied by face interview method. They will study for two hours. After the introduction and information, the lens and pupil distances of the virtual reality Glasses will be adjusted according to each student and students are expected to wear their vision. The application is the same for every student. Students will be introduced through the images projected to the computer simultaneously while in the application. Cervical dilation and effacement application will be monitored using virtual reality glasses. Next, the students will be asked to touch the woman's perineum with their hands to make her image transparent and we ask them to watch the cervix structures again. After the application, "Learning Satisfaction and Self-Confidence in Learning Scale" and "State and Trait Anxiety Inventory" will be applied as a post-test. | Behavioural | virtual reality group |
Primary outcome
Descriptive Information Form
Time frame: 5 minutes before the study
It consists of nine questions questioning students' socio-demographic characteristics, knowledge of cervical dilatation and effacement, and their virtual reality application experiences.
1 secondary outcome
Student Satisfaction and Self-Confidence in Learning Scale
Time frame: 5 minutes after the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality group in people with Virtual Reality and Educational, run by Sevgi Beyazgül.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2023. 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?
Results are not available in the source record.
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?
Descriptive Information Form (time frame: 5 minutes before the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.