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Anxiety levels before cesarean delivery (CD) can lead to a negative birth experience, which may influence several aspects of the woman’s life in the long term. Improving preoperative information may lower preoperative anxiety and lead to a more positive birth experience.
This study aimed to determine whether a virtual reality (VR) video in addition to standard preoperative information decreases anxiety levels before a planned CD.
Women scheduled to undergo term elective CD were recruited from the outpatient clinic. They were randomized and stratified based on history of emergency CD (yes or no). All participants received standard preoperative information (folder leaflets and counseling by the obstetrician); the VR group additionally watched the VR video showing all aspects of CD such as the ward admission, operating theater, spinal analgesia, and moment of birth. The primary outcome measure was a change in score on the Visual Analogue Scale for Anxiety (ΔVAS-A) measured at admission for CD, compared with the baseline VAS-A score.
A total of 97 women were included for analysis. The baseline characteristics were similar in both groups, except for a significantly higher level of education in the control group. There was no significant decrease in the VAS-A score of the women in the VR group (n=49) compared with those in the control group (n=48; ΔVAS-A=1.0;
A VR video may help patients and their partners feel better prepared when planning a CD. This study showed that VR does not lead to a decrease in preoperative anxiety. However, subgroups such as women with a history of emergency CD may benefit from VR videos.
International Standard Randomised Controlled Trial Number (ISRCTN) 74794447; http://www.isrctn.com/ISRCTN74794447 (retrospectively registered)
A cesarean delivery (CD) is one of the most commonly performed surgeries in obstetrics, and the number of CDs performed is still increasing worldwide [
The CD procedure is mostly performed under regional anesthesia, without sedatives or anxiolytics, to facilitate a conscious birth experience for the mother, prevent depression of the neonate, and promote immediate (skin-to-skin) contact between the mother and her baby [
Previous research demonstrated that the level of anxiety and fear of childbirth are known to be associated with the incidence of postpartum depression. Women who deliver by a CD are at risk for both increased fear of childbirth and postpartum depression [
This is important because a negative birth experience is associated with serious negative long-term effects on several aspects of a woman’s life, such as the relationship with her partner and the baby and delay or even avoidance of future pregnancies [
Partners of women report anxiety and fear related to childbirth as well, especially with respect to a CD [
Currently, preoperative information is provided by the treating physician and through information folders. Ideally, a life guided tour and step-by-step explanation of the course of the procedure during the day should be part of the program for preparation. However, this elaborate preparation would require valuable time from the hospital personnel, and time is nowadays scarce and expensive. Owing to sterility issues, it is impossible to have a
To our knowledge, this is the first study to investigate the effect of VR in addition to conventional information provision on the preoperative anxiety levels of women undergoing a planned CD. Our primary hypothesis was that adding the VR video to standard preoperative information would show a statistically significant decrease in preoperative anxiety compared with providing the standard preoperative information without a VR video. In addition, we expected a positive effect of VR on patients’ levels of anxiety and patient satisfaction scores of both women and their partners. Furthermore, this study aimed to determine whether VR would be feasible to implement, without causing any harmful side effects such as motion sickness.
A total of eight women at the outpatient clinic who were scheduled to undergo a CD were interviewed. During this interview, we asked the women to describe their feelings in general and in terms of anxiety toward the planned CD as well as the way they received information about CD, their satisfaction with completeness of the information, and any possible improvements. We also asked for their opinion of the use of video and VR as possible information tools. All these women received information from their gynecologist and the internet, and one of them searched and watched a Web-based conventional video. Four women indicated that they would see additional value of information in a 2D video, whereas five women felt the same about VR. In addition, one woman indicated that she did not want to see a 2D video but was positive about a VR video because of the possibility of
The 360° VR video shows all the aspects of a CD, including the admission on the ward, the operating room, placement of spinal analgesia, and the birth of the baby when the gynecologist lifts the baby above the sterile environment (
Screenshot from the 360 virtual reality video at the moment of birth.
This randomized controlled trial included 80 women, enrolled from November 2016 to January 2018, who were scheduled for elective CD at Máxima Medical Center in Veldhoven, the Netherlands. We received a statement from our local institutional review board that no ethical approval was required (N17.017). Women were eligible for inclusion if they were aged 18 years or older, had planned for elective CD after 37 weeks of gestation, and had sufficient knowledge of the Dutch language. Exclusion criteria were prematurity (gestational age < 37 weeks), placenta previa, pre-eclampsia, and a suspected congenital anomaly. Patients were recruited from the outpatient clinic at our hospital. They were not explicitly informed that the study involved a VR video but were told that the intervention group received a novel method of information provision in addition to the standard information.
