Clinical trial NCT06336421: The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous
Official title: The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Virtual Reality
Cesarean
Primiparous
Anxiety
Vital Signs
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* • 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.

Primary outcomes:
measure: Personal Information Form
timeFrame: 8 months
measure: State Anxiety Scale
timeFrame: 8 months
measure: Pregnant follow-up form
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yakutiye
country: Turkey
facility: Ayse Aydin
state: Erzurum
Study officials:
affiliation: Ataturk University
name: Ayşe Aydın
role: STUDY_DIRECTOR
References: