Cesarean Section ComplicationsNCT06336421
The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous
A study testing Virtual Reality in people with Cesarean Section Complications, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 22 Mar 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Having undergone epidural anesthesia, spinal anesthesia, combined anesthesia,
- Not having an emergency cesarean section,
- Being over 18 years of age,
- Being at least a primary school graduate,
- Not having been diagnosed with a high-risk pregnancy,
- Agreeing to participate in the research voluntarily,
Show all 11Show fewer
- Not having any hearing or vision problems (for the experimental group),
- Not taking medications that affect blood pressure and pulse rate (such as digoxin, adrenaline, dopamine),
- No diagnosed psychiatric disease,
- Being primiparous,
- Being between 38-40 weeks of pregnancy.
Who cannot join
- • Leaving the study at any stage of the research
- Patients who need general anesthesia during surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous During Cesarean Section
Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room.
Read the detailed description
Priority power analysis was performed to determine the size of the study. Cohen's standard field dimensions reference collection method was chosen in the image analysis. Medium effect size (0.5), alpha value compared to the base was determined as 5%, theoretical power was determined as 95% and the minimum volume was determined as 45. 90 pregnant women, 45 of whom were experimental and 45 of whom were controls, met the research criteria and did not agree to participate.Pregnant women in the sample were randomly assigned to two groups using random assignment by assigning them in numerical order.
Criteria for inclusion in the study;
- Having undergone epidural anesthesia, spinal anesthesia, combined anesthesia,
- Not having an emergency cesarean section,
- Being over 18 years of age,
- Being at least a primary school graduate,
- Not having been diagnosed with a high-risk pregnancy,
- Agreeing to participate in the research voluntarily,
- Not having any hearing or vision problems (for the experimental group),
- Not taking medications that affect blood pressure and pulse rate (such as digoxin, adrenaline, dopamine),
- No diagnosed psychiatric disease,
- Being primiparous,
- Being between 38-40 weeks of pregnancy. Exclusion criteria;
- Leaving the study at any stage of the research
- Patients who need general anesthesia during surgery. Pregnant women in the sample were randomly assigned to two groups using random assignment by giving them a numerical order. Then, it was decided by lottery method which group would be the experiment and which group would be the control. Since the data was collected by the researcher during the conduct of the study, blinding was not possible. However, while performing statistical analysis, nicknames were given to the experimental and control groups. Statistical analysis of the data was performed by an independent statistician blinded to the groups. After the analysis, interpretations were made by changing the group names. In this way, statistical bias was prevented during the data analysis step. Therefore, a single blinding technique was used. CONSORT 2010 Flow Diagram guidelines were followed during the research process."Personal Information Form", "State Anxiety Scale" and "Patient Follow-Up Form" were used to collect data in the study. Virtual reality was used as an intervention tool in the research. ntervention Tool Used in the Research: Virtual Reality VR Box brand virtual reality glasses were used in primiparous pregnant women undergoing cesarean section. The video, in which baby pictures will be shown accompanied by virtual reality music, was prepared by the researcher and a faculty member in the music department. During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes.
Data; It was collected face to face by the researcher at the Atatürk University Health Research and Application Center Obstetrics Clinic Operating Room between 01.11.2022 and 15.06.2023. It took an average of 5-10 minutes to fill out the forms.
Process steps Experimental group
- Written consent was obtained from pregnant women who agreed to participate in the study.
- 10 minutes before caesarean section; A personal information form was filled out to determine the descriptive characteristics of the pregnant women.
- Before cesarean section, anxiety level was determined with the State Anxiety Scale.
- Blood pressure, pulse, respiratory rate and saturation in the patient follow-up form were recorded.
- During the cesarean section, the pregnant woman was shown a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes.
- 10 minutes after cesarean section; In order to determine the anxiety level, the parameters in the State Anxiety Scale and the Patient Follow-up Form were measured again and the process was completed. control group
- Written consent was obtained from pregnant women who agreed to participate in the study.
- 10 minutes before cesarean section; A personal information form was filled out to determine the descriptive characteristics of the pregnant women.
- The pregnant woman's anxiety level before the procedure was determined using the State Anxiety Scale.
- Before the procedure, blood pressure, pulse, respiratory rate and saturation in the patient follow-up form were recorded.
- Routine practice was performed during cesarean section.
- 10 minutes after cesarean section; In order to determine the anxiety level, the parameters in the State Anxiety Scale and the Patient Follow-up Form were measured again and the process was completed.
After data collection, evaluation and analysis were done in the SPSS 22 package statistics program. Normality distributions of the data were examined. Skewness-kurtosis values were examined to check whether the data conformed to normal distribution and it was determined that the values of all data were between -1.5 and +1.5. It was determined that parametric testing techniques could be applied. In the analysis of data; number, percentage distribution, mean, standard deviation, chi-square, Independent-samples t test and paired-samples t test were used.