Randomization was performed by the researcher (LN) using a Web-based computer randomizer generating a randomization list. Couples were randomized into two groups by means of stratified block randomization: the control group received standard information from their doctor through information leaflets and oral counseling, and the intervention group (VR group) received the standard information and an additional VR video. Randomization blocks of 10 were used. Stratification was used based on the following two subgroups: (1) women with no history of CD and (2) women with previous emergency CD. The latter group was chosen, as these women may not have received elaborate information about the procedure before their first delivery because a vaginal delivery was intended. Masking of the researcher and participants was not possible because of the nature of the intervention.
After obtaining written informed consent, both women and their partners were asked to fill out the first questionnaire (time point 1). Subsequently, they were randomized into groups. If couples were randomized to the VR group, a VR video was shown using the Infor-Med app on the participant’s smartphone, and VR glasses (
Illustration of the virtual reality glasses used.
Time schedule and measured variables. *The intervention group additionally watched the 360° virtual reality video. £The intervention group additionally filled out the Simulation Sickness Questionnaire after watching the virtual reality video. CD: cesarean delivery; CPS: Childbirth Perception Scale; PCQ: Pregnancy and Childbirth Questionnaire; SSQ: Simulation Sickness Questionnaire; TPDS: Tilburg Pregnancy Distress Scale; VAS-A: Visual Analogue Scale for Anxiety.
The Simulation Sickness Questionnaire (SSQ) with 13 questions regarding the symptoms related to motion sickness was added to the first questionnaire for the VR group [
The VAS-A was used in the first and second questionnaires to measure preoperative anxiety [
The Tilburg Pregnancy Distress Scale was used in the first and second questionnaires. This questionnaire consists of 16 items regarding the woman’s perception of her pregnancy, divided over two subscales: negative affect and partner involvement. Questions are formed in positive and negative statements. Items were recoded such that a higher score represents a higher level of distress [
Sample size calculation was performed using the software G*power3 [
Statistical analyses were performed using SPSS (version 25; IBM Corporation, Armonk, New York). To test for differences in baseline characteristics between the two groups, a Student
As the history of emergency CD is known to be a predictor of preoperative anxiety, we performed a separate regression analysis to determine if there was a significant effect of the VR video in this subgroup alone. This was possible because of the stratified randomization applied.
For the same reason, differences in scores on the questionnaires were calculated separately for both the groups with and without a history of emergency CD. After recoding, the scores of the individual items were added to obtain an overall score. We calculated the difference between this overall score for each of the questionnaire subscales between the VR group and the control group using a Student
A total of 99 patients were included. Owing to the high number of missing questionnaires at the start of the study, we decided to continue including patients until we reached 80 completed questionnaires at time point 2, which included our primary outcome measure. Moreover, two patients were excluded because of spontaneous vaginal delivery after randomization. From the remaining 97 patients, we received 94% (91/97) completed questionnaires at time point 1, 87% (84/97) completed questionnaires at time point 2, and 73% (71/97) completed questionnaires at time point 3.
Flowchart of patient inclusion. CD: cesarean delivery; VR: virtual reality.
