Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06336421 |
| Other study ID # |
Suletuvanç |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
March 22, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Ataturk University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 indication in the Ataturk University
Health Research and Application Center Gynecology Clinic Operating Room.
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.
