Study design
This was a randomized, controlled, single-center clinical trial in which we enrolled 42 women admitted during labor. We randomized these women to an immersive virtual reality (VR) or control group following their approval and written consent. The study was approved by the Institutional Ethics Committee of Acibadem Mehmet Ali Aydinlar University (IRB protocol no: 2020–18/07) and registered with clinicaltrials.gov (NCT05032456). The goal of this study was to assess whether immersive VR improved patient satisfaction in laboring women. We assessed patient satisfaction among VR users and compared patient satisfaction scores regarding the overall childbirth experience between the two groups as our primary objective. Our second objective was to assess whether VR provided pain relief in the latent or active phase of labor. We also evaluated anxiety and depression in both groups on admission as potential confounders. The study took place at Acibadem Maslak Hospital, a private hospital affiliated with Acibadem University School of Medicine in Istanbul, Turkey. Enrollment completed between November 2020 and June 2021.
Study subjects
Participants in this study were primigravida or multigravida presenting with labor who were candidates for vaginal birth with no known risk factors. The inclusion criteria were women between 18–42 years of age at 37–41 weeks gestation with a singleton pregnancy, vertex presentation, no history of chronic medical conditions, absence of pregnancy complications, and admission with documented labor by cervical exam and regular uterine contractions. Women with a diagnosis of migraine, headache, dizziness, motion sickness, epilepsy, psychiatric disorders, visual or auditory disabilities, or history of cesarean section were excluded.
Pregnant women between 35 and 37 weeks gestation who were followed by our Obstetric Outpatient Clinic at Acibadem Maslak Hospital were provided information leaflets for our VR study by one of the authors (NA). We have ‘Preparation to birth’ classes for expecting couples one every 6 weeks, and during each of those courses, NA briefly introduced our study, its objectives and handed information leaflets to attendants.
VR group
We used an Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system. Before the intervention, the authors introduced the equipment and instructed study participants on how to wear and activate the headsets. Anxiety and depression scales were also applied on admission. The laboring women who enrolled in the VR group first wore the headsets in early labor (cervical dilation 3 cm) for 20 min. The patients were offered to choose among several virtual environments, including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall (Fig. 1). Cards printed out from the screenshots of the Nature Treks application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance. The second implementation of VR headsets was after epidural analgesia was administered in the active phase of labor (cervical dilation 6–7 cm); this implementation was also for 20 min. After the second intervention, the “Virtual Reality Satisfaction Survey” was applied by the authors. Patients were asked to fill out a visual pain rating scale immediately before and after VR use in early and active labor.
Control group
For participants randomized to the control group, VR headsets were not used, and our standard of care in laboring women was followed. Anxiety and depression scales were used to evaluate to each subject on admission. Participants in this group completed a visual pain rating scale both in the latent and active phases of labor.
Clinical measures
To evaluate the effectiveness of immersive VR in laboring women, we evaluated patient satisfaction with the use of VR among the intervention group. Patient satisfaction with the overall childbirth experience and pain scores were compared between the intervention and control groups.
Patient satisfaction with the use of VR was assessed by a "Virtual Reality Satisfaction Survey", a 10-question survey prepared by our team and measured with a visual analog scale (VAS) score. 0 being the lowest and 100 being the highest possible VR satisfaction score. We also asked these women whether they would like to use VR in future labor. Patient satisfaction with overall labor and delivery experience was assessed using a numeric rating scale (NRS). All discharged women were called within a week following discharge and asked to rate their overall childbirth experience on a scale from 0 to 10. Zero indicates the most negative experience possible, and 10 indicates the highest satisfaction possible. We classified a score of 8 to 10 as high satisfaction and a score of 4 or less as poor childbirth experience. Pain scores in both early and active labor in each group were assessed using the Wong-Baker Faces Pain Rating Scale [15]. The scale shows a series of 6 faces ranging from a happy face at 0, or "no hurt", to a crying face at 5, which represents "hurts like the worst pain imaginable (Fig. 2).
The anxiety levels of the study participants were assessed with the Beck Anxiety Inventory (BAI) [16]. This inventory consists of 21 items, each scored from 0 to 3. This is a self-report questionnaire measuring somatic and cognitive parts of anxiety. The total score is calculated by finding the sum of 21 items. A score of 0 to 7 indicates minimal anxiety, 8 to 15 indicates mild anxiety, 16 to 25 indicates moderate anxiety, and 30 to 63 is associated with severe anxiety.
For the assessment of depression in each group, the Beck Depression Inventory was used. It consists of 21 items, which is a multiple-choice test and gives a score ranging from 0 to 63. Each answer is scored on a scale value of 0–3. Measures of 0–9 indicate that a person is not depressed, 10–18 indicates mild-moderate depression, 19–29 indicates moderate-severe depression and 30–63 indicates severe depression. This self-rated test estimates the signs of depression, such as pessimism, feelings of failure, self-dissatisfaction, punishment, crying, and insomnia [17, 18].
Statistical methods
Sample size calculation and randomization
A priori power analysis was performed to estimate the sample size with a power (1-β) of 80%, a significance (α) of 0.05 and an allocation ratio of 1. We assumed a neutral satisfaction score of 50 out of 100 (SD = 12.5) for the control group and hypothesized.
25% increase in satisfaction scores with the use of VR. A sample size of 17 subjects per group was computed to observe this difference. For this analysis, G*Power software was used. For potential dropouts, we decided to enroll 21 subjects in each group. We used a random sequence generator (www.random.org), which picked a random sequence of 21 numbers (ranging from 1 to 42) for VR and control columns, respectively. This list was printed and kept in a locked cabinet at the nurses` station of Labor and Delivery floor. Following consent, we asked study participants to pick up a sealed opaque envelope, each containing a number from 1 to 42. Our charge nurse matched this number to the list of numbers for VR or the control group determining their assignment. This method helped to conceal the allocation sequence and provided that an equal number of subjects (n = 21) were randomized to the intervention (VR) and control groups. Since the intervention group wore VR headsets and the control group did not, blinding was not possible.
Data analysis
Statistical analyses were performed using IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. Descriptive statistics are presented as the mean score, standard deviation and absolute frequency. The Shapiro–Wilk test was used to analyze whether the continuous variables followed a normal distribution. To compare the mean overall childbirth satisfaction scores as well as anxiety and depression scores between the two groups, an independent t test or Mann–Whitney U test was used where appropriate. We used a paired samples t test or Wilcoxon t test where appropriate for the comparison of pain scores before and after the VR experience in early and active labor. A p value of less than 0.05 was considered statistically significant.