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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).

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

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.

Turkey (Türkiye)1 site
  • Ayse Aydin

    Yakutiye, Erzurum, 25000

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06336421
Study groupRoleWhat they receive
Experimental GroupExperimentalvirtual 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 groupNo 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.

  1. Personal Information Form

    There are 18 questions in this form, prepared by the researchers in line with the literature.

    Measured: 8 months

  2. 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

  3. 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.

  1. First posted28 Mar 2024
  2. Study start1 Nov 2022
  3. Primary completion15 Jun 2023
  4. Study completion22 Mar 2024

Resources

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)
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

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.

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