PreeclampsiapreeclamsideNCT06730048
The Effect of Augmented Reality Based Training on Preeclampsia Case
A study testing Experimental Group in people with Preeclampsia and Nursing Care, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
However, no study has been found in the care of preeclampsia, which is highly effective on maternal and fetal health. Therefore, this study was planned to determine the effect of augmented reality-based training on the diagnosis and intervention planning skills of nursing students. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Nursing Care, Pregnancy
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 20 Aug 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Continuing the course of Women's Health and Diseases Nursing,
- Volunteering to participate in the research,
- No physical or psychological health problems preventing the completion of the research forms.
Who cannot join
- - Not watching the whole case given with virtual glasses,
- Failure to attend class during the week of the preeclampsia lecture in the course syllabus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Inonu University
Malatya, 44200
simge öztürk, Ph.D, 05398751788, sozturk@bartin.edu.tr
sermin timur taşhan, Ph.D
About this study
Official title: The Effect of Augmented Reality Based Training on Preeclampsia Case on Nursing Students' Diagnosis and Intervention Planning Skills
However, no study has been found in the care of preeclampsia, which is highly effective on maternal and fetal health. Therefore, this study was planned to determine the effect of augmented reality-based training on the diagnosis and intervention planning skills of nursing students.
Read the detailed description
Although pregnancy is a physiological process in women's lives, many women lose their lives due to the lack of timely and appropriate treatment of the complications it brings with it. According to the World Health Organization 2024 report, approximately 800 women die every day due to preventable causes related to pregnancy and childbirth. Preeclampsia, which is among the hypertensive diseases of pregnancy, is a complication of pregnancy and ranks among the top three causes of maternal mortality worldwide. Preeclampsia is defined as hypertension that develops after the 20th week of pregnancy and is accompanied by proteinuria/thrombocytopenia, renal failure, liver dysfunction, and cerebral/visual symptoms.
Considering the risks of preeclampsia complications, taking precautions before the onset of complications and treating complications with appropriate methods are extremely important in reducing the mortality rates of both pregnant and fetus. In order to maintain safe patient care and the health of individuals, nurses should know what kind of nursing care should be applied in the antenatal period to diagnose, evaluate and prevent complications of preeclampsia. In the literature, it is recommended that nursing care for preeclampsia patients should include the diagnoses of infection risk, disruption in sleep pattern, acute pain, constipation, impaired physical movement, lack of self-care, and fatigue. Nursing care should include individualized, holistic, systematic, high quality, feasible, applicable, sustainable care methods including technological methods, models and theories for all pregnant women with more than 2 of the risks of preeclampsia by ACOG.
Technological methods, which have been frequently used in the health system in recent years, are used because they are cheap, usable, accelerate the decision-making process, and reduce workload. Virtual reality (VR) applications are technological applications that create a reality environment with the help of scenarios and facilitate learning complex cases and diseases by increasing students' knowledge and skills. In addition, this method allows students to develop critical thinking skills, participate in clinical decision-making processes and receive feedback. In the literature, VR application has been used in triage patients and nursing care of pediatric patients. However, no study has been found in the care of preeclampsia, which is highly effective on maternal and fetal health. Therefore, this study was planned to determine the effect of augmented reality-based training on the diagnosis and intervention planning skills of nursing students.
- Conditions
- Preeclampsia, Nursing Care, Pregnancy, Augmented Reality
- Being tested
- Experimental Group, Control group (placebo)
- Keywords
- preeclampsia, nursing care, pregnancy, augmented reality
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
An appointment will be made to meet with the students in the experimental group in a suitable classroom of the school. After the pre-test data, the students in the experimental group will be shown the preeclampsia case with virtual glasses for about 5-10 minutes. Then the post-test will be applied. A scenario including preeclampsia case and nursing care practices will be created in the virtual reality environment, and 10 experts will be consulted about the scenario before the students are shown it. This application will not have any side effects.