- Conditions
- Cesarean Section Complications
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Cesarean, Primiparous, Anxiety, Vital Signs
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
VR Box brand virtual reality glasses were used in primiparous pregnant women undergoing cesarean section.
During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | virtual reality glasses were used in primiparous pregnant women undergoing cesarean section. The video, in which baby pictures will be shown accompanied by virtual reality music, was prepared by the researcher and a faculty member in the music department. During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes. Receives: Other: Virtual Reality |
| Control group | No intervention | * Written consent was obtained from pregnant women who agreed to participate in the study. * 10 minutes before cesarean section; A personal information form was filled out to determine the descriptive characteristics of the pregnant women. * The pregnant woman's anxiety level before the procedure was determined using the State Anxiety Scale. * Before the procedure, blood pressure, pulse, respiratory rate and saturation in the patient follow-up form were recorded. * Routine practice was performed during cesarean section. * 10 minutes after cesarean section; In order to determine the anxiety level, the parameters in the State Anxiety Scale and the Patient Follow-up Form were measured again and the process was completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
There are 18 questions in this form, prepared by the researchers in line with the literature.
Measured: 8 months
State Anxiety Scale
This scale was developed by Spielberger et al. Developed by. The adaptation of the scale to Turkish and its validity and reliability studies were carried out by Öner and Le Compte in 1983.The scale is a 4-point Likert scale consisting of the options "not at all", "somewhat", "a lot", "completely". There are 10 direct and 10 reversed statements in the scale. Positive (increasing the total anxiety score) for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18 in the scale; 1, 2, 5, 8, 10, 11, 15, 16, 19 Negative scores (reducing the total anxiety score) are obtained for the 20th items. The highest score is 80 and the lowest score is 20. A high total score indicates that the person's anxiety level is also high.Cronbach's alpha coefficient was found to be 0.79 for state anxiety. In this study, Cronbach's Alpha value was found to be 0.83.
Measured: 8 months
Pregnant follow-up form
Blood pressure, pulse, respiration and the amount of oxygen in the blood were measured before and after the procedure and recorded on this form.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Nov 2022
- Primary completion15 Jun 2023
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Aydin, Ataturk University
- Investigators
- Ayşe Aydın, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336421
- Sponsor's protocol ID
- Şuletuvanç
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 28 Mar 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 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous During Cesarean Section
- ClinicalTrials.gov ID
- NCT06336421
- Acronym / sponsor ID
- Şuletuvanç
- Conditions
- Cesarean Section Complications
- Keywords
- Virtual Reality, Cesarean, Primiparous, Anxiety, Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 28 Mar 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.
Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room.
Detailed description
Priority power analysis was performed to determine the size of the study. Cohen's standard field dimensions reference collection method was chosen in the image analysis. Medium effect size (0.5), alpha value compared to the base was determined as 5%, theoretical power was determined as 95% and the minimum volume was determined as 45. 90 pregnant women, 45 of whom were experimental and 45 of whom were controls, met the research criteria and did not agree to participate.Pregnant women in the sample were randomly assigned to two groups using random assignment by assigning them in numerical order.
Criteria for inclusion in the study;
- Having undergone epidural anesthesia, spinal anesthesia, combined anesthesia,
- Not having an emergency cesarean section,
- Being over 18 years of age,
- Being at least a primary school graduate,
- Not having been diagnosed with a high-risk pregnancy,
- Agreeing to participate in the research voluntarily,
- Not having any hearing or vision problems (for the experimental group),
- Not taking medications that affect blood pressure and pulse rate (such as digoxin, adrenaline, dopamine),
- No diagnosed psychiatric disease,
- Being primiparous,
- Being between 38-40 weeks of pregnancy. Exclusion criteria;
- Leaving the study at any stage of the research
- Patients who need general anesthesia during surgery. Pregnant women in the sample were randomly assigned to two groups using random assignment by giving them a numerical order. Then, it was decided by lottery method which group would be the experiment and which group would be the control. Since the data was collected by the researcher during the conduct of the study, blinding was not possible. However, while performing statistical analysis, nicknames were given to the experimental and control groups. Statistical analysis of the data was performed by an independent statistician blinded to the groups. After the analysis, interpretations were made by changing the group names. In this way, statistical bias was prevented during the data analysis step. Therefore, a single blinding technique was used. CONSORT 2010 Flow Diagram guidelines were followed during the research process."Personal Information Form", "State Anxiety Scale" and "Patient Follow-Up Form" were used to collect data in the study. Virtual reality was used as an intervention tool in the research. ntervention Tool Used in the Research: Virtual Reality VR Box brand virtual reality glasses were used in primiparous pregnant women undergoing cesarean section. The video, in which baby pictures will be shown accompanied by virtual reality music, was prepared by the researcher and a faculty member in the music department. During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes.