Baseline characteristics for both the VR group and the control group are shown in
Baseline characteristics of women undergoing cesarean delivery for both study groups (probability values were calculated using an independent
Characteristics | Virtual reality group (n=49) | Control group (n=48) | |||
Age (years), mean (SD) | 32.6 (3.9) | 33.12 (4.3) | |||
Gestational age (weeks) on delivery, mean (SD) | 39.0 (0.7) | 38.8 (0.8) | |||
Gravidity, median (IQRa) | 2 (1-3) | 2 (1-2) | |||
Parity, median (IQR) | 1 (0-1) | 1 (0-1) | |||
Previous CD, n (%) | 17 (35) | 16 (33) | |||
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Married | 30 (61) | 24 (50) | ||
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Living together | 15 (31) | 19 (40) | ||
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Single | 0 (0) | 2 (4) | ||
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Missing | 4 (8) | 3 (6) | ||
Body mass index (kg/m2), median (IQR) | 24.8 (22.9-29.2) | 24.9 (22.2-27.5) | |||
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Yes | 13 (27) | 10 (21) | ||
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No | 33 (67) | 35 (73) | ||
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Missing | 3 (6) | 3 (6) | ||
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University/college | 24 (49) | 32 (67) | ||
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Secondary education | 0 (0) | 3 (6) | ||
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Vocational training | 17 (35) | 8 (17) | ||
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Prevocational education | 5 (10) | 2 (4) | ||
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No education or primary education | 0 (0) | 0 (0) | ||
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Missing | 3 (6) | 3 (6) | ||
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Repeat CD | 14 (29) | 16 (33) | ||
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Fetal breech position | 24 (49) | 17 (35) | ||
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History of obstetric complications | 5 (10) | 8 (17) | ||
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Current obstetric complications | 0 (0) | 2 (4) | ||
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Medical history | 4 (8) | 2 (4) | ||
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Patient’s request | 2 (4) | 3 (6) | ||
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Health care professional | 38 (78) | 36 (75) | ||
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Patient folders | 37 (76) | 40 (83) | ||
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Experiences from friends/family | 24 (49) | 27 (56) | ||
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Internet | 25 (51) | 27 (56) | ||
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YouTube | 8 (16) | 10 (21) | ||
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Other | 8 (16) | 6 (13) |
aIQR: interquartile range.
bSignificant difference (
cCD: cesarean delivery.
There was no significant difference in the mean VAS-A score at admission between the control group and the VR group for both women (4.6 [SD 2.5] vs 5.6 [SD 2.4], respectively;
Difference in the Visual Analogue Scale for Anxiety value at time point 2 (at admission) between the virtual reality and the control groups for both women and their partners (difference calculated using the Student
Study arm | VAS-Aa Q1b, mean (SD) | VAS-A Q2c, mean (SD) | Change in score on the Visual Analogue Scale for Anxiety | Mean differenced | 95% CId | ||||||||
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1.0 | .08 | −0.1 to 2.0 | ||||||||||
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Control group | 3.8 (2.3) | 4.6 (2.5) | 0.8 |
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VRe group | 4.1 (2.3) | 5.6 (2.4) | 1.5 |
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0.6 | .30 | −0.5 to 1.6 | ||||||||||
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Control group | 2.5 (1.9) | 3.4 (2.0) | 0.9 |
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VR group | 2.5 (2.3) | 3.9 (2.5) | 1.4 |
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aVAS-A: Visual Analogue Scale for Anxiety.
bQ1: questionnaire time point 1.
cQ2: questionnaire time point 2.
dThese values are given for the change in score on the Visual Analogue Scale for Anxiety between the control group and the VR group for both women and their partners.
eVR: virtual reality.
The following variables showed a significant relation with ΔVAS-A: baseline VAS-A (
As we used stratified randomization, we were able to perform a separate analysis based on the history of CD using an interaction term. Increase in the baseline VAS-A score at time point 2 (at admission) in women in the VR group with a history of emergency CD was 1.7 cm smaller than that in women with a history of emergency CD in the control group, although this effect was not significant (
As there was a baseline difference in the level of education between both groups, we performed a regression analysis to analyze the effect of the different groups on the difference in VAS-A score, based on their level of education. By using dummy variables with university/college as a reference group, we were able to perform regression analysis on the categorical variables. If secondary education was the reference group, women had slightly lower VAS-A scores (0.2 cm). When vocational training or prevocational education was the reference group, the VAS-A scores were higher (0.5 and 0.2 cm, respectively). However, these results were not significant.
Median scores on the SSQ for motion sickness symptoms ranged from 1.0 to 1.5, reflecting the absence of discomfort caused by the VR video.
There was no significant difference in scores on the Tilburg Pregnancy Distress Scale subscales for both time points 1 and 2 between the VR group and the control group. The negative affect subscale showed higher scores at time point 2 than at time point 1 (control group, 25.2 [SD 3.9] vs 9.4 [SD 4.9]; VR group, 23.8 [SD 4.4] vs 9.1 [SD 4.4]), but this increase was equally present in both study arms.
For the PCQ questionnaire after delivery, we found a significantly higher score for the VR group without a history of emergency CD, indicating that they perceived a higher quality of care than the control group (10.2 [SD 3.8] vs 12.9 [SD 3.5];
We received 26 completed questionnaires from time point 3 from women in which the question regarding the additional value of the VR video was filled in. Of the 26 women, 4 (15%) responded that they did not feel more prepared after seeing the VR video. The remaining 22 (85%) women responded positively. From the partners, 24 questionnaires were completed from time point 3 including this question, of which 19 (79%) partners responded positively. The remaining 5 (21%) partners did not feel more prepared after seeing the VR video.