Control group (placebo)Other
After the pre-test data, the preeclampsia case will be explained to the students in the control group with the classical lecture method in the Women's Health and Diseases Nursing course and the post-test will be applied.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | An appointment will be made to meet with the students in the experimental group in a suitable classroom of the school. After the pre-test data, the students in the experimental group will be shown the preeclampsia case with virtual glasses for about 5-10 minutes. Then the post-test will be applied. A scenario including preeclampsia case and nursing care practices will be created in the virtual reality environment, and 10 experts will be consulted about the scenario before the students are shown it. This application will not have any side effects. Receives: Other: Experimental Group |
| control group | Other | After the pre-test data, the preeclampsia case will be explained to the students in the control group with the classical lecture method in the Women's Health and Diseases Nursing course and the post-test will be applied. Receives: Other: Control group (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia Nursing Care Plan
he nursing care plan consists of 4 open-ended questions including nursing diagnosis, risks, interventions and evaluation. Students will receive 3 points for each correct diagnosis. If they write all of the diagnoses, they will receive a total of 48 points from the diagnoses. If they correctly write 2 of the risk factors related to the diagnosis of preeclampsia added to the diagnoses for each diagnosis, they will receive 1 point from each diagnosis. They will receive a maximum of 16 points from risks. If they write at least 5 nursing interventions for each diagnosis, they will receive 2 points for each diagnosis. A maximum of 32 points will be obtained from interventions. The evaluation part will be 0.25 points. If they write the evaluations of all diagnoses correctly, they will receive 4 points. A total of 100 points can be obtained from the nursing care plan, with a minimum of 0 and a maximum of 48+16+32+32+4.
Measured: one month
Secondary outcomes (3)
Participant Information Form
The information form, which was created by utilizing the literature, consists of a total of 10 questions (student's name, surname, telephone number, student number, age, gender, pre-preparation information, etc.).
Measured: one month
Preeclampsia Knowledge Test
The preeclampsia information form (preeclampsia symptoms, ric factors, laboratory findings of preeclampsia, etc.) created by the researchers in line with the literature consists of a total of 10 questions. Each question is evaluated as 1 point and a minimum score of 0 and a maximum score of 10 can be obtained from the test. Before finalizing the information form, the opinions of 10 experts will be taken to determine its suitability.
Measured: one month
Presence Scale
The Turkish validity and reliability study of the scale developed by Witmer et al. (2005) was conducted by Gökoğlu and Çakıroğlu (2019). Consisting of 29 items, the five-point Likert-type scale has five sub-dimensions: Engagement, Adaptation/Environmentalization, Sensory Engagement, Interaction, and Interface Quality. High scores obtained from the scale indicate that presence is effective.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-group study, experimental and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Ozturk, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730048
- Sponsor's protocol ID
- Inonu3
- Acronym
- preeclamside
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Augmented Reality Based Training on Preeclampsia Case on Nursing Students' Diagnosis and Intervention Planning Skills
- ClinicalTrials.gov ID
- NCT06730048
- Acronym / sponsor ID
- preeclamside / Inonu3
- Conditions
- Preeclampsia, Nursing Care, Pregnancy, Augmented Reality
- Keywords
- preeclampsia, nursing care, pregnancy, augmented reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 12 Dec 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.
However, no study has been found in the care of preeclampsia, which is highly effective on maternal and fetal health. Therefore, this study was planned to determine the effect of augmented reality-based training on the diagnosis and intervention planning skills of nursing students.
Detailed description
Although pregnancy is a physiological process in women's lives, many women lose their lives due to the lack of timely and appropriate treatment of the complications it brings with it. According to the World Health Organization 2024 report, approximately 800 women die every day due to preventable causes related to pregnancy and childbirth. Preeclampsia, which is among the hypertensive diseases of pregnancy, is a complication of pregnancy and ranks among the top three causes of maternal mortality worldwide. Preeclampsia is defined as hypertension that develops after the 20th week of pregnancy and is accompanied by proteinuria/thrombocytopenia, renal failure, liver dysfunction, and cerebral/visual symptoms.
