Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336421
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2024-03-22
Brief Title:
The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous During Cesarean Section
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean sectionThe research was conducted in a randomized controlled experimental designThe 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 Cohens standard field dimensions reference collection method was chosen in the image analysis Medium effect size 05 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 participatePregnant 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 processPersonal 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 01112022 and 15062023 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 womans 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 -15 and 15 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
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 processPersonal 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 01112022 and 15062023 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 womans 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 -15 and 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None