Data; It was collected face to face by the researcher at the Atatürk University Health Research and Application Center Obstetrics Clinic Operating Room between 01.11.2022 and 15.06.2023. It took an average of 5-10 minutes to fill out the forms.
Process steps Experimental group
- Written consent was obtained from pregnant women who agreed to participate in the study.
- 10 minutes before caesarean section; A personal information form was filled out to determine the descriptive characteristics of the pregnant women.
- Before cesarean section, anxiety level was determined with the State Anxiety Scale.
- Blood pressure, pulse, respiratory rate and saturation in the patient follow-up form were recorded.
- During the cesarean section, the pregnant woman was shown a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes.
- 10 minutes after cesarean section; In order to determine the anxiety level, the parameters in the State Anxiety Scale and the Patient Follow-up Form were measured again and the process was completed. control group
- Written consent was obtained from pregnant women who agreed to participate in the study.
- 10 minutes before cesarean section; A personal information form was filled out to determine the descriptive characteristics of the pregnant women.
- The pregnant woman's anxiety level before the procedure was determined using the State Anxiety Scale.
- Before the procedure, blood pressure, pulse, respiratory rate and saturation in the patient follow-up form were recorded.
- Routine practice was performed during cesarean section.
- 10 minutes after cesarean section; In order to determine the anxiety level, the parameters in the State Anxiety Scale and the Patient Follow-up Form were measured again and the process was completed.
After data collection, evaluation and analysis were done in the SPSS 22 package statistics program. Normality distributions of the data were examined. Skewness-kurtosis values were examined to check whether the data conformed to normal distribution and it was determined that the values of all data were between -1.5 and +1.5. It was determined that parametric testing techniques could be applied. In the analysis of data; number, percentage distribution, mean, standard deviation, chi-square, Independent-samples t test and paired-samples t test were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Virtual Realityvirtual reality glasses were used in primiparous pregnant women undergoing cesarean section. The video, in which baby pictures will be shown accompanied by virtual reality music, was prepared by the researcher and a faculty member in the music department. During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes. |
| Control group | No intervention | –* Written consent was obtained from pregnant women who agreed to participate in the study. * 10 minutes before cesarean section; A personal information form was filled out to determine the descriptive characteristics of the pregnant women. * The pregnant woman's anxiety level before the procedure was determined using the State Anxiety Scale. * Before the procedure, blood pressure, pulse, respiratory rate and saturation in the patient follow-up form were recorded. * Routine practice was performed during cesarean section. * 10 minutes after cesarean section; In order to determine the anxiety level, the parameters in the State Anxiety Scale and the Patient Follow-up Form were measured again and the process was completed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- • Having undergone epidural anesthesia, spinal anesthesia, combined anesthesia,
Key exclusion criteria (2 listed)
- • Leaving the study at any stage of the research
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 RealityVR Box brand virtual reality glasses were used in primiparous pregnant women undergoing cesarean section. During the cesarean section, the researcher showed the pregnant woman in the experimental group a video accompanied by music and baby pictures using virtual reality glasses for an average of 10 minutes. | Other | Experimental Group |
Primary outcome
Personal Information Form
Time frame: 8 months
There are 18 questions in this form, prepared by the researchers in line with the literature.
State Anxiety Scale
Time frame: 8 months
This scale was developed by Spielberger et al. Developed by. The adaptation of the scale to Turkish and its validity and reliability studies were carried out by Öner and Le Compte in 1983.The scale is a 4-point Likert scale consisting of the options "not at all", "somewhat", "a lot", "completely". There are 10 direct and 10 reversed statements in the scale. Positive (increasing the total anxiety score) for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18 in the scale; 1, 2, 5, 8, 10, 11, 15, 16, 19 Negative scores (reducing the total anxiety score) are obtained for the 20th items. The highest score is 80 and the lowest score is 20. A high total score indicates that the person's anxiety level is also high.Cronbach's alpha coefficient was found to be 0.79 for state anxiety. In this study, Cronbach's Alpha value was found to be 0.83.
Pregnant follow-up form
Time frame: 8 months
Blood pressure, pulse, respiration and the amount of oxygen in the blood were measured before and after the procedure and recorded on this form.
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 28 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Ayşe Aydın study director
Ataturk University
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 Cesarean Section Complications, run by Ataturk 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 11 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: finished, as of the sponsor's last update on 28 Mar 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?
Personal Information Form (time frame: 8 months). 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?
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 28 Mar 2024.