Considering the risks of preeclampsia complications, taking precautions before the onset of complications and treating complications with appropriate methods are extremely important in reducing the mortality rates of both pregnant and fetus. In order to maintain safe patient care and the health of individuals, nurses should know what kind of nursing care should be applied in the antenatal period to diagnose, evaluate and prevent complications of preeclampsia. In the literature, it is recommended that nursing care for preeclampsia patients should include the diagnoses of infection risk, disruption in sleep pattern, acute pain, constipation, impaired physical movement, lack of self-care, and fatigue. Nursing care should include individualized, holistic, systematic, high quality, feasible, applicable, sustainable care methods including technological methods, models and theories for all pregnant women with more than 2 of the risks of preeclampsia by ACOG.
Technological methods, which have been frequently used in the health system in recent years, are used because they are cheap, usable, accelerate the decision-making process, and reduce workload. Virtual reality (VR) applications are technological applications that create a reality environment with the help of scenarios and facilitate learning complex cases and diseases by increasing students' knowledge and skills. In addition, this method allows students to develop critical thinking skills, participate in clinical decision-making processes and receive feedback. In the literature, VR application has been used in triage patients and nursing care of pediatric patients. However, no study has been found in the care of preeclampsia, which is highly effective on maternal and fetal health. Therefore, this study was planned to determine the effect of augmented reality-based training on the diagnosis and intervention planning skills of nursing students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two-group study, experimental and control group
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Experimental GroupAn appointment will be made to meet with the students in the experimental group in a suitable classroom of the school. After the pre-test data, the students in the experimental group will be shown the preeclampsia case with virtual glasses for about 5-10 minutes. Then the post-test will be applied. A scenario including preeclampsia case and nursing care practices will be created in the virtual reality environment, and 10 experts will be consulted about the scenario before the students are shown it. This application will not have any side effects. |
| control group | Other | Other: Control group (placebo)After the pre-test data, the preeclampsia case will be explained to the students in the control group with the classical lecture method in the Women's Health and Diseases Nursing course and the post-test will be applied. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Continuing the course of Women's Health and Diseases Nursing,
Key exclusion criteria (2 listed)
- - Not watching the whole case given with virtual glasses,
- Failure to attend class during the week of the preeclampsia lecture in the course syllabus.
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 |
|---|---|---|
| Experimental GroupAn appointment will be made to meet with the students in the experimental group in a suitable classroom of the school. After the pre-test data, the students in the experimental group will be shown the preeclampsia case with virtual glasses for about 5-10 minutes. Then the post-test will be applied. A scenario including preeclampsia case and nursing care practices will be created in the virtual reality environment, and 10 experts will be consulted about the scenario before the students are shown it. This application will not have any side effects. | Other | experimental group |
| Control group (placebo)After the pre-test data, the preeclampsia case will be explained to the students in the control group with the classical lecture method in the Women's Health and Diseases Nursing course and the post-test will be applied. | Other | control group |
Primary outcome
Preeclampsia Nursing Care Plan
Time frame: one month
he nursing care plan consists of 4 open-ended questions including nursing diagnosis, risks, interventions and evaluation. Students will receive 3 points for each correct diagnosis. If they write all of the diagnoses, they will receive a total of 48 points from the diagnoses. If they correctly write 2 of the risk factors related to the diagnosis of preeclampsia added to the diagnoses for each diagnosis, they will receive 1 point from each diagnosis. They will receive a maximum of 16 points from risks. If they write at least 5 nursing interventions for each diagnosis, they will receive 2 points for each diagnosis. A maximum of 32 points will be obtained from interventions. The evaluation part will be 0.25 points. If they write the evaluations of all diagnoses correctly, they will receive 4 points. A total of 100 points can be obtained from the nursing care plan, with a minimum of 0 and a maximum of 48+16+32+32+4.
3 secondary outcomes
Participant Information Form
Time frame: one month
Preeclampsia Knowledge Test
Time frame: one month
Presence Scale
Time frame: one month
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 12 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Preeclampsia and Nursing Care, run by Inonu 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 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: opening soon, as of the sponsor's last update on 12 Dec 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?
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 simge öztürk, Ph.D (05398751788, sozturk@bartin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia Nursing Care Plan (time frame: one month). 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 12 Dec 2024.