In this study, we aimed to assess the effect of adding a VR video as part of standard preoperative information before planned CD on the information level of women and their partners and the woman’s level of anxiety. Our data showed that VR is not related to a significant decrease in self-reported preoperative anxiety for both women and their partners compared with a no VR condition. Only women with a history of emergency CD showed a trend toward decreased preoperative anxiety. With regard to the quality of care, women and their partners perceived a higher quality of care after watching the VR video.
Our preoperative VAS-A scores match those previously described in the literature [
Besides the sociodemographic features (level of education and marital status), other factors such as presence of previous psychiatric disorders are known to influence preoperative anxiety. Women with a history of anxiety are more likely to experience fear of childbirth than others [
Another known risk factor for fear of childbirth is previous emergency CD [
Literature about the use of (virtual) information videos in patient counseling report conflicting results of their effect on preoperative anxiety [
Although there was no significant difference in the main outcome measure, we found a trend toward decreased preoperative anxiety in the subgroup of women with a history of emergency CD after watching the VR video. This indicates that this subgroup of patients may benefit from this method of preoperative information. Careful selection of subgroups is the next step before implementing this information medium as part of standard care. Offering the VR video without obligation as part of the preoperative information at the outpatient clinic could help in gaining insight into the target population. Through tracking which and how many patients watch the VR video, it may be possible to assess the characteristics of this patient population interested in the video. However, patient privacy regulations make it difficult to facilitate this. Anonymous feedback questions provided through the mobile app after watching the video may add in retrieving this information. In addition, in the group of patients who waive the possibility of watching the VR video, it is important to ask for their reasons, which can be used in optimizing the content of the VR video.
With the rise of this innovative modality, a guideline toward the setup of clinical studies concerning the use of VR has recently been published. The authors recommend a three-phase development and validation process to uniformize the development and validation of VR applications [
There are several limitations to this study. First, power calculations were made based on the primary outcome measure (preoperative VAS-A score). Therefore, this study may be underpowered to show significant differences in results from the questionnaires designed to measure psychological functioning in the perinatal period. The only significant result was a higher score on the PCQ questionnaire for the VR group without a history of emergency CD, indicating that they perceived a higher quality of care than the control group. However, the absolute difference between both groups is small and therefore not clinically significant. The relatively small study population is a limitation for each of the subanalyses performed in our study.
Second, we did not keep track of the number of people who refused to participate in the study and their arguments for refusal. This may have led to a selection bias because patients who are not keen on watching the VR video may be more likely to refuse when asked to participate. In addition, we did not verify if all participants who were randomized to the VR group actually watched the entire VR video. Although most participants watched the VR video at the time of inclusion, some chose to watch the video at home in their own environment. Therefore, there is a chance that some of them did not see the video, and including these completed questionnaires in our analysis could have caused a bias.
Fourth, there was a high amount of missing data because of missing questionnaires. We distributed paper questionnaires to patients at the time of inclusion and placed duplicate questionnaires at the ward where patients were admitted for CD. The researchers actively pursued the questionnaires. Despite our efforts, the percentage of missing questionnaires remained high, especially for questionnaire form 3. In future studies, electronic questionnaires available through a mobile app on a smartphone could facilitate this process.
Our study did not show a decrease in preoperative anxiety after VR information provision for patients undergoing elective CD. There was a trend toward decreased preoperative anxiety in the subgroup of women with a history of emergency CD who watched the VR video. Further research for identifying the characteristics of subgroups of patients who would potentially benefit from VR information provision is necessary.
Translated version of the postdelivery questionnaire for partners (questionnaire 3).
CONSORT-EHEALTH checklist (V 1.6.1).
cesarean delivery
Childbirth Perception Scale
Pregnancy and Childbirth Questionnaire
Simulation Sickness Questionnaire
Visual Analogue Scale for Anxiety
virtual reality
change in score on the Visual Analogue Scale for Anxiety
SvR was the founder of Infor-Med BV. All other authors have no conflicts of interest to declare.
This randomized study was only retrospectively registered. The editor granted an exception from ICMJE rules mandating prospective registration of randomized trials because the risk of bias appears low and the study was considered formative, guiding the development of the application. However, readers are advised to carefully assess the validity of any potential explicit or implicit claims related to primary outcomes or effectiveness, as retrospective registration does not prevent authors from changing their outcome measures retrospectively.